Safety, Pharmacokinetics, and Efficacy of Bepotastine Besilate Nasal Product After Ragweed Pollen Exposure in an Environmental Chamber

October 1, 2020 updated by: Bausch & Lomb Incorporated
The purpose of this study is to examine the safety and efficacy of bepotastine besilate nasal product in seasonal allergic rhinitis patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92618
        • ISTA Pharmaceuticals, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects 18 to 65 years of age with a positive skin prick test with ragweed allergen

Exclusion Criteria:

  • No active respiratory tract infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm 1 - Low Dose
bepotastine besilate nasal product - low dose
Drug: bepotastine besilate nasal product - low dose
sterile nasal product
EXPERIMENTAL: Arm 2 - Medium Dose
bepotastine besilate nasal product - medium dose
Drug: bepotastine besilate nasal product - medium dose
sterile nasal product
EXPERIMENTAL: Arm 3 - High Dose
bepotastine besilate nasal product - high dose
Drug: bepotastine besilate nasal product - high dose
sterile nasal product
PLACEBO_COMPARATOR: Arm 4 - Placebo
placebo comparator nasal product
Drug: placebo comparator nasal product
sterile nasal product

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline (Pre-Dose) in Subject-rated Instantaneous TNSS
Time Frame: Baseline, 20 days
Total nasal symptom scores (TNSS) was the summed scores for nasal pruritus [itching], rhinorrhea [runny nose], nasal congestion, and sneezing. Individual nasal symptoms were 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 maximum score for increased allergic response of 12 units. The minimum possible total score was 0.
Baseline, 20 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch & Lomb Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ACTUAL)

August 1, 2010

Study Completion (ACTUAL)

August 1, 2010

Study Registration Dates

First Submitted

October 14, 2010

First Submitted That Met QC Criteria

October 15, 2010

First Posted (ESTIMATE)

October 18, 2010

Study Record Updates

Last Update Posted (ACTUAL)

October 5, 2020

Last Update Submitted That Met QC Criteria

October 1, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S00032

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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