Clinical trial NCT04206020: Vehicle-Controlled Study of SkQ1 as Treatment for Dry-eye Syndrome
Official title: A Phase 3, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Study of Safety and Efficacy of SkQ1 Ophthalmic Solution in the Environment and the Controlled Adverse Environmental (CAE®) Model for the Treatment of Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Syndrome
Keywords: Dry Eye
Dry Eye Syndrome
SkQ1
KCS
Keratoconjunctivitis
Lead sponsor: Mitotech, SA
Sponsor class: INDUSTRY
Collaborators: name: ORA, Inc.
First posted: 2019-12-20
Enrollment: 610
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment Parallel-group study SkQ1 Ophthalmic Solution versus placebo (vehicle) solution
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate whether SkQ1 Ophthalmic Solution is safe and effective compared to Vehicle for the treatment of the signs and symptoms of dry eye syndrome.

Detailed description: Multi-center, double-masked, randomized, placebo-controlled study comprising 5 visits over the course of approximately 9 weeks. Qualified subjects are randomized 1:1 to receive either SkQ1 Ophthalmic Solution, or Placebo (vehicle of SkQ1 Ophthalmic Solution).

The Primary Endpoints are:

Change from Baseline (Visit 2) to Visit 5 of Ocular Discomfort;

Change from Baseline (Visit 2) to Visit 5 of conjunctival fluorescein staining (sum of temporal and nasal regions)

Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age;
* Provide written informed consent;
* Have a subject reported history of dry eye;
* Have a history of use of eye drops for dry eye symptoms;
* Ocular Discomfort;
* Schirmer's Test score;
* Have corneal fluorescein staining ;
* Have lissamine green conjunctival Staining;
* Have a conjunctival redness;

Exclusion Criteria:

* Have been previously exposed to previous SkQ1 Ophthalmic Solution treatment;
* Have any clinically significant slit lamp findings at Visit 1;
* Be diagnosed with an ongoing ocular infection or active ocular inflammation at Visit 1;
* Have had any ocular and/or lid surgeries within 6 months of Visit 1 or any planned over the study period;
* Have an uncontrolled systemic disease;
* Be a woman who is pregnant, nursing or planning a pregnancy;
* Be a woman of childbearing potential who is not using an acceptable means of birth control;
* Have a known allergy and/or sensitivity to the study drug or its components;
* 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;
* Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1;

Primary outcomes:
measure: Ocular Discomfort Scale
timeFrame: From baseline to Day 57
measure: Conjunctival Fluorescein Staining
timeFrame: From baseline to Day 57
Secondary outcomes:
Other outcomes:
Locations:
city: Sun City West
country: United States
facility: Arizona Eye Institute and Cosmetic Laser
state: Arizona
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
city: San Antonio
country: United States
facility: Eye Clinics of South Texas
state: Texas
city: Lynchburg
country: United States
facility: Piedmont Eye Center
state: Virginia
Study officials:
affiliation: Mitotech, SA
name: Lawrence T Friedhoff, MD, PhD
role: STUDY_CHAIR
References: