Phase 3 safety comparisons for 1.0% azithromycin in polymeric mucoadhesive eye drops versus 0.3% tobramycin eye drops for bacterial conjunctivitis

PURPOSE: To compare the safety and tolerability of 1.0% azithromycin in a polymeric mucoadhesive delivery system with 0.3% tobramycin ophthalmic solution for the treatment of bacterial conjunctivitis. METHODS: This study was a prospective, randomized, active-controlled, double-masked, phase 3 trial conducted from August 6, 2004, to October 6, 2005, at 47 sites. Subjects with a clinical diagnosis of bacterial conjunctivitis were randomly assigned to receive either 1% azithromycin in DuraSite (AzaSite; InSite Vision, Alameda, CA) (n = 365) or 0.3% tobramycin (n = 378). Both groups received masked medication four times daily for 5 days, but participants received an active dose of 1% azithromycin in DuraSite only twice a day on days 1 and 2 and daily on days 3 to 5. Conjunctival cultures were taken, and ocular signs and symptoms were evaluated at baseline and at two follow-up visits. RESULTS: A total of 743 patients were randomized, and 710 (96%) completed the trial. Both study medications were well tolerated. The most frequently observed ocular adverse events in the azithromycin group were eye irritation (1.9%), conjunctival hyperemia (1.1%), and worsening bacterial conjunctivitis (1.1%). These rates compared favorably with those obtained with tobramycin. Rates of microbial eradication (an efficacy parameter) and bacterial infection recurrence (a safety parameter) were the same in both groups. CONCLUSIONS: This is the first report of the safety and tolerability of a commercially manufactured preparation of azithromycin for ophthalmic use. Azithromycin 1% in DuraSite is safe and can be administered in a regimen of less frequent doses than can tobramycin, while producing an equivalent clinical outcome. The formulation is well tolerated in patients over the age of 1 year for the eradication of bacteria commonly associated with conjunctivitis. (ClinicalTrials.gov number, NCT00105469.).     

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.     

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.     

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.     

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.     

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.     

[THIS ARTICLE HAS BEEN RETRACTED]The efficacy and safety of besifloxacin for acute bacterial conjunctivitis: a Meta-analysis

[THIS ARTICLE HAS BEEN RETRACTED] AIM: To evaluate the relative efficacy and safety of besifloxacin for treatment of acute bacterial conjunctivitis. METHODS: A comprehensive search in PubMed, EMBASE Web of Science, Cochrane Central Database and CNKI was undertaken for randomized controlled trials (RCTs) comparing besifloxacin with other treatments or placebo. The primary outcome measures were clinical resolution, rates of bacterial eradication, individual clinical outcomes, cure rates, and bacterial eradication rates of different kinds of pathogens. Safety outcomes were the number of adverse effects (AEs). The final search was performed on August 2018. RESULTS: Eight RCTs were included. Five studies compared the efficacy and safety of besifloxacin with placebo, 2 studies compared besifloxacin with moxifloxacin, and 1 study compared besifloxacin with gatifloxacin. A total of 3105 patients met the inclusion criteria. Besifloxacin presented higher efficacy and safety than did placebo in clinical resolution, rates of bacterial eradication, individual clinical outcomes, cure rates, bacterial eradication rates of different kinds of pathogens and the number of AEs. There was no significant difference between besifloxacin and moxifloxacin or gatifloxacin in the comparison items mentioned above. CONCLUSION: Besifloxacin is highly effective and safe for treatment of acute bacterial conjunctivitis. Further comparative trials regarding the effect of besifloxacin for treatment of acute bacterial conjunctivitis will aid in treatment decisions.     

Treating with besifloxacin for acute bacterial conjunctivitis: a Meta-analysis

AIM: To evaluate the relative efficacy and safety of besifloxacin for treatment of acute bacterial conjunctivitis. METHODS: A comprehensive search in PubMed, EMBASE Web of Science, Cochrane Central Database and CNKI was undertaken for randomized controlled trials (RCTs) comparing besifloxacin with other treatments or placebo. The primary outcome measures were clinical resolution, rates of bacterial eradication, individual clinical outcomes, cure rates, and bacterial eradication rates of different kinds of pathogens. Safety outcomes were the number of adverse effects (AEs). The final search was performed on August 2018. RESULTS: Six RCTs were included. Four studies compared the efficacy and safety of besifloxacin with placebo, 1 study compared besifloxacin with moxifloxacin, and 1 study compared besifloxacin with gatifloxacin. A total of 2780 patients met the inclusion criteria. Besifloxacin presented higher efficacy and safety than did placebo in clinical resolution, rates of bacterial eradication, individual clinical outcomes, cure rates, bacterial eradication rates of different kinds of pathogens and the number of AEs. There was no significant difference between besifloxacin and moxifloxacin or gatifloxacin in the comparison items mentioned above. CONCLUSION: Besifloxacin is highly effective and safe for treatment of acute bacterial conjunctivitis. Further comparative trials regarding the effect of besifloxacin for treatment of acute bacterial conjunctivitis will aid in treatment decisions.     

A controlled trial of povidone-iodine to treat infectious conjunctivitis in children

PURPOSE: To report the efficacy of povidone-iodine as a treatment for conjunctivitis in pediatric patients. DESIGN: Double-masked, controlled, prospective clinical trial. METHODS: In an ophthalmology clinic in a general hospital in Manila, Philippines, 459 children (mean [SD] age 6.6 [6.6] years; range, 7 months-21 years) with acute conjunctivitis were studied. Infected eyes were cultured for bacteria and underwent immunofluorescent testing for Chlamydia trachomatis. Viral conjunctivitis was diagnosed if bacterial cultures were negative and diagnostic criteria were met. Subjects were alternated to receive povidone-iodine 1.25% or neomycin-polymyxin-B-gramicidin ophthalmic solution, one drop 4 times daily in the affected eye. Ocular inflammation was evaluated daily by the family or patient and weekly by an ophthalmologist. The main outcome measures were days until cured and proportion cured after 1 and 2 weeks of treatment. RESULTS: Despite adequate statistical power (power >80% for a 1-day difference and P <.05), there was no significant difference between treatment groups regarding the number of days to cure or proportion cured at 1 or 2 weeks whether caused by bacteria or virus (P =.133-.824 for the four comparisons). After 1 week of treatment, povidone-iodine cured marginally more chlamydial infections than the antibiotic (P =.057). By 2 weeks, fewer chlamydial infections were cured than those of viral or bacterial etiology (P =.0001). The younger the patient, the faster their conjunctivitis resolved (R = 0.13, P =.013). CONCLUSIONS: Povidone-iodine 1.25% ophthalmic solution was as effective as neomycin-polymyxin B-gramicidin for treating bacterial conjunctivitis, somewhat more effective against chlamydia, and as ineffective against viral conjunctivitis. Povidone-iodine ophthalmic solution should be strongly considered as treatment for bacterial and chlamydial conjunctivitis, especially in developing countries where topical antibiotics are often unavailable or costly.     

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.     

Azithromycin vs doxycycline in the treatment of inclusion conjunctivitis

PURPOSE: The aim of the study was to compare the efficacy and safety of azithromycin and doxycycline in the treatment of chlamydial conjunctivitis in adults. DESIGN: An open, randomized clinical trial. METHODS: Seventy-eight adult patients with incluson conjunctivitis were enrolled in this multicenter clinical study. Patients with chlamydial conjunctivitis as indicated by a positive direct fluorescent antibody (DFA) test or cell culture were randomized to receive a single 1-g dose of azithromycin or doxycycline, 100 mg twice daily for 10 days. A conjuctival swab for cell culture was obtained from all patients immediately before the treatment for subsequent confirmation of the presence of chlamydial infection in the central laboratory. Control examinations were performed 10 to 12 days and 4 to 6 weeks after the treatment initiation. Clinical and bacteriological responses to the treatment were evaluated at the last visit. The occurrence and frequency of adverse events were analyzed as well. RESULTS: Of 78 patients enrolled, 51 completed the study and were evaluated for efficacy. The main reasons for withdrawal were lack of confirmation of the presence of chlamydial infection by the central laboratory and failure to attend the follow-up visit. Eradication of C. trachomatis was achieved in 23 of 25 (92%) patients treated with azithromycin and in 25 of 26 (96%) patients treated with doxycycline. Clinical cure was observed in 15 (60%) and 18 (69%) patients treated with azithromycin and doxycycline, respectively. Both drugs were equally well tolerated. CONCLUSIONS: A single 1-g azithromycin therapy was as effective as standard 10-day treatment with doxycycline (100 mg twice daily) in the treatment of adult inclusion conjunctivitis.     

Efficacy and safety of ketotifen eye drops in the treatment of seasonal allergic conjunctivitis

BACKGROUND: Ketotifen blocks histamine H(1) receptors, stabilises mast cells, and prevents eosinophil accumulation. These multiple, pharmacological mechanisms provided the rationale for assessing the efficacy and safety of ketotifen 0.025% eye drops in subjects with seasonal allergic conjunctivitis (SAC) in an environmental setting. METHODS: This was a double masked, randomised, multicentre trial conducted in Australia. Subjects were randomly assigned to ketotifen fumarate 0.025% ophthalmic solution, placebo (as vehicle), or levocabastine hydrochloride 0.05% ophthalmic suspension, twice daily in each eye for a 4 week period. Subjects were assessed at follow up (days 5-8) and termination (days 25-31) visits. The primary efficacy variable was the responder rate, based on the subjects' assessment of global efficacy at the follow up visit. RESULTS: 519 subjects were randomised to treatment. At the follow up visit, the responder rate, based on subjects' assessment of global efficacy, was significantly greater in the ketotifen group (49.5%) than in the placebo group (33.0%) for subjects with a positive diagnostic test for pollen allergy (p = 0.02). The investigators' assessment of responder rates also showed that ketotifen was superior to placebo (p = 0.001). Ketotifen produced a significantly better outcome than levocabastine (p<0.05) for relief of signs and symptoms of SAC, at both the follow up and the termination visit. The type and frequency of adverse events were similar across treatment groups. CONCLUSIONS: In an environmental setting, ketotifen fumarate 0.025% ophthalmic solution was well tolerated and effective in reducing the signs and symptoms of SAC, and in preventing their recurrence. Ketotifen consistently showed the best efficacy in comparison with both placebo and levocabastine. These results indicate that ketotifen eye drops are a valuable treatment option for this condition.     

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.     

Comparative analysis of safety and efficacy of Alcaftadine 0.25%, Olopatadine hydrochloride 0.2% and Bepotastine besilate 1.5% in allergic conjunctivitis

Purpose:To compare the efficacy and safety of Alcaftadine 0.25%, Olopatadine hydrochloride 0.2%, and Bepotastine besilate 1.5% ophthalmic solutions in the treatment of allergic conjunctivitis.Methods:This is a prospective, observer-masked, comparative study of 180 patients with mild to moderate allergic conjunctivitis, randomized into three groups of 60 patients each. Each group was assigned to be treated with one of the three treatment options namely Alcaftadine 0.25%, Olopatadine hydrochloride 0.2% and Bepotastine besilate 1.5% ophthalmic solutions. Patients were followed-up at regular intervals with relief and resolution of symptoms and signs noted using Total Ocular Scoring System (TOSS) and hyperaemia scale.Results:All three topical medications were effective in resolving symptoms of the patients with mild to moderate allergic conjunctivitis. Baseline mean TOSS scores for Alcaftadine group, Olopatadine group and Bepotastine besilate group were (7.68±2.32), (7.65±2.32) and (7.45±2.27) respectively as compared to the corresponding TOSS scores on 14^th Day (4^th visit) which were (0.2 ± 0.43), (0.4 ± 0.56) and (0.1 ± 0.36) respectively. The resolution of symptoms in the Bepotastine and Alcaftadine groups was significantly profound as compared to the Olopatadine group (p = 0.008). Bepotastine and Alcaftadine groups significantly reduced allergic conjunctivitis symptoms compared to Olopatadine group (p = 0.008).Conclusion:All three topical ophthalmic medications used in the study are safe and effective in the treatment of allergic conjunctivitis. However, Bepotastine and Alcaftadine appear to outweigh Olopatadine in resolving the symptoms of allergic conjunctivitis.     

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。     

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.     

急性细菌性结膜炎最新病原学分析

目的　探讨我国最新急性细菌性结膜炎致病菌的种类。方法　对５０例（５０眼）急性细菌性结膜炎患者结膜囊分泌物进行细菌学检查,给予患者１０ｇ·Ｌ－１阿奇霉素滴眼液滴眼,每天２次,滴眼２ｄ后改为每天１次,治疗３ｄ,于第８天再次行细菌培养检查。结果　急性细菌性结膜炎结膜囊分泌物细菌培养阳性率８０．０％,革兰阳性细菌占９７．５％,表皮葡萄球菌占首位（占培养阳性总数７２．５％）,其中包括２例苯唑西林耐药表皮葡萄球菌。应用抗生素治疗后,４７例（９４．０％）患者临床症状缓解。再次行病原学检查,原致病菌全部清除率为６０．０％,部分清除率为５．０％。治疗后细菌培养仍阳性细菌主要为表皮葡萄球菌（占培养阳性总数５６．２％）。结论　表皮葡萄球菌已成为我国目前急性细菌性结膜炎的首要致病菌,在临床工作中应对其予以重视,选择针对性治疗。     

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.     

Safety and efficacy of ketorolac tromethamine 0.4% ophthalmic solution in post-photorefractive keratectomy patients

PURPOSE: To evaluate the safety and analgesic efficacy of ketorolac tromethamine 0.4% ophthalmic solution in postoperative photorefractive keratectomy (PRK) patients. SETTING: Fifteen clinical sites in the eastern and southern United States. METHODS: This pooled analysis of 2 multicenter, randomized, double-masked, vehicle-controlled, parallel-group studies comprised 313 patients having unilateral PRK. After surgery, patients were treated with 1 drop of ketorolac tromethamine 0.4% ophthalmic solution (Acular(R) LS) (n = 156) or vehicle (n = 157) 4 times daily for up to 4 days. Pain intensity, pain relief, use of escape medication, and severity of ocular symptoms were assessed. Adverse events, epithelial healing, and visual acuity were recorded. RESULTS: There was significantly less pain intensity experienced by patients in the ketorolac group (P<.001). During the first 12 hours post PRK, 50% fewer patients in the ketorolac group than in the vehicle group had severe to intolerable pain (41.6% [64/154] and 84.5% [131/155], respectively). The median time to no pain was 30 hours in the ketorolac group and 54 hours in the vehicle group (P<.001, survival analysis). Ketorolac patients reported significantly greater pain relief than vehicle patients throughout the study (P<.001). Ketorolac patients used significantly less escape medication than vehicle patients for 48 hours post PRK (P< or =.008). Treatment-related adverse events occurred in 2.6% (4/156) of ketorolac patients and 6.4% (10/157) of vehicle patients. CONCLUSION: Ketorolac 0.4% ophthalmic solution is safe and effective in reducing ocular pain when used 4 times daily for up to 4 days post PRK.     

Efficacy and safety of topical oxymetazoline in treating allergic and environmental conjunctivitis

This randomized, double-masked study evaluated the safety and efficacy of oxymetazoline 0.025% topical ophthalmic solution compared with its vehicle when used to treat allergic or environmental conjunctivitis. Thirty-nine patients with moderate bilateral conjunctival hyperemia instilled one drop of either oxymetazoline 0.025% solution or its vehicle twice daily for one week. At each evaluation the signs and symptoms of conjunctivitis were evaluated, complete eye examinations were performed, and heart rate and blood pressure were measured. An overall assessment of treatment efficacy was made at each follow-up evaluation. The signs and symptoms of conjunctivitis had significantly improved in the oxymetazoline-treated group when compared with those of the vehicle-treated group, and the ocular and systemic safety of each treatment was comparable.