Overview

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 AzaSiteĀ® 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.