Safety Study for Bepotastine Besilate Ophthalmic Solution in Normal Volunteers
- Registration Number
- NCT00586625
- Lead Sponsor
- Bausch & Lomb Incorporated
- Brief Summary
Safety study for bepotastine besilate ophthalmic solution in normal volunteers
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 861
Inclusion Criteria
- Subjects must be at least 3 years of age, and have ocular health within normal limits
Exclusion Criteria
- No active ocular disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bepreve Bepreve bepotastine besilate ophthalmic solution 1.5% Placebo Placebo vehicle
- Primary Outcome Measures
Name Time Method Ocular Comfort Day 8 & Day 22 A 4-step grading scale with half unit (1-step) increments allowed:
0=Comfortable;discomfort absent; 1.0=Generally comfortable; mild discomfort; 2.0=Some discomfort but tolerable; moderate comfort; 3.0=Severely uncomfortable or intolerable
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of bepotastine besilate in allergic conjunctivitis treatment?
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Are there specific biomarkers that correlate with improved safety outcomes in bepotastine besilate trials?
What are the most common adverse events reported in phase 3 trials of Bepreve for allergic conjunctivitis?
What are the current combination therapies involving antihistamines like Bepreve for allergic conjunctivitis?