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NCT01277341 Clinical Trial

Safety and Efficacy of Bepotastine Besilate Nasal Spray in the Treatment of Seasonal Allergic Rhinitis

Seasonal Allergic Rhinitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01277341
Other study ID # S00082
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date December 2010
Est. completion date May 2011

Study information
Verified date October 2020
Source Bausch & Lomb Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is an efficacy study of bepotastine besilate nasal spray in seasonal allergic rhinitis.

Recruitment information / eligibility
Status Completed
Enrollment 601
Est. completion date May 2011
Est. primary completion date February 2011
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Bepotastine Besilate Nasal Spray 2% Twice a day
nasal spray
• Bepotastine Besilate Nasal Spray 3% Twice a day
nasal spray
• Bepotastine Besilate Nasal Spray 4% Twice a day
nasal spray
• Placebo Nasal Spray
nasal spray

Locations
Country Name City State
United States ISTA Pharmaceuticals, Inc. Irvine California

Sponsors (1)
Lead Sponsor Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean Change From Baseline (Pre-Dose) in Subject-rated Reflective TNSS 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. Baseline, 14 days
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