search
Back to results

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

Primary Purpose

Seasonal Allergic Rhinitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bepotastine Besilate Nasal Spray 2% Twice a day
Bepotastine Besilate Nasal Spray 3% Twice a day
Bepotastine Besilate Nasal Spray 4% Twice a day
Placebo Nasal Spray
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ISTA Pharmaceuticals, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

2% Twice a day

3% Twice a day

4% Twice a day

Placebo

Arm Description

Bepotastine Besilate Nasal Spray 2% Twice a day

Bepotastine Besilate Nasal Spray 3% Twice a day

Bepotastine Besilate Nasal Spray 4% Twice a day

Placebo nasal spray

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 7, 2011
Last Updated
October 1, 2020
Sponsor
Bausch & Lomb Incorporated
search

1. Study Identification

Unique Protocol Identification Number
NCT01277341
Brief Title
Safety and Efficacy of Bepotastine Besilate Nasal Spray in the Treatment of Seasonal Allergic Rhinitis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
601 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2% Twice a day
Arm Type
Experimental
Arm Description
Bepotastine Besilate Nasal Spray 2% Twice a day
Arm Title
3% Twice a day
Arm Type
Experimental
Arm Description
Bepotastine Besilate Nasal Spray 3% Twice a day
Arm Title
4% Twice a day
Arm Type
Experimental
Arm Description
Bepotastine Besilate Nasal Spray 4% Twice a day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo nasal spray
Intervention Type
Drug
Intervention Name(s)
Bepotastine Besilate Nasal Spray 2% Twice a day
Intervention Description
nasal spray
Intervention Type
Drug
Intervention Name(s)
Bepotastine Besilate Nasal Spray 3% Twice a day
Intervention Description
nasal spray
Intervention Type
Drug
Intervention Name(s)
Bepotastine Besilate Nasal Spray 4% Twice a day
Intervention Description
nasal spray
Intervention Type
Drug
Intervention Name(s)
Placebo Nasal Spray
Intervention Description
nasal spray
Primary Outcome Measure Information:
Title
Mean Change From Baseline (Pre-Dose) in Subject-rated Reflective TNSS
Description
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.
Time Frame
Baseline, 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim McNamara, PharmD
Organizational Affiliation
ISTA Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
ISTA Pharmaceuticals, Inc.
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs