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

Completed · Phase 3

Conditions studied: Inflammation and Pain Associated With Cataract Surgery

In brief

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.

Key facts

Study ID

NCT03192137

Run by

Sun Pharmaceutical Industries Limited

People needed

260

Starts

2018-01-30

Expected to finish

2019-04-17

Last updated by the study team

2021-11-19

Who can join

Age: 17 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinical Research Center — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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