Study to Evaluate ISV-305 Compared to Vehicle for Treatment of Inflammation and Pain Associated With Cataract Surgery
NCT ID: NCT03192137
Last Updated: 2021-11-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
260 participants
INTERVENTIONAL
2018-01-30
2019-04-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ISV-305
0.1% dexamethasone in DuraSite® 2
ISV-305
Dexamethasone in DuraSite® 2 twice daily for 16 days
Vehicle
DuraSite® 2 Vehicle
Vehicle
Vehicle twice daily for 16 days
Interventions
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ISV-305
Dexamethasone in DuraSite® 2 twice daily for 16 days
Vehicle
Vehicle twice daily for 16 days
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
17 Years
ALL
No
Sponsors
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Sun Pharmaceutical Industries Limited
INDUSTRY
Responsible Party
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Locations
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Clinical Research Center
Memphis, Tennessee, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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C-13-305-002
Identifier Type: -
Identifier Source: org_study_id