Efficacy Study of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery

Bausch + Lomb

Status and phase: Completed; Phase 3

Conditions: Inflammation; Pain

Treatments: Drug: Placebo Comparator; Drug: Bromfenac Ophthalmic Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00853970

CL-S&E-1205081-P

Details and patient eligibility

About

Efficacy study of Bromfenac Ophthalmic Solution in cataract surgery

Enrollment: 299 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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299 participants in 2 patient groups, including a placebo group

Bromfenac ophthalmic solution 0.09%

Experimental group

Description:

dosed 1 drop daily in study eye for 2 weeks

Treatment:

Drug: Bromfenac Ophthalmic Solution

Placebo

Placebo Comparator group

Description:

dosed 1 drop daily in study eye for 2 weeks

Treatment:

Drug: Placebo Comparator