Conditions: Ocular Inflammation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 169
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy in topical administration of differing dosing regimens of ISV-303 compared to vehicle and Xibrom™ when dosed for 2 weeks in post-cataract-surgery volunteers.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: ISV-303 intervention 2: ISV-303 intervention 3: DuraSite Vehicle intervention 4: Xibrom™
Intervention descriptions: intervention 1: 0.075% of bromfenac in DuraSite dosed QD intervention 2: 0.075% of bromfenac in DuraSite dosed BID intervention 3: Vehicle dosed BID intervention 4: 0.09% bromfenac dosed BID

Protocol document: