Clinical trial NCT02121301: A Clinical Study to Assess the Safety and Efficacy of an Ophthalmic Solution (SkQ1) in the Treatment of Dry Eye Syndrome (DES)
Official title: Phase 2, Single-Center, Randomized, Double-Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of SkQ1 Ophth Sol'n in the Environment and During Challenge in the Controlled Adverse Environment (CAE) Model for the Treatment of DES
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Keratoconjunctivitis Sicca
Keywords: Dry Eye
Dry Eye Syndrome
SkQ1
Keratoconjunctivitis
Dry Eye Disease
Lead sponsor: Mitotech, SA
Sponsor class: INDUSTRY
Collaborators: name: ORA, Inc.
First posted: 2014-04-23
Enrollment: 91
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: 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.

Eligibility criteria: Inclusion Criteria:

* Be male or female of any race, at least 18 years of age
* Have provided written informed consent
* Have a reported history of dry eye syndrome
* Have a history of use or desire to use eye drops for dry eye

Exclusion Criteria:

* Have any clinically significant eye findings that require therapeutic treatment or may interfere with study parameters
* Have previously had LASIK surgery within the last 12 months
* Have used Restasis® within 30 days of Visit 1
* Be a woman who is pregnant, nursing or planning a pregnancy
* Be unwilling to submit a urine pregnancy test if of childbearing potential
* Have a known allergy and/or sensitivity to the test article or its components, including the preservative benzalkonium chloride
* Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1
* Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study

Primary outcomes:
measure: Inferior Corneal Fluorescein Staining
timeFrame: Day 29
measure: Worst Symptom Based on Diary Data
timeFrame: Day 29
Secondary outcomes:
Other outcomes:
Locations:
city: Andover
country: United States
facility: Lawrence General Hospital
state: Massachusetts
Study officials:
affiliation: Lawrence General Hospital
name: Gail Torkildsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Petrov A, Perekhvatova N, Skulachev M, Stein L, Ousler G. SkQ1 Ophthalmic Solution for Dry Eye Treatment: Results of a Phase 2 Safety and Efficacy Clinical Study in the Environment and During Challenge in the Controlled Adverse Environment Model. Adv Ther. 2016 Jan;33(1):96-115. doi: 10.1007/s12325-015-0274-5. Epub 2016 Jan 5.