Safety and Efficacy of Bepotastine Besilate Nasal Spray in the Treatment of Seasonal Allergic Rhinitis
Phase 2
Completed
- Conditions
- Seasonal Allergic Rhinitis
- Interventions
- Registration Number
- NCT01277341
- Lead Sponsor
- Bausch & Lomb Incorporated
- Brief Summary
This is an efficacy study of bepotastine besilate nasal spray in seasonal allergic rhinitis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 601
Inclusion Criteria
- Male or female at least 12 years of age with a history of mountain cedar allergy
Exclusion Criteria
- No active nasal infection or nasal abnormality that would affect subject safety or symptom assessments
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 4% Twice a day Bepotastine Besilate Nasal Spray 4% Twice a day Bepotastine Besilate Nasal Spray 4% Twice a day 2% Twice a day Bepotastine Besilate Nasal Spray 2% Twice a day Bepotastine Besilate Nasal Spray 2% Twice a day 3% Twice a day Bepotastine Besilate Nasal Spray 3% Twice a day Bepotastine Besilate Nasal Spray 3% Twice a day Placebo Placebo Nasal Spray Placebo nasal spray
- Primary Outcome Measures
Name Time Method Mean Change From Baseline (Pre-Dose) in Subject-rated Reflective TNSS Baseline, 14 days Total nasal symptom score (TNSS) was the summed scores for nasal pruritus \[itching\], rhinorrhea \[runny nose\], nasal congestion, and sneezing. Individual nasal symptoms were each rated on a 4-point scale from 0-3 (0=Absent, 1=Mild, 2=Moderate, 3=Severe), with no half-unit assessments. TNSS was the sum score of 4 nasal symptoms with a minimum score of 0 units and a maximum score of 12 units, with higher score corresponding to increased nasal allergy symptoms. Morning and evening scores were averaged.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
ISTA Pharmaceuticals, Inc.
🇺🇸Irvine, California, United States