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

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: InSite Vision; Sun Pharma Global FZE
• Treatments: Azithromycin; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

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.