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

NCT02121301 | Completed Phase 2 Results

• 1 other identifier: 13-110-0006
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Keratoconjunctivitis Sicca

Keywords

Dry Eye; Dry Eye Syndrome; SkQ1; Keratoconjunctivitis; Dry Eye Disease

Outcome Measures

Primary Outcomes (2)

• 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

  Day 29

• 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.

  Day 29

Study Arms (3)

Low Dose SkQ1

EXPERIMENTAL

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

Drug: Low Dose 0.155µg/mL SkQ1 ophthalmic solution

High Dose SkQ1

EXPERIMENTAL

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

Drug: High Dose 1.55µg/mL SkQ1 ophthalmic solution

Placebo (vehicle)

PLACEBO COMPARATOR

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

Drug: Placebo (Vehicle) opthalmic solution

Interventions

Low Dose 0.155µg/mL SkQ1 ophthalmic solution DRUG

eyedrops

Low Dose SkQ1

High Dose 1.55µg/mL SkQ1 ophthalmic solution DRUG

eyedrops

High Dose SkQ1

Placebo (Vehicle) opthalmic solution DRUG

eyedrops

Placebo (vehicle)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mitotech, SA: lead
• ORA, Inc.: collaborator

Study Sites (1)

Lawrence General Hospital

Andover, Massachusetts, 01841, United States

Location

Related Publications (1)

• 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.

  PMID: 26733410 DERIVED

MeSH Terms

Conditions

Keratoconjunctivitis Sicca; Dry Eye Syndromes; Keratoconjunctivitis

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Keratitis; Corneal Diseases; Lacrimal Apparatus Diseases

Results Point of Contact

• Title: Gosse B. Bruinsma
• Organization: Ciurem Pharma Inc

gbb@CIUREM.COM

613-866-9609

Study Officials

• Gail Torkildsen, MD

  Lawrence General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2014
• First Posted: April 23, 2014
• Study Start: April 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: November 2, 2020
• Results First Posted: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)