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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-Masked, Parallel-Group, Comparative Study 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

Conditions
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Blepharitis

Intervention / Treatment
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* Drug: ISV-502 (1.0% azithromycin and 0.1% dexamethasone combined)
* Drug: Azasite
* Drug: Dexamethasone
* Other: Vehicle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ISV-502<br> | Drug: ISV-502 (1.0% azithromycin and 0.1% dexamethasone combined)<br>* Azithromycin and Dexamethasone twice daily for 2 weeks<br>* Other names: AzaSite Plus;|
| Active Comparator: AzaSite<br> | Drug: Azasite<br>* Azasite twice daily for 2 weeks<br>|
| Active Comparator: Dexamethasone<br> | Drug: Dexamethasone<br>* Dexamethasone twice daily for 2 weeks<br>|
| Placebo Comparator: Vehicle<br> | Other: Vehicle<br>* Vehicle twice daily for 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

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