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NCT00423007 Clinical Trial

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

Allergic Conjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00423007
Other study ID # ISTA-BR-CS03
Secondary ID
Status Completed
Phase Phase 3
First received January 15, 2007
Last updated March 13, 2013
Start date November 2006
Est. completion date August 2007

Study information
Verified date March 2013
Source Bausch & Lomb Incorporated
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date August 2007
Est. primary completion date August 2007
Accepts healthy volunteers No
Gender Both
Age group 10 Years and older
Eligibility 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 Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Bromfenac

• Placebo

Locations
Country Name City State
United States ISTA Pharmaceuticals, Inc. Irvine California

Sponsors (1)
Lead Sponsor Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Treatment of ocular itching No
Secondary Treatment of chemosis, episcleral and ciliary hyperemia, ocular mucous discharge, eyelid swelling, foreign body sensation, nasal symptoms, and/or tearing No
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