Study to Evaluate ISV-305 Compared to Vehicle for Treatment of Inflammation and Pain Associated With Cataract Surgery

Sun Pharma

Status and phase: Completed; Phase 3

Conditions: Inflammation and Pain Associated With Cataract Surgery

Treatments: Drug: ISV-305; Other: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT03192137

C-13-305-002

Details and patient eligibility

About

The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of ISV-305 (dexamethasone in DuraSite® 2) compared with Vehicle in the treatment of inflammation and pain associated with cataract surgery.

Full description

The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of topical administration of ISV-305 (0.1% dexamethasone in DuraSite® 2) compared with Vehicle when dosed twice daily for 1 day prior to surgery, the day of surgery and 14 days post cataract surgery.

Enrollment: 260 patients

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Are at least 17 years of age
• Are scheduled for uncomplicated unilateral cataract surgery
• Signature of the subject or parent(s) or legally authorized representative on the Informed Consent Form, and when appropriate the minor's assent in accordance with local regulations
• Are willing and able to follow all instructions and attend all study visits
• Are willing to avoid disallowed medication for the duration of the study
• If female is of childbearing potential, agree to and submit a urine sample for pregnancy testing (prior to enrollment and at the end of the study) and use effective contraception for the duration of the study
• Male subjects whose female partners are not post-menopausal must agree to one of the following: 1) completely abstain from sexual intercourse, 2) use a barrier method (condoms) with spermicide during sexual intercourse for the duration of the study, 3) provide documentation for having had a vasectomy (with documented infertility)
• Additional inclusion criteria also apply

Exclusion criteria

• Have known sensitivity or poor tolerance to any component of the study drugs
• Have any sign of iritis or scleritis in the study eye
• Have an acute ocular infection (bacterial, viral or fungal) or active ocular inflammation in the study eye
• Have any active or chronic/recurrent ocular or systemic disease that is uncontrolled and likely to affect wound healing (e.g., diabetes mellitus, systemic connective tissue disease, severe atopic disease)
• Have known blood dyscrasia or bone marrow suppression
• Have any active corneal pathology in the study eye
• Have had radial keratotomy, corneal transplant, or LASIK in the study eye within the last 2 years
• Be currently pregnant, nursing, or planning a pregnancy; or have a positive urine pregnancy test
• Have prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device
• Have 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
• Use of any medication the investigator feels may interfere with the study parameters
• Additional exclusion criteria also apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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260 participants in 2 patient groups, including a placebo group

ISV-305

Experimental group

Description:

0.1% dexamethasone in DuraSite® 2

Treatment:

Drug: ISV-305

Vehicle

Placebo Comparator group

Description:

DuraSite® 2 Vehicle

Treatment:

Other: Vehicle