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

• Status: Completed
• Trial end date: 2019-04-17
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: InSite Vision; Sun Pharma Global FZE
• Treatments: Dexamethasone

Criteria

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