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

Bausch + Lomb

Status and phase: Completed; Phase 3

Conditions: Allergic Conjunctivitis

Treatments: Drug: Bromfenac; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00423007

ISTA-BR-CS03

Details and patient eligibility

About

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

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups, including a placebo group

Bromfenac

Experimental group

Description:

Ophthalmic Solution

Treatment:

Drug: Bromfenac

Placebo

Placebo Comparator group

Description:

Vehicle ophthalmic solution

Treatment:

Drug: Placebo