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

Sun Pharma

Status and phase: Completed; Phase 3

Conditions: Ocular Inflammation

Treatments: Drug: ISV-303; Other: DuraSite Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT01808547

C-12-303-004

Details and patient eligibility

About

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

Enrollment: 268 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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268 participants in 2 patient groups, including a placebo group

ISV-303

Experimental group

Treatment:

Drug: ISV-303

Durasite Vehicle

Placebo Comparator group

Treatment:

Other: DuraSite Vehicle