Phase 3 N=299 Randomized Double-blind Treatment

Efficacy Study of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery

Pain · Inflammation

Bottom Line

View on ClinicalTrials.gov: NCT00853970 ↗

Enrolled (actual)

299

Serious AEs

1.0%

Results posted

Jan 2011

Primary outcome: Primary: Summed Ocular Inflammation Score (SOIS) of Zero — 70; 36 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Bromfenac Ophthalmic Solution (Drug); Placebo Comparator (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bausch & Lomb Incorporated
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Summed Ocular Inflammation Score (SOIS) of Zero	70; 36	—
SECONDARY Pain Free	135; 105	—

Summary

Efficacy study of Bromfenac Ophthalmic Solution in cataract surgery

Eligibility Criteria

Inclusion Criteria

Male or female at least 18 years of age who are scheduled for unilateral cataract surgery

Exclusion Criteria

Have known hypersensitivity to bromfenac or to any component of the investigational product

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00853970). 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.