Study to Compare Differing Dosing Regimens of ISV-303 (Bromfenac in DuraSite) to Xibrom and Vehicle in Post Cataract Surgery Volunteers

Sun Pharma

Status and phase: Completed; Phase 2; Phase 1

Conditions: Ocular Inflammation

Treatments: Drug: Xibrom™; Drug: ISV-303; Drug: DuraSite Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT01190878

C-10-303-001

Details and patient eligibility

About

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.

Enrollment: 169 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation on the day prior to study enrollment
• Meet the best corrected visual acuity score requirement
• Meet the IOP requirement
• Additional inclusion criteria also apply

Exclusion criteria

• Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the study medications or any of the procedural medications
• Use of any ocular topical, or systemic medication that could interfere with normal lacrimation, wound healing, the test agent, or the interpretation of study results, within 1 week prior to Day of Surgery
• Additional exclusion criteria also apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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169 participants in 4 patient groups, including a placebo group

ISV-303 BID

Experimental group

Treatment:

Drug: ISV-303

Drug: ISV-303

ISV-303 QD

Experimental group

Treatment:

Drug: ISV-303

Drug: ISV-303

Xibrom BID

Active Comparator group

Treatment:

Drug: Xibrom™

DuraSite Vehicle BID

Placebo Comparator group

Treatment:

Drug: DuraSite Vehicle