Conditions: Keratoconjunctivitis Sicca
Keywords: Dry Eye Dry Eye Syndrome SkQ1 Keratoconjunctivitis Dry Eye Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 91
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate whether SkQ1 ophthalmic solutions are safe and effective compared to placebo for the treatment of the signs and symptoms of dry eye syndrome.

Detailed description:
Single-center, double-masked, randomized, placebo-controlled study comprising 4 visits over the course of approximately 5 weeks. The study included a 1-week placebo (SkQ1 vehicle) run-in period between Visit 1 and Visit 2, and approximately 28 days of twice daily (BID) dosing (Visit 2 - Visit 4). Qualified subjects were randomized 1:1:1 to receive either 1.55 µg/mL SkQ1 ophthalmic solution, 0.155 µg/mL SkQ1 ophthalmic solution, or placebo (vehicle of SkQ1 ophthalmic solution).

The following primary endpoints were tested:

* Corneal Fluorescein staining in the inferior region Pre-CAE at Visit 4 (Day 29), as measured by the Ora Calibra Scale in the worst eye at baseline;
* Worst dry eye symptom (ocular discomfort, dryness, or grittiness - as determined from subject diary data recorded during the 1-week run-in period between Visit 1 and Visit 2) evaluated over the seven days preceding Visit 4 (not including day of visit) during the treatment period.

Arms:
arm 1: Drug: Low Dose 0.155µg/mL SkQ1 ophthalmic solution administered twice daily for 28 days arm 2: Drug: High Dose 1.55µg/mL SkQ1 ophthalmic solution administered twice daily for 28 days arm 3: Drug: Placebo (vehicle) ophthalmic solution administered twice daily for 28 days

Interventions: intervention 1: Low Dose 0.155µg/mL SkQ1 ophthalmic solution intervention 2: High Dose 1.55µg/mL SkQ1 ophthalmic solution intervention 3: Placebo (Vehicle) opthalmic solution
Intervention descriptions: intervention 1: eyedrops intervention 2: eyedrops intervention 3: eyedrops

Protocol document: