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

NCT01808547 | Completed Phase 3 Results

• 1 other identifier: C-12-303-004
• Study Type: interventional
• Target: 268
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ocular Inflammation

Outcome Measures

Primary Outcomes (1)

• Ocular Inflammation

  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.

  15 days

Study Arms (2)

ISV-303

EXPERIMENTAL

Drug: ISV-303

Durasite Vehicle

PLACEBO COMPARATOR

Other: DuraSite Vehicle

Interventions

ISV-303 DRUG

0.075% bromfenac in DuraSite dosed BID

ISV-303

DuraSite Vehicle OTHER

DuraSite vehicle dosed BID

Durasite Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 )

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Pharmaceutical Industries Limited: lead

MeSH Terms

Interventions

bromfenac

Results Point of Contact

• Title: Senior Manager, Clinical Sciences
• Organization: InSite Vision

manjiri.desai@sparcmail.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2013
• First Posted: March 11, 2013
• Study Start: May 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 19, 2021
• Results First Posted: July 13, 2016

Record last verified: 2021-11