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

Sun Pharma

Status and phase: Completed; Phase 3

Conditions: Blepharitis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01408082

C-10-502-004

Details and patient eligibility

About

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.

Enrollment: 917 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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917 participants in 4 patient groups, including a placebo group

ISV-502

Experimental group

Treatment:

Drug: ISV-502 (1.0% azithromycin and 0.1% dexamethasone combined)

AzaSite

Active Comparator group

Treatment:

Drug: Azasite

Dexamethasone

Active Comparator group

Treatment:

Drug: Dexamethasone

Vehicle

Placebo Comparator group

Treatment:

Other: Vehicle