Comparison Study of ISV-303 to Durasite Vehicle in Cataract Surgery Subjects

Phase 3

Completed

• Conditions: Ocular Inflammation
• Interventions: Drug: ISV-303; Other: DuraSite Vehicle

• Registration Number: NCT01808547
• Lead Sponsor: Sun Pharmaceutical Industries Limited

Brief Summary

The purpose of this study is to evaluate the ocular safety, tolerability and efficacy of topical administration of ISV-303 compared with Durasite Vehicle.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-07
• Study First Submitted QC: 2013-03-07
• Study First Posted: 2013-03-11
• Study Start: 2013-05
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Disposition First Submitted: 2015-03-30
• Disposition First Submitted QC: 2015-03-30
• Disposition First Posted: 2015-04-17
• Results First Submitted: 2016-04-26
• Results First Submitted QC: 2016-06-02
• Results First Posted: 2016-07-13
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-18
• Last Update Posted: 2021-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 268

Inclusion Criteria

• Male or female subjects age 18 or older scheduled for unilateral cataract surgery with posterior chamber intraocular lens implantation
• If a female is of childbearing potential, the subject must agree to and submit a negative pregnancy test before any protocol-specific procedures are conducted. The subject must use effective contraception for the duration of the study. Post menopausal is defined as having no menses for at least 12 consecutive months
• Signature of the subject on the Informed Consent Form
• Willing to avoid disallowed medications for the duration of the study
• Willing and able to follow all instructions and attend all study visits
• Able to self-administer the IMP (or have a caregiver available to instill all doses of study drugs )
• Additional inclusion criteria also apply

Exclusion Criteria

• Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the IMP or any of the procedural medications
• Currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive pregnancy test
• Currently suffer from alcohol and/or drug abuse
• Prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device
• A condition or a situation, which in the investigator's opinion may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation
• Additional inclusion criteria also apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ISV-303	ISV-303	-
Durasite Vehicle	DuraSite Vehicle	-

Primary Outcome Measures

Name	Time	Method
Ocular Inflammation	15 days	Anterior chamber cell grade 0 at Day 15 measured on a 0 to 4 scale where "0" is 0 cells; "1" is 1-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is \> 50 cells, and no rescue medications.