Clinical cure of bacterial conjunctivitis with azithromycin 1%: vehicle-controlled, double-masked clinical trial

PURPOSE: To analyze the effect of azithromycin 1% ophthalmic solution in DuraSite (InSite Vision, Inc, Alameda, California, USA) on bacterial conjunctivitis. DESIGN: Prospective, randomized, vehicle-controlled, parallel-group, double-masked multicenter clinical study. METHODS: Eligible male or female participants with a clinical diagnosis of acute bacterial conjunctivitis were randomized to either 1% azithromycin in DuraSite or vehicle for five days. Infected eyes were dosed twice daily on days 1 and 2 and once daily on days 3 through 5. Conjunctival cultures were obtained at baseline, visit 2 (day 3 or 4), and visit 3 (day 6 or 7). The primary end point was clinical resolution of signs and symptoms (rating of zero on ocular discharge, bulbar and palpebral injection) at visit 3. Efficacy measures were clinical resolution and bacterial eradication as evaluated in the per-protocol population. Safety was assessed by adverse events, slit-lamp findings, and ophthalmoscopy. RESULTS: Two hundred and seventy-nine participants (n = 130, 1% azithromycin in DuraSite; n = 149, vehicle), age one to 96 years, were evaluated for efficacy. Clinical resolution with azithromycin ophthalmic solution was statistically significant compared with that of vehicle (P = .030) at visit 3. Bacterial eradication rates with azithromycin ophthalmic solution reached 88.5% at visit 3 (P < .001) and included some pathogens resistant to azithromycin in vitro. Overall, adverse event rates were similar in both treatment groups. CONCLUSIONS: Azithromycin 1% ophthalmic solution in DuraSite showed statistically significant differences in clinical resolution and bacterial eradication rates when compared with vehicle. Because it was well tolerated in this population, it may be a viable treatment option for children and adults with bacterial conjunctivitis.     

3-day treatment with azithromycin 1.5% eye drops versus 7-day treatment with tobramycin 0.3% for purulent bacterial conjunctivitis: multicentre, randomised and controlled trial in adults and children

AIM: To compare the efficacy and safety of Azyter, azithromycin 1.5% eye drops, for 3 days with tobramycin 0.3% for 7 days to treat purulent bacterial conjunctivitis. METHODS: This was a multicentre, randomised, investigator-masked study including 1043 children and adults with purulent bacterial conjunctivitis. Patients received either azithromycin 1.5% twice-daily for 3 days or tobramycin 0.3%, 1 drop every two hours for 2 days, then four times daily for 5 days. Clinical signs were evaluated and cultures obtained at D0, D3 and D9 (where D refers to "day"). Primary variable was the clinical cure at the Test-of-Cure (TOC)-visit (D9+/-1), for patients with D0-positive cultures. The cure was defined as: bulbar conjunctival injection and discharge scores of 0. RESULTS: Among 471 patients with D0-positivity in the per protocol set, 87.8% of the azithromycin 1.5% group and 89.4% of the tobramycin group were clinically cured at the TOC-visit. Azithromycin was non-inferior to tobramycin for clinical and bacteriological cure. Clinical cure was significantly higher with azithromycin 1.5% at D3. The safety profile of azithromycin was satisfactory with a good patient and investigator's acceptability. CONCLUSIONS: Azithromycin 1.5% for 3 days was as effective and as safe as tobramycin for 7 days. Furthermore, more azithromycin than tobramycin patients presented an early clinical cure at Day 3. Due to its twice daily dosing regimen for 3 days, azithromycin represents a step forward in the management of purulent bacterial conjunctivitis, especially in children.     

A clinical comparison of two formulations of tobramycin 0.3% eyedrops in the treatment of acute bacterial conjunctivitis

PURPOSE: To compare the safety and efficacy of a new enhanced viscosity ophthalmic formulation of tobramycin, given twice daily (BID), with the existing four times daily (QID) treatment regimen in patients with acute bacterial conjunctivitis. METHODS: This was a 12-day, multicenter, observer-masked, randomized, parallel group study. Patients received one drop of tobramycin 0.3% (3 mg/mL) enhanced viscosity ophthalmic solution BID or tobramycin 0.3% (3 mg/mL) ophthalmic solution QID in the affected eyes for 7 days. The primary efficacy variable was the percentage of patients with sustained cure/presumed bacterial eradication based on clinical judgment at the test-of-cure visit (Day 12). Pretherapy bacterial isolates were obtained and tested for susceptibility to tobramycin by determination of minimum inhibitory concentrations (MIC). RESULTS: A total of 276 patients were enrolled in the study and 203 of these were culture positive and attended all follow-up examinations. In this group, 98% of those treated with tobramycin enhanced viscosity ophthalmic solution and 99% of those treated with tobramycin 0.3% ophthalmic solution were categorized as having sustained cure/presumed eradication at the test-of-cure visit (p = 0.6037). Reported adverse events were not serious, mild to moderate in severity, and generally did not prevent continuation in the study. Several pre treatment pathogens demonstrated tobramycin resistance (MIC > 4 mg/mL). However, therapy with both treatments was effective in the majority of the cases. CONCLUSIONS: Tobramycin enhanced viscosity ophthalmic solution is well tolerated and has equivalent efficacy to the established treatment regimen with a simplified posology. The formulation provides an alternative therapy for acute bacterial conjunctivitis that should improve patient compliance and satisfaction.     

Treatment of acute bacterial conjunctivitis: 1% fusidic acid viscous drops vs. 0.3% tobramycin drops

BACKGROUND: A frequent cause of conjunctivitis is an acute bacterial infection, presenting with mucopurulent discharge and conjunctival hyperemia. The authors compared the clinical and microbiologic efficacy, safety and acceptability of 1% fusidic acid viscous drops (Fucithalmic) with 0.3% tobramycin ophthalmic solution (Tobrex) in the treatment of suspected bacterial conjunctivitis. METHODS: Patients were recruited at 20 sites in Ontario, Saskatchewan and Alberta from October 1995 to December 1998. Patients who presented to their primary care physician with suspected bacterial conjunctivitis, as identified by conjunctival hyperemia and purulent or mucopurulent discharge, were eligible for the study. Patients were randomly assigned to receive 7 days of treatment with either 1% fusidic acid (one drop applied twice daily) or 0.3% tobramycin (one to two drops applied four to six times daily). The investigators were blinded as to treatment status. Bacteriologic samples were taken from the inferior conjunctival cul-de-sac on day 0 and at the end of treatment. Signs and symptoms of conjunctivitis were assessed at baseline and after 3 and 7 days of treatment. The acceptability of treatment was assessed by having the patient or the parent or guardian complete a questionnaire on degree of compliance and ease of use after 3 and 7 days of treatment. RESULTS: Conjunctival swabs were obtained from 484 patients (410 over 9 years of age and 74 aged 2 to 9 years) to determine baseline bacteriology. Of the 484, 319 (65.9%) (63% of the older patients and 80% of those aged 2 to 9 years) had positive results of culture for bacteria. Ninety-four patients (19%) (63 [15%] of the older patients and 31 [42%] of those aged 2 to 9 years) had per-protocol pathogens as defined by quantitative bacteriology criteria. There was a direct correlation between the presence of mucopurulent discharge and the presence of per-protocol pathogens. There were no significant differences in clinical or bacteriologic efficacy between the treatment groups. Treatment compliance was similar between the treatment groups for the older patients; however, for those aged 2 to 9 years, compliance was significantly better in the fusidic acid group than in the tobramycin group (85% vs. 47%) (p < 0.001). Significantly more patients in the fusidic acid group than in the tobramycin group rated treatment as convenient or very convenient, particularly among younger patients (97% vs. 54%) (p < 0.001). INTERPRETATION: The clinical and bacteriologic efficacy of fusidic acid viscous drops combined with the convenience of a twice-daily dosage regimen establishes this antibiotic as first-line treatment for suspected acute bacterial conjunctivitis and a favourable alternative to other broad-spectrum antibiotics.     

Clinical efficacy of ciprofloxacin 0.3%9 (Ciloxan) in the treatment of bacterial infections of the external eye segment

PURPOSE: The main subject of the study was to evaluate efficacy of ciprofloxacin 0.3% ophthalmic solution (Ciloxan) in the treatment of bacterial conjunctivitis and surgical prophylaxis. Safety and comfort of topical ciprofloxacin treatment was also examined. MATERIAL AND METHODS: Two study arms: 99 patients with bacterial conjunctivitis (A group) and 48 patients awaiting cataract surgery (B group--total 147 subjects in both groups) received ciprofloxacin 0.3% ophthalmic solution (Ciloxan) 4 doses a day for seven days. Bacteriological evaluation was established before and after treatment for each eye. RESULTS: 95 out of the 99 patients (96%) in the first arm were completely cured (all signs and symptoms of the bacterial conjunctivitis were eliminated). In the second arm complete eradication of bacterial flora was achieved in 46 out of 48 pretreated patients (96%). CONCLUSIONS: Topical ciprofloxacin 0.3% (iloxan) was found very effective and fast in reduction of typical signs and symptoms of bacterial conjunctivitis as well as in eradication of bacterial flora before surgery treatment.     

A phase III clinical trial of 0.5% levofloxacin ophthalmic solution versus 0.3% ofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis

OBJECTIVE: To compare the efficacy and safety of 0.5% levofloxacin ophthalmic solution (QUIXIN) with 0.3% ofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis. DESIGN: Prospective, randomized, active-controlled, double-masked, multicenter study. PARTICIPANTS: Four hundred twenty-three patients with a clinical diagnosis of bacterial conjunctivitis were enrolled. METHODS: Patients were randomly assigned to receive either 0.5% levofloxacin (n = 211) or 0.3% ofloxacin (n = 212) for 5 days (every 2 hours on days 1 and 2 and every 4 hours on days 3-5). Conjunctival cultures were obtained, and ocular signs and symptoms were evaluated on day 1 (baseline), days 3 to 5 (interim), and days 6 to 10 (final). End point was defined as the last evaluable observation. MAIN OUTCOME MEASURES: Primary microbial and clinical outcomes were based on culture results and resolution of cardinal signs, respectively. Secondary efficacy assessments included evaluations of ocular signs and symptoms. RESULTS: Two hundred eight patients (levofloxacin, n = 109; ofloxacin, n = 99) were evaluated for efficacy. Microbial eradication rates were significantly greater in the 0.5% levofloxacin treatment group compared with the 0.3% ofloxacin group at both the final visit (89% vs. 80%, P = 0.034) and at end point (90% vs. 81%; P = 0.038). Treatment with 0.5% levofloxacin was significantly more effective in resolving photophobia than was 0.3% ofloxacin treatment (94% vs. 73%, P = 0.006). Both study medications were well tolerated, with a low incidence of adverse events. CONCLUSIONS: Although clinical cure rates in the 0.5% levofloxacin and 0.3% ofloxacin treatment groups were similar, a 5-day treatment regimen with 0.5% levofloxacin achieved microbial eradication rates that were statistically superior to those attained with 0.3% ofloxacin. Despite the higher concentration of active drug in 0.5% levofloxacin versus 0.3% ofloxacin, there was no difference between treatment groups in the incidence of treatment-related adverse events.     

Efficacy and safety of 0.5% levofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis in pediatric patients.

PURPOSE: To compare the efficacy and safety of 0.5% levofloxacin ophthalmic solution (Quixin; Santen, Napa, CA) with 0.3% ofloxacin (Ocuflox; Allergan Inc., Irvine, CA) and placebo for the treatment of pediatric bacterial conjunctivitis. METHODS: This study was a subset analysis of 167 pediatric patients (age range, 1 to 16 years) from two randomized, double-masked, multicenter, parallel group studies. Eye drops were instilled every 2 hours on days 1 and 2 and every 4 hours on days 3 through 5. Ocular signs and symptoms were noted, and conjunctival cultures were obtained on day 1 (baseline), days 3 to 5 (interim), and days 6 to 10 (final). Endpoint was defined as the last evaluable observation. Microbial and clinical outcomes were based on culture results and cardinal signs, respectively. RESULTS: At endpoint (mean of 6.5 days for 118 evaluable patients), 0.5% levofloxacin treatment demonstrated greater microbial eradication rates (percentage of patients with absence of causative organisms cultured at baseline) compared with 0.3% ofloxacin or placebo. In children age 2 to 11 years, this finding was statistically significant in favor of 0.5% levofloxacin (87% vs 62% with 0.3% ofloxacin [P < or =.032] and 88% vs 24% with placebo [P <.001]). No significant differences between treatment groups in microbial eradication rates were noted in other age subgroups. CONCLUSIONS: After 5 days of therapy, 0.5% levofloxacin ophthalmic solution was found to be safe and effective in treating pediatric bacterial conjunctivitis. Treatment with 0.5% levofloxacin achieved microbial eradication rates in children that were statistically superior to those attained with 0.3% ofloxacin or placebo.     

盐酸左氧氟沙星滴眼液治疗细菌性结膜炎及角膜炎随机双盲对照临床研究

目的　比较北京医工生物技术研究所研制的 15mg/5mL盐酸左氧氟沙星滴眼液和海伦滴眼液治疗细菌性结膜炎、角膜炎的疗效和安全性。方法　用随机、双盲、平行研究。共选择 60例患者分为试验组和对照组各 3 0例。疗程 3～ 14d ,主要疗效参数为治疗第 7、14d的临床疗效。结果　用药 7d细菌性结膜炎和角膜炎试验组总有效率为 72 %( 18/2 5 ) ;对照组总有效率为 84 62 % ( 2 2 /2 6)。用药 14d细菌性结膜炎和角膜炎试验组总有效率为 10 0 % ( 2 5 /2 5 ) ;对照组总有效率为 96 15 % ( 2 5 /2 6) ,两组间细菌性结膜炎和角膜炎总有效率无统计学差异。试验组和对照组对细菌性结膜炎和角膜炎的疗效相当。细菌性结膜炎和角膜炎试验组细菌清除率为 10 0 % ;对照组总清除率 98 0 4% ,两组间清除率比较无显著性差异 (P >0 0 5 )。试验组与对照组均有良好的耐受性 ,无明显不良反应发生。结论　盐酸左氧氟沙星滴眼液治疗细菌性结膜炎和细菌性角膜炎有效且安全。     

Clinical evaluation of twice-daily emedastine 0.05% eye drops (Emadine eye drops) versus levocabastine 0.05% eye drops in patients with allergic conjunctivitis

PURPOSE: The efficacy and safety of emedastine 0.05% eye drops (Emadine; Alcon Laboratories, Inc, Fort Worth, Texas), a new H(1) antagonist, were studied in comparison to levocabastine 0.05% eye drops (Livostin; Janssen-Cilag N V, Berchem, Belgium) during a twice-daily treatment schedule for 6 weeks in adult and pediatric patients with seasonal allergic conjunctivitis. METHODS: In a prospective, multicenter, randomized, double-masked, parallel group study, 222 patients with allergic conjunctivitis were randomized (221 received treatment) to either emedastine or levocabastine, instilled twice daily for 6 weeks. Patient diaries were completed four times daily (before the morning and evening instillations, at noon, and in the afternoon), and clinical examinations were conducted at regular intervals. Primary efficacy variables of ocular redness and itching and secondary efficacy variables of chemosis, eyelid swelling, patient diary data, and physician's global assessment were analyzed. RESULTS: Both emedastine and levocabastine produced a statistically significant (P =.0001) reduction in itching and redness within 5 minutes of the first instillation. All signs and symptoms improved progressively over the 6-week treatment period. After 7 days of use, and throughout the remainder of the study, emedastine was statistically superior to levocabastine (P <.006) in preventing and alleviating the signs and symptoms (itching, redness, chemosis, and eyelid swelling) of allergic conjunctivitis. CONCLUSIONS: Emedastine 0.05% eye drops administered twice daily are more efficacious than levocabastine 0.05% eye drops in the prevention and treatment of the signs and symptoms of allergic conjunctivitis in adults and children of 4 years and above. Both emedastine 0.05% eye drops and levocabastine 0.05% eye drops were well tolerated.     

Meta-analysis of six clinical phase III studies comparing lomefloxacin 0.3% eye drops twice daily to five standard antibiotics in patients with acute bacterial conjunctivitis

· Background: Lomefloxacin 0.3% ophthalmic solution twice daily has been compared in patients with bacterial conjunctivitis in six randomized double-blind or investigator-masked phase III studies with either chloramphenicol 0.5% 5×/day, gentamicin 0.3% 4×/day, fusidic acid 1% 2×/day, tobramycin 0.3% 4×/day or norfloxacin 0.3% 4×/day. · Methods: A meta-analysis of all individual data of these six studies was performed. A total of 582 patients with clinically diagnosed bacterial conjunctivitis were evaluated by slit-lamp examination with grading of eight key signs and symptoms and by conjunctival swab cultures at baseline, on day 3–5 and on day 7–9. Success of therapy, local tolerance and safety were evaluated at termination. In vitro sensitivity of the ocular isolates to 6–10 antibiotics was evaluated by disk diffusion tests. · Results: Two hundred and ninety patients treated with lomefloxacin 0.3% (LF) and 292 patients treated by one of the control antibiotics (combined control group, CCG) were enrolled in the studies. Two hundred and seventy-eight LF and 283 CCG patients were evaluable for the intent-to-treat (ITT) analysis, while 85 LF and 95 CCG patients had bacteria above the pathological threshold and formed the core subpopulation. The mean cumulative sum score in the LF group was 9.47 on day 1, and decreased by 5.70 on day 3–5 and by 8.10 on day 7–9. In the CCG it decreased significantly less: it was 9.19 at baseline, decreased by 5.15 on day 3–5 and by 7.33 on day 7–9. Swab counts decreased in the LF and CCG group similarly, with the major decrease observed between day 1 and day 3–5. Most of the organisms considered resistant in vitro were still eradicated with the regimen used. Of the few surviving organisms also isolated on the next follow-up visit, one isolate in the LF group and seven in the CCG showed decreased in vitro sensitivity towards the treatment antibiotic used. Local tolerance was good or excellent, without any significant differences except for burning sensation, which lasted significantly longer in the CCG group than in the LF group. Adverse events were observed in 18 LF and 23 CCG patients; four LF and three CCG patients had to be withdrawn. All adverse events were non-serious. · Conclusion: Lomefloxacin eye drops used with a loading dosage followed by a twice daily regimen proved as effective, safe and well tolerated as five established standard treatments used at a 2, 4 or 5 times daily regimen, caused less discomfort upon instillation, and showed a lower risk to generate or select new resistant strains. Received: 24 November 1998 Revised version received: 4 January 1999 Accepted: 5 January 1999     

A phase III,placebo controlled clinical trial of 0.5% levofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis

AIM: To compare the efficacy and safety of levofloxacin 0.5% ophthalmic solution (Quixin) with placebo for treatment of bacterial conjunctivitis. METHODS: In this prospective, randomised, placebo controlled, double masked, multicentre study, 249 patients with bacterial conjunctivitis received either 0.5% levofloxacin (n = 126) or placebo (n = 123) for 5 days, administered every 2 hours on days 1-2, then every 4 hours on days 3-5. Cultures were obtained and signs/symptoms evaluated at baseline, interim, and final visits. The end point was the last evaluable observation. Primary microbial outcomes were based on culture results; clinical outcomes were based on resolution of cardinal signs. RESULTS: 117 patients (60 levofloxacin, 57 placebo) were evaluated. Microbial eradication rates were significantly greater with levofloxacin at all time points, reaching 90% at end point. In a subgroup analysis, differences in eradication rates at end point were most pronounced in children but were also statistically significant for levofloxacin in adults. Clinical cure rates were significantly greater with levofloxacin at final visit and end point. Statistically significant differences favouring levofloxacin were measured at end point for resolution of conjunctival discharge, bulbar conjunctival injection, palpebral conjunctival injection, burning/stinging, itching, and photophobia. Adverse events were similar between groups. Safety composite scores analysed by age indicated significantly fewer children on levofloxacin experienced worsening symptoms. CONCLUSIONS: Levofloxacin 0.5% ophthalmic solution is safe and effective for treatment of bacterial conjunctivitis.     

Clinical safety of moxifloxacin ophthalmic solution 0.5% (VIGAMOX) in pediatric and nonpediatric patients with bacterial conjunctivitis

Five independent, multicentered, double-masked, parallel, controlled studies were conducted to determine the safety of moxifloxacin ophthalmic solution 0.5% (VIGAMOX) in pediatric and nonpediatric patients with bacterial conjunctivitis. Patients were randomized into one of two treatment groups in each study and received either moxifloxacin ophthalmic solution 0.5% b.i.d. or t.i.d. or a comparator. A total of 1,978 patients (918 pediatric and 1,060 nonpediatric) was evaluable for safety. The most frequent adverse event in the overall safety population was transient ocular discomfort, occurring at an incidence of 2.8%, which was similar to that observed with the vehicle. No treatment-related changes in ocular signs or visual acuity were observed with moxifloxacin ophthalmic solution 0.5%, except for one clinically relevant change in visual acuity. Thus, based upon a review of adverse events and an assessment of ocular parameters, moxifloxacin ophthalmic solution 0.5% formulated without the preservative, benzalkonium chloride, is safe and well tolerated in pediatric (3 days-17 years of age) and nonpediatric (18-93 years) patients with bacterial conjunctivitis.     

Topical lomefloxacin 0.3% twice daily versus tobramycin 0.3% in acute bacterial conjunctivitis: A multicenter double-blind phase III study.

AIMS/BACKGROUND: To evaluate in a double-masked comparative, prospective, randomized multicenter trial the efficacy of lomefloxacin 0.3% eye drops twice daily and of tobramycin eye drops 4 times daily in patients with acute bacterial conjunctivitis. METHODS: Ninety-nine subjects were enrolled: 50 were treated with lomefloxacin 0.3% eye drops twice daily and 49 with tobramycin 0.3% eye drops 4 times daily. In all patients, conjunctival swabbing and assessment of objective signs and of subjective symptoms were performed. RESULTS: There was no statistical difference for any individual sign or symptom or for the sum score of either key or other signs and symptoms at any of the examination days. The sum score of both key and other signs and symptoms decreased in both groups at day 3-4 as compared to baseline values (p < 0.0001). The decrease in both these scores continued significantly from day 3-4 to day 7-8 (p < 0.05) and was similar in the two treatment groups (p > 0.4). The lowest resistance rate was seen in lomefloxacin (3.5%) and in neomycin (7.0%), while tobramycin showed resistance in 10 out of 88 resistance strains (11.4%). CONCLUSION: Both lomefloxacin 0.3% twice daily and tobramycin 0.3% administered 4 times daily were well tolerated and showed a high degree of clinical and microbiological efficacy in the treatment of acute bacterial conjunctivitis. Lomefloxacin caused less resistance than other antibiotics evaluated.     

加替沙星滴眼液治疗细菌性结膜炎临床分析

目的 探讨加替沙星滴眼液治疗细菌性结膜炎的临床效果.方法 加替沙星组和氧氟沙星组各为120例,合计240例.采用计算机编程随机法,随机双盲对照试验.患者的纳入应能满足所有入选及排除标准,随机分为加替沙星组和氧氟沙星组,分别给予加替沙星滴眼液和相同浓度对照药氧氟沙星滴眼液,疗程7～14天.加替沙星滴眼液组:每日5次,每次1～2滴,滴入结膜囊内,氧氟沙星滴眼液组:每日5次,每次1～2滴,滴入结膜囊内,随诊观察.结果 本研究共分离临床敛病菌67株,其对加替沙星、氧氟沙星、左氧氟沙星和环丙沙星的敏感率分别为98.51%、85.07%、95.52%、78.79%.表明加替沙星的细菌敏感率最高,与氧氟沙星比较,差异有统计学意义.加替沙星滴眼液治疗细菌性结膜炎的疗效不低于氧氟沙星滴眼液.结论 结果表明,加替沙星滴眼液抗菌谱广、抗菌活性强,与氧氟沙星滴眼液疗效相当,安全性好,适于作为细菌性结膜炎的治疗用药.同时对革兰阳性菌和革兰阴性菌感染的眼表疾病,都有一定的治疗效果.

Abstract：

Objective To study the clinical efficacy of gatifloxacin eye drops for bacterial conjunctivitis.Methods A total of 240 cases that diagnosed as bacterial conjunctivitis were randomly divided into test group (gatifloxacin) and control group (floxacin).A random double-blind and paralled study was conducted on 120 cases with gatifloxacin and floxacin eye drops for bacterial conjunctivitis.The drug delivery into conjunctival sac was performed at 7-14 days (one-two drops per time, five times per day).Results Sixty-seven clinical common pathogenic bacteria were separated from the study.The antibacterial activity of gatifloxacin,floxacin, levofloxacin, ciprofloxacin was 98.51%, 85.07%, 95.52%, and 78.79% respectively.The antibacterial activity of gatifloxacin was the highest, and the statistic difference between gatifloxacin and floxacin was found.The effect of gatifloxacin eye drops was not worse than floxacin eye drops.Conclusions The gatifloxacin eye drops has characteristics with broad spectrum, powerfull antibacterial activity.The linical effect of gatifloxacin eye drops is the same with floxacin eye drops.Gatifloxacin eye drops are safe and can be used to treat bacterial conjunctivitis.It has comparatively theropic value of ocular surface disease with Gram-positive bacterial and Gram-negetive bacterial.     

0.1％溴芬酸钠滴眼液在SMILE术后的早期疗效

目的 比较0.1％溴芬酸钠滴眼液(普罗纳克滴眼液)与0.3％妥布霉素/0.1％地塞米松滴眼液(典必殊滴眼液)在SMILE术后的抗炎作用及安全性.方法 前瞻性临床对照研究.将2013年9月至2013年10月在中山大学中山眼科中心激光近视眼治疗中心接受SMILE手术的患者60例(120眼)分为2组:普罗纳克组30例和典必殊组30例.普罗纳克组术后第1天开始滴用溴芬酸钠滴眼液,每天2次,使用2周;典必殊组术后第1天开始滴用妥布霉素地塞米松滴眼液,每天4次,使用1周,作为对照.分别于术前,术后1周、1个月及3个月定期观察患者视力、屈光度、眼内压、中央角膜知觉及泪膜破裂时间(BUT)、角膜荧光染色和泪液分泌试验(Schirmer'sⅡtest)及国际眼表面疾病指数(OSDI)等干眼参数变化情况.数据采用重复测量的多因素方差分析和多重比较分析.结果 SMILE术后使用溴芬酸钠滴眼液与使用妥布霉素地塞米松滴眼液,在对术后UCVA、BCVA、角膜中央知觉、干眼参数(BUT、Schirmer'sⅡtest、OSDI)及角膜荧光染色等方面差异均无统计学意义.在SMILE术后1周时,普罗纳克组平均眼内压为(12.51 ±2.45) mmHg,明显低于典必殊组[(15.57±2.54)mmHg],差异有统计学意义(F=45.409,P＜0.05).在观察期间,普罗纳克组眼内压保持在一平稳水平,典必殊组停药后眼内压逐渐恢复.结论 SMILE术后应用0.1％溴芬酸钠滴眼液可以达到与妥布霉素地塞米松滴眼液同样的治疗效果,而相对于妥布霉素地塞米松滴眼液,溴芬酸钠滴眼液没有明显的升高眼内压作用,可作为SMILE术后一种既安全又有效的药物.     

手术切除联合自体血清滴眼液治疗翼状胬肉的疗效观察

目的:探讨手术切除联合100%浓度自体血清滴眼液治疗翼状胬肉的疗效.方法:选取2015-03/2016-03在钟祥市人民医院眼科住院确诊的120例120眼翼状胬肉患者,将其随机分为对照组和试验组.全部患者术后结膜囊内涂妥布霉素地塞米松眼膏加压包扎患眼,次日采用妥布霉素地塞米松滴眼液滴眼,6次/d,2滴/次;对照组加用聚乙烯醇滴眼液,6次/d,2滴/次;试验组加用100%浓度的自体血清滴眼液滴眼,6次/d,2滴/次.两组滴眼液每周递减2次,均治疗3 wk.术后3 mo进行手术疗效评定.结果:两组患者手术前的一般情况、眼部症状体征评分和泪液分泌试验的比较无统计学差异(P>0.05).手术后两组患者的眼部症状体征评分、角膜上皮和/或基质缺损面积及修复时间、泪液分泌试验的比较有统计学差异(P<0.05).对照组患者术后3 mo的复发率是6.7%;试验组是3.3%,两组间比较差异有统计学意义(P<0.05).结论:翼状胬肉切除联合带自体角膜缘干细胞结膜瓣移植术后辅助应用100%浓度的自体血清滴眼治疗胬肉术后创面的愈合、眼表的重建,取得了很好的疗效.     

Acute allergic reaction caused by topical azithromycin eye drops: A report of two cases

Azithromycin 1.5% ophthalmic solution (Azyter®, Thea Pharmaceuticals, Newcastle, UK) is an effective and well-tolerated option for the treatment of bacterial conjunctivitis and blepharitis, and has the advantage of a shorter treatment duration than other topical antibiotics. No acute allergic reaction has yet been reported in response to topical azithromycin eye drops. Here, we report two cases with unusual acute-type allergic reaction to topical azithromycin eye drops. A 63-year-old female patient and 67-year-old male patient treated for blepharitis with topical azithromycin 1.5% eye drops presented with epiphora, eyelid edema, chemosis, conjunctival injection, hyperemia, intensive papillary reaction, and rhinitis within 30 min of instillation. Upon cessation of the topical medication and administration of antiallergic therapy, both patients immediately showed dramatic improvement. Acute-type allergic reaction to topical azithromycin eye drops may be a rare side effect, but ophthalmologists should keep this possibility in mind and inform the patients about its potential occurrence.     

Comparative evaluation of olopatadine ophthalmic solution (0.1%) versus ketorolac ophthalmic solution (0.5%) using the provocative antigen challenge model.

OBJECTIVE: This study was conducted to compare the efficacy and safety of olopatadine ophthalmic solution (0.1%) with ketorolac ophthalmic solution (0.5%) in a clinical model of acute allergic conjunctivitis. Olopatadine is a dual acting H1 histamine receptor antagonist and a mast cell stabilizer, shown to be effective in treating allergic conjunctivitis. Ketorolac is a non-steroidal anti-inflammatory drug approved in the United States for the relief of ocular itching associated with seasonal allergic conjunctivitis. METHODS: The provocative antigen challenge model was used in this randomized, double-blind, single-center, crossover study. The allergen and concentration that consistently elicited a positive allergic reaction was used for challenge. After at least 14 days, subjects were randomized to receive either olopatadine in one eye and placebo in the contralateral eye, or ketorolac in one eye and placebo in the contralateral eye. Twenty-seven minutes after drug instillation subjects were challenged with allergen. At 3, 10, and 20 minutes following allergen challenge, subjects graded ocular itching and were assessed for hyperemia in conjunctival, ciliary, and episcleral vessel beds. Approximately 14 days later, subjects received the alternate treatment in one eye and placebo in the contralateral eye. They were again challenged with allergen and their responses were rated in the same manner. RESULTS: Olopatadine significantly (p < 0.0001) reduced both ocular itching and hyperemia in all three vessel beds compared to placebo at all time points tested following allergen challenge. Ketorolac did not significantly reduce itching and showed a trend of increased hyperemia compared to placebo. Olopatadine was significantly (p < 0.001) more effective than ketorolac in reducing hyperemia and ocular itching at all time points and was also significantly (p < 0.05) more comfortable than ketorolac as reported by subjects immediately following drug instillation. CONCLUSION: The study demonstrated that olopatadine is effective and safe in preventing and treating ocular itching and hyperemia associated with acute allergic conjunctivitis and is more effective and more comfortable than ketorolac.     

Bacteriologic and clinical efficacy of ofloxacin 0.3% versus ciprofloxacin 0.3% ophthalmic solutions in the treatment of patients with culture-positive bacterial keratitis

PURPOSE: To compare the efficacy and safety of ofloxacin 0.3% ophthalmic solution with ciprofloxacin 0.3% ophthalmic solution in patients with culture-positive bacterial keratitis. METHODS: Patients with a microbiologic diagnosis of bacterial keratitis were included in this double-masked, parallel-group study and were randomized to treatment with either ofloxacin 0.3% or ciprofloxacin 0.3% ophthalmic solution. One drop of the study medication was instilled during the daytime according to the following schedule: every half-hour on study day 1, every hour on days 2 through 4, and every 2 hours on days 5 through 21. Healing, the primary outcome measure, was defined as complete reepithelialization, accompanied by nonprogression of stromal infiltrate for 2 days. Secondary outcome measures included signs and symptoms of infection. Patients were monitored throughout the study period for any adverse events. RESULTS: A total of 217 patients completed the study: 112 were treated with ofloxacin and 105 were treated with ciprofloxacin. Streptococcus pneumoniae was the most commonly encountered pathogen in all patients. Complete corneal reepithelialization occurred in 85% of those treated with ofloxacin and in 77% of those treated with ciprofloxacin (p = 0.32). The average time to corneal ulcer healing was 13.7 days in those treated with ofloxacin and 14.4 days in those treated with ciprofloxacin. Both treatments were well tolerated with no patient discontinuing the study because of side effects. CONCLUSION: Ofloxacin 0.3% and ciprofloxacin 0.3% ophthalmic solutions are effective and safe in the treatment of patients with culture-positive bacterial keratitis.     

Effects of loteprednol/tobramycin versus dexamethasone/tobramycin on intraocular pressure in healthy volunteers

PURPOSE: To compare the steroid-induced intraocular pressure (IOP) and other ocular adverse effects of loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension with those of dexamethasone 0.1% and tobramycin 0.3% ophthalmic suspension. METHODS: Three hundred six healthy volunteers received either loteprednol etabonate/tobramycin (n = 156) or dexamethasone/tobramycin (n = 150) at 4-hour intervals 4 times a day in both eyes for 28 days in this randomized, double-masked, multicenter, parallel-group trial. IOP, visual acuity (VA), and ocular health were assessed at all study visits (days 1, 3, 8, 15, 22, and 29), whereas undilated direct ophthalmoscopy was completed at the baseline and final visits. Adverse events (AEs) were assessed at all follow-up visits. RESULTS: The number of subjects experiencing IOP increases of >or=10 mm Hg from baseline at any study visit for the loteprednol etabonate/tobramycin group (3 subjects, 1.95%) was significantly lower than that for the dexamethasone/tobramycin group (11 subjects, 7.48%; P = 0.0280), as were mean changes from baseline IOP (P < 0.05 at all visits). The lowest VA recorded for any subject at any visit was 20/40 and reductions of >or=2 lines at any visit were observed in 14 (4.55%) eyes for loteprednol etabonate/tobramycin and in 23 (7.82%) eyes for dexamethasone/tobramycin (P = 0.1257). Both treatments were well tolerated. CONCLUSIONS: Loteprednol/tobramycin was significantly less likely to produce elevations in IOP than was dexamethasone/tobramycin in healthy subjects treated for 28 days. Both loteprednol etabonate/tobramycin and dexamethasone/tobramycin were well tolerated with low risks for systemic AEs and ocular AEs other than elevation in IOP for dexamethasone/tobramycin.