Study of SkQ1 as Treatment for Dry-eye Syndrome

Multi-center, double-masked, randomized, placebo-controlled study comprising 5 visits over
the course of approximately 9 weeks. Qualified subjects are randomized 1:1:1 to receive
either High Dose SkQ1 ophthalmic solution, Low Dose SkQ1 ophthalmic solution, or Placebo
(vehicle of SkQ1 ophthalmic solution).

The Primary Endpoints are:

Change from Baseline (Visit 2) to Visit 5 in Corneal Fluorescein Staining;

Change from Baseline (Visit 2) to Visit 5 in Grittiness Symptom

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 participated in the previous SkQ1 ophthalmic solution Phase 2 treatment study;

- 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;