Blepharitis
Conditions
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.
Interventions
DRUGISV-502 (1.0% azithromycin and 0.1% dexamethasone combined)
Azithromycin and Dexamethasone twice daily for 2 weeks
DRUGAzasite
Azasite twice daily for 2 weeks
DRUGDexamethasone
Dexamethasone twice daily for 2 weeks
OTHERVehicle
Vehicle twice daily for 2 weeks
Sponsors
Sun Pharmaceutical Industries Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed