Phase 3 N=126 Randomized Double-blind Treatment

Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

Cataract

Bottom Line

View on ClinicalTrials.gov: NCT00703781 ↗

Enrolled (actual)

126

Serious AEs

1.6%

Results posted

Dec 2011

Primary outcome: Primary: Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero — 28; 20 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: bromfenac ophthalmic solution (Drug); placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bausch & Lomb Incorporated
Primary completion: Nov 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero	28; 20	—
SECONDARY Number of Participants That Are Pain Free	51; 46	—

Summary

Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

Eligibility Criteria

Inclusion Criteria

Scheduled for cataract surgery

Exclusion Criteria

Known hypersensitivity to bromfenac and salicylates

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00703781). 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.