Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca (Emerald)

Sun Pharma

Status and phase

Completed

Phase 3

Conditions

Keratoconjunctivitis Sicca

Treatments

Drug: cyclosporine

Drug: vehicle of OTX-101

Study type

Interventional

Funder types

Industry

Identifiers

NCT02688556

OTX-101-2016-001

Details and patient eligibility

About

This is a randomized, double-masked, vehicle-controlled study of the safety and efficacy of OTX-101 (0.09% cyclosporine nanomicellar solution) in the treatment of keratoconjunctivitis sicca to be conducted at approximately 50 sites.

Enrollment

745 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

History of dry eye syndrome (KCS) for a period of at least 6 months
Clinical diagnosis of bilateral KCS
Lissamine green conjunctival staining sum score of ≥ 3 to ≤ 9 out of a total possible score of 12 (scoring excludes superior zones 2 and 4) in the same eye at both the Screening and Baseline Visits.
Global symptom score (SANDE) ≥ 40 mm at both the Screening and Baseline Visits
Corrected Snellen visual acuity (VA) of better than 20/200 in each eye.

Exclusion criteria

Use of cyclosporine ophthalmic emulsion 0.05% (Restasis®) within 3 months prior to the Screening Visit.
Previous treatment failure (lack of efficacy) with cyclosporine ophthalmic emulsion 0.05% (Restasis).
Diagnosis of Sjögren's disease ˃ 5 years prior to the Screening Visit.
Clinical diagnosis or any history of seasonal and/or perennial allergic conjunctivitis.
Use of systemic or topical medications within 7 days prior to the Screening Visit or during the study period that are known to cause dry eye.
Use of any topical ophthalmic medications, prescription (including anti-glaucoma medications) or over the counter (including artificial tears), other than the assigned study medication during the study period.
Current active eye disease other than dry wyw syndrome (i.e., any disease for which topical or systemic ophthalmic medication is necessary).
History of herpes keratitis.
Corneal transplant
Corneal refractive surgery within 6 months prior to the Screening Visit or postoperative refractive surgery symptoms of dryness that have not resolved.
Cataract surgery within 3 months prior to the Screening Visit.