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

Ocular Inflammation Clinical Trial

Official title:

A Randomized Double-Masked Study to Compare the Ocular Safety,Tolerability,and Efficacy of ISV-303 to Durasite Vehicle in Cataract Surgery Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01808547
• Other study ID #: C-12-303-004
• Status: Completed
• Phase: Phase 3
• Start date: May 2013
• Est. completion date: November 2013

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 of topical administration of ISV-303 compared with Durasite Vehicle.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Inflammation
• Ocular Inflammation

Intervention

Drug:
• ISV-303
0.075% bromfenac in DuraSite dosed BID

Other:
• DuraSite Vehicle
DuraSite vehicle 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 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