Purpose: To study the tolerability and efficacy of two formulations of topical ketotifen ophthalmic solutions for the treatment of seasonal allergic conjunctivitis (SAC). Methods:81 active SAC patients were treated with either ketotifen 0.025% or 0.05% eye drops for 3 weeks. Allergic signs and symptoms were evaluated at baseline (V0), after 7 (V1) and 21 days (V2). Drugs tolerability and ratings of global efficacy were recorded. Results: Both concentrations of ketotifen were highly effective. The total signs and symptoms scores (TSSS) were significantly better reduced by ketotifen 0.025% compared to 0.05% at both V1 and V2 (p < 0.001). Ketotifen 0.025% was better tolerated than 0.05% at the first instillation and at days 2, 4, and 6 (p < 0.0001), and had a better responder rate (p < 0.001) according to the patient's and investigator's assessments.Conclusions: Ketotifen 0.025% was more effective and better tolerated than 0.05% in SAC.
RCT Entities:
Purpose: To study the tolerability and efficacy of two formulations of topical ketotifen ophthalmic solutions for the treatment of seasonal allergic conjunctivitis (SAC). Methods: 81 active SAC patients were treated with either ketotifen 0.025% or 0.05% eye drops for 3 weeks. Allergic signs and symptoms were evaluated at baseline (V0), after 7 (V1) and 21 days (V2). Drugs tolerability and ratings of global efficacy were recorded. Results: Both concentrations of ketotifen were highly effective. The total signs and symptoms scores (TSSS) were significantly better reduced by ketotifen 0.025% compared to 0.05% at both V1 and V2 (p < 0.001). Ketotifen 0.025% was better tolerated than 0.05% at the first instillation and at days 2, 4, and 6 (p < 0.0001), and had a better responder rate (p < 0.001) according to the patient's and investigator's assessments.Conclusions: Ketotifen 0.025% was more effective and better tolerated than 0.05% in SAC.