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

NCT ID: NCT02121301

Last Updated: 2020-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2014-06-30

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.

Conditions

Keratoconjunctivitis Sicca

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Low Dose SkQ1

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

Group Type: EXPERIMENTAL

Low Dose 0.155µg/mL SkQ1 ophthalmic solution

Intervention Type: DRUG

eyedrops

High Dose SkQ1

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

Group Type: EXPERIMENTAL

High Dose 1.55µg/mL SkQ1 ophthalmic solution

Intervention Type: DRUG

eyedrops

Placebo (vehicle)

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

Group Type: PLACEBO_COMPARATOR

Placebo (Vehicle) opthalmic solution

Intervention Type: DRUG

eyedrops

Interventions

Low Dose 0.155µg/mL SkQ1 ophthalmic solution

eyedrops

Intervention Type: DRUG

High Dose 1.55µg/mL SkQ1 ophthalmic solution

eyedrops

Intervention Type: DRUG

Placebo (Vehicle) opthalmic solution

eyedrops

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ORA, Inc.

INDUSTRY

Sponsor Role: collaborator

Mitotech, SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gail Torkildsen, MD

Role: PRINCIPAL_INVESTIGATOR

Lawrence General Hospital

Locations

Lawrence General Hospital

Andover, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26733410 (View on PubMed)

Other Identifiers

13-110-0006

Identifier Type: -

Identifier Source: org_study_id