Title

A Clinical Study to Assess the Safety and Efficacy of an Ophthalmic Solution (SkQ1) in the Treatment of Dry Eye Syndrome (DES)
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
  • Phase

    Phase 2
  • Study Type

    Interventional
  • Intervention/Treatment

    skq1 ...
  • Study Participants

    91
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.
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.
Study Started
Apr 30
2014
Primary Completion
Jun 30
2014
Study Completion
Jun 30
2014
Results Posted
Oct 14
2020
Last Update
Nov 02
2020

Drug Low Dose 0.155µg/mL SkQ1 ophthalmic solution

eyedrops

Drug High Dose 1.55µg/mL SkQ1 ophthalmic solution

eyedrops

Drug Placebo (Vehicle) opthalmic solution

eyedrops

Low Dose SkQ1 Experimental

Drug: Low Dose 0.155µg/mL SkQ1 ophthalmic solution administered twice daily for 28 days

High Dose SkQ1 Experimental

Drug: High Dose 1.55µg/mL SkQ1 ophthalmic solution administered twice daily for 28 days

Placebo (vehicle) Placebo Comparator

Drug: Placebo (vehicle) ophthalmic solution administered twice daily for 28 days

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

Summary

Low Dose SkQ1

High Dose SkQ1

Placebo (Vehicle)

All Events

Event Type Organ System Event Term Low Dose SkQ1 High Dose SkQ1 Placebo (Vehicle)

Inferior Corneal Fluorescein Staining

The dry eye sign primary efficacy variable of corneal fluorescein staining of the inferior region of the eye measured on a 0-4 point scale where 0 = no staining and 4 = most staining between treatment arms at day 29

Low Dose SkQ1

2.4
units on a scale (Mean)
Standard Deviation: 0.675

High Dose SkQ1

2.07
units on a scale (Mean)
Standard Deviation: 0.704

Placebo (Vehicle)

2.11
units on a scale (Mean)
Standard Deviation: 0.771

Worst Symptom Based on Diary Data

Worst dry eye symptom (as determined from subject diary data recorded during the 1-week run-in period) evaluated over the seven days preceding Day 29 during the treatment period. The scale was on a 0-5 range where 0= no symptoms and 5= worst symptoms measured for a number of dry eye symptoms.

Low Dose SkQ1

2.54
units on a scale (Mean)
Standard Deviation: 0.993

High Dose SkQ1

2.52
units on a scale (Mean)
Standard Deviation: 0.899

Placebo (Vehicle)

2.39
units on a scale (Mean)
Standard Deviation: 1.063

Total

91
Participants

Age, Continuous

62
years (Mean)
Standard Deviation: 10.68

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

Low Dose SkQ1

High Dose SkQ1

Placebo (Vehicle)

Drop/Withdrawal Reasons

Low Dose SkQ1

High Dose SkQ1

Placebo (Vehicle)