Phase 2 N=568 Randomized Triple-blind Treatment

Efficacy and Safety of Bromfenac Ophthalmic Solution

Cataract Surgery

Bottom Line

View on ClinicalTrials.gov: NCT00585975 ↗

Enrolled (actual)

568

Serious AEs

0.9%

Results posted

Dec 2011

Primary outcome: Primary: Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero — 157; 164 Participant

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: bromfenac ophthalmic solution (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bausch & Lomb Incorporated
Primary completion: Jul 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero	157; 164	—
SECONDARY Number of Participants That Are Pain Free	221; 235	—

Summary

This is a safety and efficacy study of bromfenac ophthalmic solution

Eligibility Criteria

Inclusion Criteria

Male or female greater than or equal to 18 years of age, and scheduled for cataract surgery

Exclusion Criteria

Active corneal pathology in either eye

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00585975). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.