Status:
COMPLETED
Efficacy and Safety Study of a Steroid/Antibiotic Combination Eyedrop to Treat Non-Bacterial Blepharitis
Lead Sponsor:
Sun Pharmaceutical Industries Limited
Conditions:
Blepharitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the clinical efficacy and safety of ISV-502 compared to AzaSite® alone, Dexamethasone alone, and vehicle in the treatment of subjects with Non-bacterial Blepha...
Eligibility Criteria
Inclusion
- Are at least 18 years of age at Visit 1 (Day 1, Baseline) of either sex and any race.
- Signature of the subject or legally authorized representative on the Informed Consent Form.
- 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. Post menopausal is defined as having no menses for at least 12 consecutive months.
- Additional inclusion criteria also apply.
Exclusion
- Have known sensitivity or poor tolerance to any component of the Investigational Drug.
- Have an acute ocular infection (bacterial, viral or fungal) or active ocular inflammation other than Blepharitis in the study eye.
- Have used topical corticosteroid medications or topical ophthalmic solutions that the investigator feels may interfere with the study parameters.
- Have used any non-diagnostic topical ophthalmic solutions in the study eye.
- Be currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive urine pregnancy test.
- Currently suffer from alcohol and/or drug abuse.
- Have prior (within 30 days of beginning 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.
- Additional exclusion criteria also apply.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
917 Patients enrolled
Trial Details
Trial ID
NCT01408082
Start Date
October 1 2011
End Date
June 1 2013
Last Update
November 19 2021
Active Locations (45)
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1
Arizona Eye Center
Chandler, Arizona, United States
2
Arizona Center for Clinical Trials LLC
Phoenix, Arizona, United States
3
Cornea Consultants of Arizona
Phoenix, Arizona, United States
4
Lugene Eye Institute
Glendale, California, United States