Efficacy and safety of nedocromil sodium ophthalmic solution in the treatment of seasonal allergic conjunctivitis.

To assess the efficacy and safety of twice-daily administration of nedocromil sodium 2% ophthalmic solution, we performed a multicenter study involving 140 patients with seasonal allergic conjunctivitis. Subjects had a history of seasonal allergic conjunctivitis and positive results of a skin test to ragweed. The trial coincided with the peak ragweed pollen season at five treatment centers. Patients treated with nedocromil sodium had improvements in symptoms with statistically significant reductions recorded for eye itching (P less than or equal to .04), conjunctival injection (P less than or equal to .001), and overall disease severity (P less than or equal to .001) as compared to the placebo-treated group. Adverse events were minor and transient. We concluded that nedocromil sodium 2% ophthalmic solution administered twice daily is effective in relieving major symptoms associated with seasonal allergic conjunctivitis.     

Nedocromil sodium treats symptoms of perennial allergic conjunctivitis not fully controlled by sodium cromoglycate A double-masked placebo controlled group comparative study

In a double-masked group comparative study, 20 patients received 2% nedocromil sodium four times daily and 23 placebo eye drops, for treatment of perennial allergic conjunctivitis (PAC). All had at least a one-year diagnosis of bilateral PAC and remained symptomatic despite using 2% sodium cromoglycate eye drops four times daily for at least 14 days Symptom severity (0-4) during sodium cromoglycate monotherapy was then recorded in a one-week baseline prior to randomisation, a minimum total score of 11 being mandatory. During the trial, no eye medication was allowed other than the test treatment. Clinic examinations were made before and after baseline and after one, three and six weeks' treatment, and patients kept daily diary cards of eye symptom severity. Compared to placebo, nedocromil sodium significantly (p<0.05) improved diary scores for itching (weeks 3, 4, 5, 6), total symptoms (weeks 5, 6) and general eye condition (week 6). Mean scores over the final four weeks, allowing a two-week washout, showed similar improvements in itching (p = 0.01), total symptoms (p = 0.05) and general eye condition (p = 0.04). Clinical assessments again favoured nedocromil sodium, which improved itching (week 3, p = 0.002), burning (week 6, p = 0.007), overall eye condition (weeks 3-6, p<0.05). and conjunctival thickening and hyperaemia (weeks 3-6, p<0.05). Finally, both patient (p = 0.02) and clinician (p = 0.0015) opinions of efficacy favoured nedocromil sodium over placebo. These results show nedocromil sodium to be effective in controlling symptoms of perennial allergic conjunctivitis which persisted during treatment with sodium cromoglycate.     

Supplementation of fexofenadine therapy with nedocromil sodium 2% ophthalmic solution to treat ocular symptoms of seasonal allergic conjunctivitis

Purpose: Ocular symptoms are often under‐treated in patients with allergic rhinoconjunctivitis. The efficacy of fexofenadine hydrochloride 60 mg capsules supplemented with nedocromil sodium 2% ophthalmic solution was evaluated to determine the optimal drug regimen for control of ocular allergic symptoms. Methods: In this 5‐week, open‐label, randomized, multicentre comparative study, 89 patients with documented ragweed pollen allergy received fexofenadine b.i.d. with nedocromil rescue, fexofenadine q.d. with nedocromil b.i.d., or fexofenadine rescue with nedocromil b.i.d. during the ragweed pollen season. Results: For all regimens, mean symptom severity scores for itching, burning, tearing, redness, grittiness, discharge, light sensitivity and swelling improved significantly (P < 0.003). Similarly, all groups experienced significant (P < 0.02) improvement in all clinical signs: erythema, oedema, discharge, conjunctival injection and conjunctivitis, as well as quality‐of‐life scores (P < 0.0001). All regimens reduced overall symptom severity scores after 5 min (P < 0.05) with relief persisting over 12 h (P < 0.03). Improvements in mean symptoms, signs and quality‐of‐life scores were similar among the treatment groups as were onset and duration of action even though patients in two of the three study arms were taking one‐half or less of the recommended fexofenadine dosage. Patients and physicians judged the regimens containing lower fexofenadine dosages (with nedocromil b.i.d.) to be more effective overall than the regimen containing the highest fexo­fenadine dosage (with nedocromil as rescue only). Conclusions: Supplementation of oral fexofenadine therapy with nedocromil sodium 2% ophthalmic solution relieves ocular symptoms of seasonal allergic rhinoconjunctivitis, allowing control of rhinal symptoms with half the recommended dosage of fexofenadine.     

Studies comparing the efficacy of nedocromil sodium eye drops with sodium cromoglycate and placebo in seasonal allergic conjunctivitis

Two multicentre, double-blind, placebo controlled group comparative studies were carried out in Finland, during the birch pollen seasons of 1987 and 1989, to compare the efficacy and tolerability of 2% nedocromil sodium eye drops (twice daily) with either 2% sodium cromoglycate eye drops (four times daily) and/or placebo, in patients with seasonal allergic conjunctivitis. Study 1 compared nedocromil sodium (64 patients) with placebo (62 patients) and showed that the opinions of treatment efficacy of both patients and clinicians were significantly in favour of nedocromil sodium (p = 0.003, patients; p = 0.006, clinicians). In addition, the placebo group used significantly more topical (p<0.05) and oral (p<0.01) concomitant antihistamine therapy. Diary card scores and clinical assessments showed trends for active treatment. Study 2 compared nedocromil sodium (60 patients) with sodium cromoglycate (61) and placebo (64). Symptomatology was low, in general, but patient diary card scores showed significant control of itching by both active treatments. Clinical assessments also showed some improvement with both active treatments, reaching statistical significance for grittiness and photophobia. Overall opinions demonstrated a high placebo effect. At the end of the trial, full or moderate control of symptoms was reported by 80% of patients (73% clinicians) receiving nedocromil sodium, 75% of patients (74% clinicians) receiving sodium cromoglycate and 73% of patients (69% clinicians) receiving placebo. Taken as a whole, these results suggest that twice-daily nedocromil sodium eye drops are as efficacious as four times daily sodium cromoglycate eye drops in controlling seasonal allergic conjunctivitis.     

Comparison of emedastine 0.05% or nedocromil sodium 2% eye drops and placebo in controlling local reactions in subjects with allergic conjunctivitis

PURPOSE: To assess the efficacy of nedocromil sodium 2% eye drops and emedastine difumarate 0.05% eye drops in controlling the ocular allergic reaction induced by conjunctival allergen challenge (CAC). METHODS: Thirty subjects with a personal history of allergic conjunctivitis were enrolled (first visit). At the second visit each subject randomly received emedastine 0.05% or nedocromil 2% in one eye and placebo in the other eye. Five minutes after the medication the offending allergen was instilled in both eyes. Ocular redness and itching were evaluated according to a standardized scoring system at 3, 10 and 20-minute intervals after instillation of the allergen. After one week (third visit) the whole procedure was repeated using the placebo in the eye used as control during second visit and one of the trial drug that was not used at second visit in the other eye (either emedastine or nedocromil). RESULTS: Emedastine 0.05% and nedocromil 2% eye drops were more effective than placebo in controlling ocular redness and itching (p<0.01). Emedastine was more effective (p<0.01) than nedocromil in alleviating redness and itching 3 and 10 minutes after application of the allergen. CONCLUSIONS: Emedastine 0.05% appeared superior to nedocromil 2% in producing immediate relief when subjects with allergic conjunctivitis were exposed to the offending allergen.     

Nedocromil sodium and astemizole,alone or combined,for treatment of seasonal allergic conjunctivitis (SAC)

SAC is caused by allergen interaction with IgE antibody on conjunctival mast cells, leading to local release of vasoactive inflammatory mediators such as histamine. Nedocromil sodium both stabilizes mast cells and has antiinflammatory activity against other cells involved in allergic inflammation. Astemizole is a second generation orally-active H₁-receptor antagonist with reduced CNS effects such as drowsiness. This multicentre, double blind, double dummy trial compared efficacy and safety of qid 2% nedocromil sodium eye drops with once daily 10 mg oral astemizole, placebo, and combined active treatments for a four-week period. SAC patients (n=207, aged 6-70 years) recorded their symptoms each day on diary cards. Signs and symptoms were also evaluated by clinicians after one, two and four weeks and overall opinions were recorded at the end of treatment. Nedocromil sodium eye drops and astemizole, alone or combined, significantly reduced ocular symptoms compared to placebo (for diary card total symptom score and patients' opinion). Clinicians' opinion showed significantly decreased symptoms with nedocromil sodium, alone or combined, but not with astemizole alone. All treatments were well tolerated, with drowsiness the most frequent side effect observed in patients treated with astemizole. These results demonstrate the effectiveness of nedocromil sodium eye drops in the treatment of SAC.     

Treatment of ragweed pollen seasonal allergic conjunctivitis (SAC) with b.i.d. nedocromil sodium 2% ophthalmic solution

An eight-week multicenter double-masked placebo-controlled group comparison was carried out in 86 patients (age 13-60 years) to determine efficacy and safety of b.i.d. nedocromil sodium 2% ophthalmic solution in ragweed SAC. Treatment was timed to coincide with the predicted ragweed pollen season, taking the two to three weeks of peak pollen counts as the period for analysis. Clinical efficacy was measured from group mean symptom scores (0-4 scale of severity) recorded by the patients on daily diary cards, and the results of clinic examinations made before and after a one-week baseline and following one, three, five and eight weeks of treatment. During the peak pollen season, use of nedocromil sodium reduced all symptoms, with statistically significant differences from placebo, for itching, tearing/watering, overall eye condition and the total symptom summary score (itching+tearing+burning). Clinical assessments of nedocromil sodium showed significant relief of tearing, conjunctival injection and edema. Overall opinions also demonstrated significant benefit with nedocromil sodium, 61% of patients rating active treatment at least moderately effective compared with 36% for placebo (clinicians' opinions were respectively 46% vs 21%). Nedocromil sodium 2% ophthalmic solution b.i.d. caused no major side-effects and was more effective than placebo in relieving major symptoms of SAC.     

Treatment of ragweed pollen seasonal allergic conjunctivitis (SAC) with b.i.d. nedocromil sodium 2% ophthalmic solution

An eight-week multicenter double-masked placebo-controlled group comparison was carried out in 86 patients (age 13-60 years) to determine efficacy and safety of b.i.d. nedocromil sodium 2% ophthalmic solution in ragweed SAC. Treatment was timed to coincide with the predicted ragweed pollen season, taking the two to three weeks of peak pollen counts as the period for analysis. Clinical efficacy was measured from group mean symptom scores (0-4 scale of severity) recorded by the patients on daily diary cards, and the results of clinic examinations made before and after a one-week baseline and following one, three, five and eight weeks of treatment. During the peak pollen season, use of nedocromil sodium reduced all symptoms, with statistically significant differences from placebo, for itching, tearing/watering, overall eye condition and the total symptom summary score (itching+tearing+burning). Clinical assessments of nedocromil sodium showed significant relief of tearing, conjunctival injection and edema. Overall opinions also demonstrated significant benefit with nedocromil sodium, 61% of patients rating active treatment at least moderately effective compared with 36% for placebo (clinicians' opinions were respectively 46% vs 21%). Nedocromil sodium 2% ophthalmic solution b.i.d. caused no major side-effects and was more effective than placebo in relieving major symptoms of SAC.     

Nedocromil sodium and astemizole, alone or combined, for treatment of seasonal allergic conjunctivitis (SAC)

SAC is caused by allergen interaction with IgE antibody on conjunctival mast cells, leading to local release of vasoactive inflammatory mediators such as histamine. Nedocromil sodium both stabilizes mast cells and has antiinflammatory activity against other cells involved in allergic inflammation. Astemizole is a second generation orally-active H(1)-receptor antagonist with reduced CNS effects such as drowsiness. This multicentre, double blind, double dummy trial compared efficacy and safety of qid 2% nedocromil sodium eye drops with once daily 10 mg oral astemizole, placebo, and combined active treatments for a four-week period. SAC patients (n=207, aged 6-70 years) recorded their symptoms each day on diary cards. Signs and symptoms were also evaluated by clinicians after one, two and four weeks and overall opinions were recorded at the end of treatment. Nedocromil sodium eye drops and astemizole, alone or combined, significantly reduced ocular symptoms compared to placebo (for diary card total symptom score and patients' opinion). Clinicians' opinion showed significantly decreased symptoms with nedocromil sodium, alone or combined, but not with astemizole alone. All treatments were well tolerated, with drowsiness the most frequent side effect observed in patients treated with astemizole. These results demonstrate the effectiveness of nedocromil sodium eye drops in the treatment of SAC.     

Nedocromil sodium 2% ophthalmic solution (TilavistTM) A new topical treatment for ocular allergic inflammation

Nedocromil sodium, a non-toxic pyranoquinoline dicarboxylate, was developed as a novel topical treatment for allergic inflammatory lung diseases. With a broader pharmacological potential than the chromone compound sodium cromoglycate, nedocromil sodium has more potent antiinflammatory effects whilst maintaining a good safety profile due to rapid excretion, unmetabolized. Having the ability to stabilize both mucosal (MC_T) and connective tissue (MC_TC) mast cells and directly to inhibit activated cells such as eosinophils, which are involved in continuing allergic inflammation in the eye as well as in the airways, nedocromil sodium appears ideally suited to the treatment of allergic conjunctivitis. Preliminary therapeutic trials have confirmed efficacy and the lack of side-effects of the 2% eye drop formulation of nedocromil sodium, and its comparative potency which permits twice-daily administration for seasonal ocular symptoms, with the safe option of increasing to four times daily use for more severe, chronic allergic inflammatory conditions. With many patients already symptomatic at the start of trial treatment, nedocromil sodium eye drops have also proved to have a rapid onset of action providing relief of symptoms in 24 hours in the majority of cases, and often within one hour of the first dose.     

A randomized,double-masked,placebo-controlled parallel study of loteprednol etabonate 0.2% in patients with seasonal allergic conjunctivitis

ObjectiveTo evaluate the effects of loteprednol etabonate (LE) 0.2% in reducing the signs and symptoms of seasonal allergic conjunctivitis.DesignRandomized, double-masked, placebo-controlled, parallel group multicenter study of 6 weeks duration.ParticipantsA total of 135 patients with signs and symptoms of seasonal allergic conjunctivitis participated.InterventionAll patients received either LE 0.2% or placebo (vehicle) four times a day in both eyes for 42 days.Main outcome measuresBulbar conjunctival injection (primary sign) and itching (primary symptom) over the first 2 weeks of treatment was measured.ResultsA reduction in severity was seen in both LE and placebo groups for bulbar conjunctival injection (1.5 vs. 1.0 units on a 0–3 scale) and itching (3.4 vs. 3.0 units on a 0–4 scale) over the first 2 weeks. The treatment effect by these measures was −0.5 and −0.4 units in favor of LE (P ≤ 0.008). Resolution (i.e., the proportion of patients with signs or symptoms no longer present) at day 14 strongly favored LE-treated patients (36% and 15%; 58% and 38%, for injection and itching, respectively).Both treatments were well tolerated. One patient in each treatment group (1 of 67 and 1 of 68, respectively) had an elevation of intraocular pressure of 10 mmHg or greater during the 6 weeks of treatment.ConclusionsLoteprednol etabonate 0.2% was more effective than placebo in the treatment of seasonal allergic conjunctivitis. Loteprednol etabonate 0.2% had a safety profile comparable to placebo.     

A double blind placebo controlled group comparative study of ophthalmic sodium cromoglycate and nedocromil sodium in the treatment of vernal keratoconjunctivitis.

In a 4 week double masked comparative study, patients received 2% nedocromil sodium (48), 2% sodium cromoglycate (48), or placebo eye drops (42), four times daily, for the treatment of vernal keratoconjunctivitis (VKC). Clinical examinations of eye condition and symptom severity were made before and after a 1 week baseline before starting test treatment, and after 1, 2, and 4 weeks of treatment. Patients kept daily diary card records of symptom severity and concomitant therapy. At the clinic, significant improvements were seen with both active treatments after 2-4 weeks. During the final visit, significant benefits over placebo were recorded for five ocular signs with nedocromil sodium and three with sodium cromoglycate, bulbar and lower tarsal chemosis being better controlled by nedocromil sodium (p < 0.05 v sodium cromoglycate). Diary card trends showed improvement with all three treatments, which was greatest with nedocromil sodium and least with placebo. Compared with placebo, both the active drugs produced statistically significant improvements in general eye condition during weeks 1-2, and nedocromil sodium significantly reduced itching within the first week. Overall, nedocromil sodium had the greatest effect on symptoms, although diary card data revealed no statistically significant differences between the two active drugs. In conclusion, both 2% nedocromil sodium and 2% sodium cromoglycate were effective in controlling VKC when administered four times daily into the eyes, while the marked anti-inflammatory activity of nedocromil sodium was apparent in its more pronounced overall therapeutic effect.     

Nedocromil sodium 2% ophthalmic solution (Tilavist(TM)) A new topical treatment for ocular allergic inflammation

Nedocromil sodium, a non-toxic pyranoquinoline dicarboxylate, was developed as a novel topical treatment for allergic inflammatory lung diseases. With a broader pharmacological potential than the chromone compound sodium cromoglycate, nedocromil sodium has more potent antiinflammatory effects whilst maintaining a good safety profile due to rapid excretion, unmetabolized. Having the ability to stabilize both mucosal (MC(T)) and connective tissue (MC(TC)) mast cells and directly to inhibit activated cells such as eosinophils, which are involved in continuing allergic inflammation in the eye as well as in the airways, nedocromil sodium appears ideally suited to the treatment of allergic conjunctivitis. Preliminary therapeutic trials have confirmed efficacy and the lack of side-effects of the 2% eye drop formulation of nedocromil sodium, and its comparative potency which permits twice-daily administration for seasonal ocular symptoms, with the safe option of increasing to four times daily use for more severe, chronic allergic inflammatory conditions. With many patients already symptomatic at the start of trial treatment, nedocromil sodium eye drops have also proved to have a rapid onset of action providing relief of symptoms in 24 hours in the majority of cases, and often within one hour of the first dose.     

Topical non-steroidal anti-inflammatory drugs in allergic conjunctivitis: meta-analysis of randomized trial data

PURPOSE: To assess the effect of topical Non-Steroidal Anti Inflammatory drugs in the treatment of allergic conjunctivitis. METHOD: Systematic Review. Data Sources and study selection: Reports of comparative randomized trials of topical NSAIDs and placebo identified by searches of Medline, Embase, the Cochrane Register of Controlled Trials. Data extraction and synthesis: Two reviewers assessed trials for eligibility and quality and extracted data independently. Data were synthesized (random effects model) and results expressed results for dichotomous outcomes as relative risk and continuous outcomes as weighted mean difference. Sensitivity analysis was used to examine potential heterogeneity by differences in study quality. RESULTS: Eight studies incorporating 712 patients were included. The difference between the decrease in allergic sign and symptom score for NSAID treatment compared to placebo was between 4 and 19 percentage points. Topical NSAIDs produced significantly greater relief for conjunctival itching (cardinal symptom) than did placebo (combined standardized mean difference -0.54 (p < 0.001; 95% confidence interval -0.84 to -0.24). The results for the other allergic symptoms: ocular burning/pain, eyelid swelling, photophobia and foreign sensation were not significant. Topical NSAIDs produced significantly greater reduction of conjunctival injection than did placebo (combined standardized mean difference -0.51 (p = 0.03; 95% confidence interval -0.97 to -0.05). Topical NSAIDs did not reduce the allergic signs of conjunctival chemosis, conjunctival mucus, eyelid swelling and corneal disturbance. Topical NSAIDs had a significantly higher rate of burning/stinging on application of medication compared to placebo (P < 0.0001; odds ratio 3.97 (95% CI 2.67 to 5.89). CONCLUSION: This meta-analysis confirms that topical NSAID are significantly more effective at relieving the cardinal symptom: conjunctival itching and improving the cardinal sign: conjunctival injection than placebo treatment. A systematic review comparing topical NSAIDs to topical antihistamines/mast cell stabilizers in treatment of allergic conjunctivitis is warranted as this will compare the topical NSAIDs to current therapeutic guidelines.     

Evaluation of topical cromolyn sodium in the treatment of vernal keratoconjunctivitis

A randomized, double-masked, placebo-controlled multicenter study was conducted for 6 weeks in 12 centers to evaluate the efficacy and safety of cromolyn sodium 4% ophthalmic solution (Opticrom) for the treatment of active bilateral vernal conjunctivitis. Objective clinical signs were graded weekly by an ophthalmologist while patients kept a daily record of the severity of their symptoms. Sixty-five patients completed the study; 35 received cromolyn sodium and 30 were treated with a matching placebo (the drug vehicle). Statistically significant differences in favor of cromolyn sodium treatment were found for conjunctival injection, limbal injection, limbal edema, tearing, and symptoms summary score. There were few side effects (usually mild stinging and burning which did not require drug stoppage). Only one patient required drug discontinuation for possible drug- or vehicle-related side effects. Cromolyn sodium was found to be significantly more effective than placebo in treating the signs and symptoms of vernal keratoconjunctivitis (VKC). When results were stratified in terms of the atopic status of the patient, it was clear that the allergic patients responded better to cromolyn sodium than did those in whom allergic (IgE-mediated) factors appeared unimportant in the disease process.     

Efficacy of olopatadine HCI 0.1%, ketotifen fumarate 0.025%, epinastine HCI 0.05%, emedastine 0.05% and fluorometholone acetate 0.1% ophthalmic solutions for seasonal allergic conjunctivitis: a placebo‐controlled environmental trial

Purpose: We aimed to compare the clinical efficacy and ocular surface variables of olopatadine, ketotifen fumarate, epinastine, emedastine and fluorometholone acetate ophthalmic solutions in preventing the signs and symptoms of seasonal allergic conjunctivitis (SAC). Methods: This was a prospective, randomized, double‐blinded and placebo‐controlled study. A total of 100 patients with SAC were randomly assigned to one of five groups, in which they were administered olopatadine, ketotifen fumarate, epinastine, emedastine or fluorometholone acetate, instilled twice daily for 2 weeks. One eye of each patient was treated with the study drug and the other was treated with a placebo. Signs and symptoms of allergic conjunctivitis (itching, redness, tearing, chemosis and eyelid swelling) were scored on a 4‐point scale. Each symptom was assessed at baseline and then again after 1 and 2 weeks of treatment. Ocular surface variables were assessed by conjunctival impression cytology. Results: At weeks 1 and 2, all antiallergic agents were significantly more effective than placebo in alleviating itching, redness, tearing, chemosis and eyelid swelling. Fluorometholone acetate was significantly less effective than the other agents in reducing itching and redness at all control visits. Ocular surface findings by impression cytology improved significantly after all treatments compared with placebo. Conclusions: In patients with SAC, olopatadine, ketotifen, epinastine and emedastine are more efficacious than fluorometholone acetate in preventing itching and redness. All the antiallergic agents gave similar results in terms of reducing tearing, chemosis and eyelid swelling. Our data showed that impression cytology parameters improved after treatment with antiallergic agents in patients with SAC.     

富马酸酮替芬滴眼液治疗季节变应性结膜炎眼痒及结膜充血的疗效观察

目的 探讨0.025%富马酸酮替芬滴眼液治疗季节性变应性结膜炎患者眼痒、结膜充血的临床疗效.方法 采用多中心、双盲、随机、平行组别的研究方法,将诊断为季节性变应性结膜炎的229例(229只眼)患者随机分为试验组114例,给予进口0.025%富马酸酮替芬滴眼液,对照组115例,给予0.05%依美斯汀滴眼液,均为2次/d,每次1滴,疗程14d.在用药前和用药后(7±1)d,(14±1)d对两组患者的眼痒和结膜充血进行观察评分.结果 用药后(7±1)d以及(14±1)d,酮替芬组和依美斯汀组眼痒、结膜充血评分均明显下降,与基线期相比差异有统计学意义(P＜0.05);眼痒和结膜充血下降幅度组间(酮替芬一依美斯汀)差异无统计学意义(P＞0.05).结论 进口0.025%富马酸酮替芬滴眼液治疗季节性变应性结膜炎患者的眼痒、结膜充血疗效非劣效于0.05%依美斯汀滴眼液.     

Efficacy and safety of desonide phosphate for the treatment of allergic conjunctivitis

PURPOSE: To study the safety and efficacy of the topical corticosteroid, desonide 0.25% ophthalmic solution, for inhibition of the clinical allergic reaction induced by conjunctival provocation (CPT) and for the treatment of seasonal allergic conjunctivitis (SAC). METHODS: For the CPT study, 12 allergic but inactive patients were exposed in both eyes to increasing doses of a specific allergen until a positive bilateral, symmetrical early- and late-phase reaction was obtained. After 2 weeks the last positive dose was readministrated and their positive response confirmed. After an additional 2 weeks, CPT was performed 30 minutes after topical administration of desonide in one eye and placebo in the contralateral eye (Group A) or after topical desonide or placebo four times a day for 2 days (Group B). Clinical signs and symptoms were recorded after 15, 30, and 60 minutes, and after 6 hours. Regarding the seasonal study, 96 patients with active SAC were treated bilaterally with either desonide or fluorometholone for 3 weeks, and allergic signs and symptoms evaluated at regular intervals. The safety of the drugs was assessed by identification of any side effects or adverse events of any kind. RESULTS: For the CPT study: individual itching and redness, and the sum score for signs and symptoms were all statistically (p < 0.05) and clinically (greater than 1 change between treated eyes) significantly lower in desonide versus placebo eyes. Both early- and late-phase reactions were reduced by desonide pretreatment. Seasonal study: desonide and fluorometholone were both highly effective in reducing itching, tearing, and conjunctival hyperemia over time (p < 0.0001). Both drugs appeared safe, with no statistically significant changes in IOP observed with either treatment. CONCLUSIONS: Desonide has a significant therapeutic effect on both the induced conjunctival early- and late-allergic reaction and in active SAC. It was also safe, with no side effects such as increases in intraocular pressure observed by physician or patient.     

氯雷他定联合双氯芬酸钠滴眼液治疗过敏性结膜炎临床研究

目的：：探讨氯雷他定联合双氯芬酸钠滴眼液治疗过敏性结膜炎的临床效果,以改善过敏性结膜炎患者预后。方法：选取过敏性结膜炎患者154例158眼,随机分为两组。对照组患者单纯给予氯雷他定片治疗,观察组患者在对照组基础上加用双氯芬酸钠滴眼液进行治疗。对两组患者症状和体征积分进行比较,并对治疗效果进行评价并比较。结果：治疗前,两组患者患眼症状积分和体征积分无统计学差异(P>0.05)。经过治疗,观察组患眼眼痒、流泪、畏光、烧灼感以及异物感积分分别为1.03±0.10、0.83±0.10、0.62±0.06、0.80±0.05和1.10±0.09分,结膜充血水肿、分泌物、睑结膜乳头滤泡、角膜缘改变、角膜上皮改变以及眼睑和球周组织水肿得分分别为0.95±0.08、0.63±0.05、1.32±0.13、0.67±0.06、0.72±0.06和0.55±0.04分,均明显低于对照组,两组比较差异有统计学意义(P<0.05)。对照组患者患眼显效、总有效率分别为30.4％和68.4％;观察组分别为50.6％和86.1％,观察组患者患眼显效率和总有效率均明显高于对照组,两组患眼比较差异有统计学意义(P<0.05)。结论：在全身使用氯雷他定的基础上给予双氯芬酸钠眼液点眼,可以更好地缓解过敏性结膜炎患者的临床症状和体征,提高治疗效果,而且给药方便,是一种有效的治疗方案。     

Comparison of 0.1% Bromfenac Sodium and 0.1% Pemirolast Potassium for the Treatment of Allergic Conjunctivitis

Purpose We compared the efficacy of a new nonsteroidal antiinflammatory drug (NSAID) eye drop, 0.1% bromfenac sodium (Bromfenac), with that of an antiallergic agent, 0.1% pemirolast potassium (Pemirolast), in the treatment of seasonal allergic conjunctivitis in Japanese patients.Methods Twenty-two subjects with seasonal allergic conjunctivitis were enrolled in the study. One eye was treated with Bromfenac eye drops and the contralateral eye was treated with Pemirolast eye drops for 1 week. Subjective ocular symptoms and objective ocular signs evaluated by slit-lamp examination were scored and recorded before and after treatment.Results Both drugs significantly decreased ocular signs after 1 week, but not symptoms. No significant differences in subjective symptoms or objective signs were observed between the two drugs. Ten patients (45.5%) selected Bromfenac as more effective, nine patients (40.9%) selected Pemirolast, and three patients found no difference in efficacy between the two drugs.Conclusion Bromfenac sodium is as safe and effective for the treatment of allergic conjunctivitis as pemirolast potassium. Jpn J Ophthalmol 2004;48:587–590 © Japanese Ophthalmological Society 2004