Efficacy and Safety of Topical Bromfenac Ophthalmic Solution vs. Placebo in Subjects With Allergic Conjunctivitis

March 13, 2013 updated by: Bausch & Lomb Incorporated

Efficacy and Safety of Topical Bromfenac Ophthalmic Solution vs. Placebo in Subjects With a History of Allergic Conjunctivitis

The primary objective of this study is to investigate the efficacy and safety of bromfenac ophthalmic solution for treatment in subjects with a history of allergic conjunctivitis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

90

Phase

  • Phase 3

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

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • History of clinically active allergic conjunctivitis
  • Agree to return for all required visits
  • Agree to avoid disallowed meds

Exclusion Criteria:

  • Known hypersensitivity to bromfenac and salicylates

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bromfenac
Ophthalmic Solution
Drug: Bromfenac
Placebo Comparator: Placebo
Vehicle ophthalmic solution
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Treatment of ocular itching

Secondary Outcome Measures

Outcome Measure
Treatment of chemosis, episcleral and ciliary hyperemia, ocular mucous discharge, eyelid swelling, foreign body sensation, nasal symptoms, and/or tearing

Collaborators and Investigators

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

Sponsor

Bausch & Lomb Incorporated

Investigators

  • Study Director: Jon Williams, PhD, ISTA Pharmaceuticals, Inc.

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

November 1, 2006

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

January 15, 2007

First Submitted That Met QC Criteria

January 15, 2007

First Posted (Estimate)

January 17, 2007

Study Record Updates

Last Update Posted (Estimate)

March 14, 2013

Last Update Submitted That Met QC Criteria

March 13, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISTA-BR-CS03

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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