NCT00423007CompletedPhase 3
Efficacy and Safety of Topical Bromfenac Ophthalmic Solution vs. Placebo in Subjects With a History of Allergic Conjunctivitis
Bausch & Lomb Incorporated1 site in 1 country90 target enrollmentStarted: November 2006Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Bausch & Lomb Incorporated
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Treatment of ocular itching
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 10 Years to — (Child, Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Bromfenac
Experimental
Ophthalmic Solution
Intervention: Bromfenac (Drug)
Placebo
Placebo Comparator
Vehicle ophthalmic solution
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Treatment of ocular itching
Secondary Outcomes
- Treatment of chemosis, episcleral and ciliary hyperemia, ocular mucous discharge, eyelid swelling, foreign body sensation, nasal symptoms, and/or tearing
Investigators
Study Sites (1)
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