This trial is active, not recruiting.

Condition keratoconjunctivitis sicca
Treatments cyclosporine, vehicle of otx-101
Phase phase 3
Sponsor Ocular Technologies SARL
Start date February 2016
End date December 2016
Trial size 700 participants
Trial identifier NCT02688556, OTX-101-2016-001


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
0.09% cyclosporine nanomicellar ophthalmic solution
cyclosporine Seciera
(Placebo Comparator)
vehicle of OTX-101
vehicle of otx-101

Primary Outcomes

Tear Production
time frame: 12 weeks

Secondary Outcomes

Conjunctival Staining
time frame: 12 weeks
Central corneal staining
time frame: 12 weeks
Symptom Score
time frame: 12 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Randomized, Multicenter, Double-Masked, Vehicle-Controlled Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Ocular Technologies SARL.