ABSTRACT
Purpose: This study evaluated the efficacy and safety of once-daily Alcaftadine 0.25% (AGN-229666) for prevention of signs and symptoms of Japanese cedar-pollen allergic conjunctivitis.Methods: This was a single-center, placebo-, and comparator-controlled study using the Ora-CAC® model of allergic conjunctivitis. The primary endpoint was ocular itching 16 hours after Alcaftadine 0.25% instillation; efficacy at 16 hours was compared with 0.1% Olopatadine, 4 hours after instillation. Secondary endpoints included conjunctival hyperemia.Results: 263 Japanese subjects were enrolled; 224 completed the trial. Alcaftadine 0.25% was statistically superior to vehicle for relief of ocular itching at 16 hours (p < .0001). Alcaftadine 0.25% at 16 hours was non-inferior to Olopatadine at 4 hours. Alcaftadine 0.25% was significantly better than vehicle for relief of conjunctival hyperemia. All treatments showed a low frequency of ocular adverse events.Conclusion: Once-daily Alcaftadine 0.25% is safe and effective in preventing signs and symptoms of Japanese cedar-pollen allergic conjunctivitis.
Subject(s)
Benzazepines/administration & dosage , Conjunctivitis, Allergic/prevention & control , Cryptomeria/chemistry , Histamine H1 Antagonists/administration & dosage , Imidazoles/administration & dosage , Pollen/adverse effects , Administration, Ophthalmic , Adult , Allergens/adverse effects , Conjunctivitis, Allergic/chemically induced , Conjunctivitis, Allergic/diagnosis , Double-Blind Method , Female , Histamine H1 Antagonists, Non-Sedating/administration & dosage , Humans , Male , Middle Aged , Olopatadine Hydrochloride/administration & dosage , Ophthalmic Solutions , Prospective Studies , Treatment OutcomeABSTRACT
PURPOSE: The purpose of this study was to estimate the optimal size of visual field test for detecting longitudinal changes in retinitis pigmentosa (RP) by dividing the visual field. METHODS: We reviewed the results of 10° static visual field tests in 19 eyes of 19 RP patients. Sixty-eight numeric value points were divided into two area types: concentric areas (A1, A1-2, A1-3, A1-4, A1-5, A1-6) and circular areas (A1, A2, A3, A4, A5, A6). Serial values of mean sensitivity in each area of each patient were analyzed by linear regression. RESULTS: Analysis of the concentric areas showed that 10 of 19 eyes had the best R (2) value in the most central area, A1. Analysis of circular areas showed that 7 of 19 eyes had the steepest slope of decline in A1. The inner-segment/outer-segment (IS/OS) line was significantly shorter in eyes with low variability and evident disease progression in the inner areas than the ones in the outer areas. CONCLUSIONS: The optimal size of monitoring RP progression was different in each case and may depend on the remaining morphology of the outer retina.
