Clinical trial NCT02688556: Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
Official title: A Randomized, Multicenter, Double-Masked, Vehicle-Controlled Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Keratoconjunctivitis Sicca
Keywords: KCS
dry eye
cyclosporine
Lead sponsor: Sun Pharmaceutical Industries Limited
Sponsor class: INDUSTRY
First posted: 2016-02-23
Enrollment: 745
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Tear Production
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Conjunctival Staining
timeFrame: Baseline and 12 weeks
measure: Central Corneal Staining
timeFrame: Baseline and 12 weeks
measure: Symptom Score
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Rancho Cordova
country: United States
facility: Martel Eye Medical Group
state: California
city: Edgewood
country: United States
facility: Cincinnati Eye Institute
state: Kentucky
city: New York
country: United States
facility: Fifth Avenue Eye Associates
state: New York
Study officials:
References: