A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease

Bausch + Lomb

Status and phase: Completed; Phase 3

Conditions: Dry Eye Syndrome

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01212471

S00007

Details and patient eligibility

About

A dose ranging study to evaluate safety and efficacy of bromfenac ophthalmic solution in dry eye disease.

Enrollment: 840 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be of either gender and any race 18 years or older

Exclusion criteria

• Have a local or systemic disease that could interfere with the assessment of safety or efficacy or that is likely to result in early discontinuation from the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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840 participants in 3 patient groups, including a placebo group

Bromfenac Ophthalmic Solution A

Experimental group

Description:

Bromfenac ophthalmic solution A

Treatment:

Drug: Bromfenac Ophthalmic Solution A

Bromfenac Ophthalmic Solution B

Experimental group

Description:

Bromfenac ophthalmic solution B

Treatment:

Drug: Bromfenac Ophthalmic Solution B

Placebo Comparator

Placebo Comparator group

Description:

Placebo Comparator

Treatment:

Drug: Placebo Comparator