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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00423007
Recruitment Status : Completed
First Posted : January 17, 2007
Last Update Posted : March 14, 2013
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Allergic Conjunctivitis Drug: Bromfenac Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Topical Bromfenac Ophthalmic Solution vs. Placebo in Subjects With a History of Allergic Conjunctivitis
Study Start Date : November 2006
Primary Completion Date : August 2007
Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Pinkeye
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Bromfenac
Ophthalmic Solution
Drug: Bromfenac
Placebo Comparator: Placebo
Vehicle ophthalmic solution
Drug: Placebo

Primary Outcome Measures :
  1. Treatment of ocular itching

Secondary Outcome Measures :
  1. Treatment of chemosis, episcleral and ciliary hyperemia, ocular mucous discharge, eyelid swelling, foreign body sensation, nasal symptoms, and/or tearing

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00423007

United States, California
ISTA Pharmaceuticals, Inc.
Irvine, California, United States, 92618
Sponsors and Collaborators
Bausch & Lomb Incorporated
Study Director: Jon Williams, PhD ISTA Pharmaceuticals, Inc.

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00423007     History of Changes
Other Study ID Numbers: ISTA-BR-CS03
First Posted: January 17, 2007    Key Record Dates
Last Update Posted: March 14, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Immune System Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents