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

Ocular Inflammation Clinical Trial

Official title:

A Randomized Double-masked 14-day Study to Compare the Ocular Safety, Tolerability, and Efficacy of Differing Dosing Regimens of ISV-303 to Vehicle and Xibrom™ in Post Cataract Surgery Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01190878
• Other study ID #: C-10-303-001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 2010
• Est. completion date: January 2011

Study information

• Verified date: November 2021
• Source: Sun Pharmaceutical Industries Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Inflammation
• Ocular Inflammation

Intervention

Drug:
• ISV-303
0.075% of bromfenac in DuraSite dosed QD
• ISV-303
0.075% of bromfenac in DuraSite dosed BID
• DuraSite Vehicle
Vehicle dosed BID
• Xibrom™
0.09% bromfenac dosed BID

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Pharmaceutical Industries Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular Inflammation	Anterior Chamber Cell Grade 0 at Day 15 measured on a 0 to 4 scale: "0" is 0 cells; "1" is 1-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is > 50 cells.	15 days