Alcaftadine 0.25% versus Olopatadine 0.1% in Preventing Cedar Pollen Allergic Conjunctivitis in Japan: A Randomized Study.

Purpose: To compare alcaftadine and olopatadine ophthalmic solutions, and vehicle for preventing allergen-mediated conjunctivitis in Japanese subjects. Methods: Japanese cedar pollen-sensitive subjects were randomized to alcaftadine 0.25%, olopatadine 0.1%, or vehicle. Ocular itching was assessed at 3, 5 (primary outcome), 7, and 15 min post-conjunctival allergen challenge (CAC) and conjunctival hyperemia assessed at 7, 15 (secondary outcome), and 20 min post-CAC. Adverse events were monitored. Results: Overall, 240 subjects were randomized. Alcaftadine 0.25% (challenged 8 h post-dose) was significantly more effective than vehicle for prevention of itching and conjunctival hyperemia (p < 0.001) and noninferior to olopatadine 0.1% (challenged 4 h post-dose). Significantly lower hyperemia scores were observed in alcaftadine-treated than olopatadine-treated eyes at 7 and 15 min post-CAC (p ≤ 0.027). Alcaftadine and olopatadine were well tolerated; no serious adverse events were reported. Conclusion: Alcaftadine 0.25% is effective in preventing signs and symptoms of Japanese cedar pollen-induced allergic conjunctivitis.

Efficacy and tolerability of ophthalmic epinastine: a randomized, double-masked, parallel-group, active- and vehicle-controlled environmental trial in patients with seasonal allergic conjunctivitis.

BACKGROUND: Epinastine hydrochloride is an antihistamine with mast cell-stabilizing and anti-inflammatory activity. OBJECTIVE: The aim of this study was to assess the efficacy and tolerability of ophthalmic epinastine in patients with seasonal allergic conjunctivitis (SAC) exposed to environmental allergens. METHODS: This randomized (age-stratified), double-masked, parallel-group, active- and vehicle-controlled, environmental, Phase III clinical trial was conducted at 6 ophthalmology clinics in the United States. Patients aged >or=9 years diagnosed with SAC and who had a positive reaction in a conjunctival allergen challenge were enrolled. Patients were randomly assigned in a 2:2:1 ratio to receive 1 drop/eye BID of epinastine hydrochloride 0.05% ophthalmic solution, levocabastine hydrochloride 0.05% ophthalmic suspension, or vehicle of epinastine, respectively, for 8 weeks. The primary end point was ocular itching, and secondary end points included ocular hyperemia, chemosis, ocular mucous discharge (all assessed on a 5-point scale), eyelid swelling (assessed on a 4-point scale), and tearing (present or absent). Efficacy analyses used assessments from the two 1-week periods with the highest pollen counts. For tolerability assessment slit-lamp biomicroscopy and visual acuity examinations were conducted at each study visit (weeks 0, 2, 4, 6, and 8). RESULTS: Two-hundred ninety-eight patients (159 females, 139 males; mean [SD] age, 32.7 [14.6] years [range, 9-71 years]) entered the study; 118 received epinastine, 118 received levocabastine, and 62 received vehicle. Epinastine-treated patients reported significantly less ocular itching than those receiving vehicle (P=0.045); scores for hyperemia were similar between these 2 groups. Ocular itching and hyperemia scores were similar between the epinastine and levocabastine groups. No clinically or statistically significant between-group differences were seen in slit-lamp biomicroscopy findings, changes in visual acuity from baseline, or the incidence of treatment-related adverse effects. CONCLUSIONS: In this study of patients with SAC, ophthalmic epinastine instilled twice daily was more effective than vehicle for the control of ocular itching and was similar in efficacy to levocabastine for control of ocular itching and hyperemia. Epinastine was well tolerated.

Efficacy and tolerability of ophthalmic epinastine assessed using the conjunctival antigen challenge model in patients with a history of allergic conjunctivitis.

BACKGROUND: Epinastine hydrochloride is a nonsedating antihistamine with a high affinity for histamine H(1) receptors, together with mast cell-stabilizing and anti-inflammatory activities. OBJECTIVE: The aim of this study was to assess the efficacy and tolerability of topically administered ophthalmic epinastine using the conjunctival antigen challenge (CAC) model in patients with a history of allergic conjunctivitis. METHODS: This prospective, single-center, randomized, double-masked, vehicle-controlled, Phase III clinical trial was conducted at the Ophthalmic Research Associates study center (North Andover, Massachusetts) from November 2000 to January 2001. Eligible participants were asymptomatic but had a history of allergic conjunctivitis and had positive CAC reactions at the initial screening (week 0) and at a confirmation visit (week 1). Patients were randomly assigned by eye to receive epinastine hydrochloride 0.05% ophthalmic solution in 1 eye and vehicle in the contralateral eye. Each eye received 1 drop of study medication 15 minutes before antigen application (onset challenge; week 3) or 8 hours before antigen application (duration challenge; week 5). Primary end points were ocular itching and conjunctival hyperemia. Itching was recorded 3, 5, and 10 minutes after antigen challenge. Hyperemia was recorded 5, 10, and 20 minutes after antigen challenge, as were secondary end points, which included eyelid swelling, episcleral and ciliary hyperemia, chemosis, tearing, and ocular mucous discharge. Tolerability was assessed by patient interview and slit-lamp biomicroscopy. RESULTS: Sixty-seven patients (37 females, 30 males; mean [SD] age, 38.4 [14.2] years [range, 12-67 years]) were included in the study. Mean severity scores for the following signs and symptoms were significantly lower with epinastine compared with vehicle at all time points after onset and duration challenges: ocular itching (P<0.001); eyelid swelling (P<0.001); conjunctival ( P<0.001), episcleral ( P<0.001), and ciliary hyperemia (P<0.001); and chemosis (Por=8 hours). The tolerability of epinastine was similar to that of vehicle.