Phase 3 N=440 Randomized Double-blind Treatment

Efficacy of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery

Pain · Inflammation · Cataract

Bottom Line

View on ClinicalTrials.gov: NCT01367249 ↗

Enrolled (actual)

440

Serious AEs

1.7%

Results posted

May 2014

Primary outcome: Primary: Ocular Inflammation — 108; 53 eyes

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: Jul 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Ocular Inflammation	108; 53	—
SECONDARY Ocular Pain	175; 108	—

Summary

This is an 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 (NCT01367249). 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.