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Safety and Efficacy of Bepotastine Besilate Ophthalmic Solution in Seasonal Allergic Conjunctivitis Patients
The purpose of this study is to study the safety and efficacy of bepotastine besilate ophthalmic solution in allergic conjunctivitis patients.
Details
| Lead sponsor | Bausch & Lomb Incorporated |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 245 |
| Start date | 2010-06 |
| Completion | 2010-12 |
Conditions
- Allergic Conjunctivitis
Interventions
- bepotastine besilate ophthalmic solution
- placebo comparator ophthalmic solution
Primary outcomes
- Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Mean Change in Total Score — Baseline, 14 days
Responses to questions relating to symptoms and daily activities in the RQLQ were provided for 28 questions encompassing the 7 major domains of activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional state. Each response to an RQLQ question was provided on a scale of 0-6 units, where 0 = not troubled/none of the time and 6 = extremely troubled/all of the time. The minimum total score was 0 units and the maximum total score was 42 units, with higher score indicating decreased quality of life due to rhinoconjunctivitis.
Countries
United States