Efficacy and Safety Study of a Steroid/Antibiotic Combination Eyedrop to Treat Non-Bacterial Blepharitis

Phase 3

Completed

Interventions: Other: Vehicle
Drug: Azasite
Drug: ISV-502 (1.0% azithromycin and 0.1% dexamethasone combined)
Drug: Dexamethasone

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 Blepharitis.

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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.

Arm && Interventions

Group	Intervention	Description
Vehicle	Vehicle	-
AzaSite	Azasite	-
ISV-502	ISV-502 (1.0% azithromycin and 0.1% dexamethasone combined)	-
Dexamethasone	Dexamethasone	-

Primary Outcome Measures

Name	Time	Method
Clinical Resolution	Day 15	The primary efficacy endpoint for the comparison of ISV-502 and AzaSite is complete clinical resolution of signs and symptoms at Day 15.
Recurrence of Clinical Signs and Symptoms	6 Month	The primary efficacy endpoint for the comparison of ISV-502 and Dexamethasone is recurrence of clinical signs and symptoms by 6-Month Follow-up.

Secondary Outcome Measures

Name	Time	Method

Locations (41): Arizona Eye Center
🇺🇸
Chandler, Arizona, United States
Arizona Center for Clinical Trials LLC
🇺🇸
Phoenix, Arizona, United States
Cornea Consultants of Arizona
🇺🇸
Phoenix, Arizona, United States
Lugene Eye Institute
🇺🇸
Glendale, California, United States
United Medical Research Institute
🇺🇸
Inglewood, California, United States
Macy Eye Center
🇺🇸
Los Angeles, California, United States
North Valley Eye Medical Group, Inc.
🇺🇸
Mission Hills, California, United States
Eye Research Foundation
🇺🇸
Newport Beach, California, United States
North Bay Associates, Inc.
🇺🇸
Petaluma, California, United States
Martel Eye Medical Group
🇺🇸
Rancho Cordova, California, United States
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Arizona Eye Center
🇺🇸Chandler, Arizona, United States