Back to results

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

Primary Purpose

Ocular Inflammation

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

ISV-303

DuraSite Vehicle

Xibrom™

About this trial

This is an interventional treatment trial for Ocular Inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

ISV-303 BID

ISV-303 QD

Xibrom BID

DuraSite Vehicle BID

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01190878

First Posted

August 26, 2010

Last Updated

November 18, 2021

Sponsor

Sun Pharmaceutical Industries Limited

1. Study Identification

Unique Protocol Identification Number

NCT01190878

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

August 2010 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sun Pharmaceutical Industries Limited

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ocular Inflammation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

169 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ISV-303 BID

Arm Type

Experimental

Arm Title

ISV-303 QD

Arm Type

Experimental

Arm Title

Xibrom BID

Arm Type

Active Comparator

Arm Title

DuraSite Vehicle BID

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

ISV-303

Intervention Description

0.075% of bromfenac in DuraSite dosed QD

Intervention Type

Drug

Intervention Name(s)

ISV-303

Intervention Description

0.075% of bromfenac in DuraSite dosed BID

Intervention Type

Drug

Intervention Name(s)

DuraSite Vehicle

Intervention Description

Vehicle dosed BID

Intervention Type

Drug

Intervention Name(s)

Xibrom™

Intervention Description

0.09% bromfenac dosed BID

Primary Outcome Measure Information:

Title

Ocular Inflammation

Description

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.

Time Frame

15 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Citations:

PubMed Identifier

28819932

Citation

Trattler W, Hosseini K. Twice-Daily vs. Once-Daily Dosing with 0.075% Bromfenac in DuraSite: Outcomes from a 14-Day Phase 2 Study. Ophthalmol Ther. 2017 Dec;6(2):277-284. doi: 10.1007/s40123-017-0102-x. Epub 2017 Aug 17.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs