Comparative Study to Evaluate ISV-305 Compared to Vehicle in Blepharitis Subjects
NCT ID: NCT01543490
Last Updated: 2021-11-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
558 participants
INTERVENTIONAL
2018-03-30
2020-02-04
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 2 weeks
Vehicle
DuraSite® 2 vehicle
Vehicle
Vehicle twice daily for 2 weeks
Interventions
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ISV-305
Dexamethasone in DuraSite® 2 twice daily for 2 weeks
Vehicle
Vehicle twice daily for 2 weeks
Eligibility Criteria
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Inclusion Criteria
* 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 (this applies to parent or caregiver for subjects too young to self-apply investigational product)
* 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 had eyelid surgery in the study eye within twelve (12) months prior to Visit 1 or plan to have eyelid surgery during the study
* Have an acute ocular infection (bacterial, viral or fungal) or active ocular inflammation other than blepharitis in the study eye
* Have used topical medications on the eyelids or topical ophthalmic corticosteroid medications or systemic use of a corticosteroid mediation within 14 days prior to dosing and/or plan to use them throughout the duration of the study
* Be currently pregnant, nursing, or planning a pregnancy; or be a woman who has a positive urine pregnancy test
* Have prior (within 30 days prior to dosing) 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
1 Year
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
Newport Beach, California, 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-12-305-001
Identifier Type: -
Identifier Source: org_study_id