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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Bausch & Lomb Incorporated

ClinicalTrials.gov Identifier:

NCT00423007

First received: January 15, 2007

Last updated: March 13, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 15, 2007

Last Updated Date

March 13, 2013

Start Date ^ICMJE

November 2006

Primary Completion Date

August 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Treatment of ocular itching [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Treatment of ocular itching

Change History

Complete list of historical versions of study NCT00423007 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Treatment of chemosis, episcleral and ciliary hyperemia, ocular mucous discharge, eyelid swelling, foreign body sensation, nasal symptoms, and/or tearing [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Allergic Conjunctivitis

Intervention ^ICMJE

Drug: Bromfenac
Drug: Placebo

Study Arm (s)

Experimental: Bromfenac
Ophthalmic Solution

Intervention: Drug: Bromfenac
Placebo Comparator: Placebo
Vehicle ophthalmic solution

Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2007

Primary Completion Date

August 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

10 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00423007

Other Study ID Numbers ^ICMJE

ISTA-BR-CS03

Has Data Monitoring Committee

Responsible Party

Bausch & Lomb Incorporated

Study Sponsor ^ICMJE

Bausch & Lomb Incorporated

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Jon Williams, PhD

ISTA Pharmaceuticals, Inc.

Information Provided By

Bausch & Lomb Incorporated

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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