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

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ClinicalTrials.gov Identifier: NCT02121301
Recruitment Status : Completed
First Posted : April 23, 2014
Results First Posted : October 14, 2020
Last Update Posted : November 2, 2020
Sponsor:
Collaborator:
ORA, Inc.
Information provided by (Responsible Party):
Mitotech, SA

Tracking Information
First Submitted Date  ICMJE April 17, 2014
First Posted Date  ICMJE April 23, 2014
Results First Submitted Date  ICMJE October 7, 2016
Results First Posted Date  ICMJE October 14, 2020
Last Update Posted Date November 2, 2020
Study Start Date  ICMJE April 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2020)
  • Inferior Corneal Fluorescein Staining [ Time Frame: Day 29 ]
    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
  • Worst Symptom Based on Diary Data [ Time Frame: Day 29 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 22, 2014)
  • Fluorescein Staining [ Time Frame: Day 29 ]
  • Worst Dry Eye Symptom [ Time Frame: Day 29 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: April 22, 2014)
Number of participants with Adverse events [ Time Frame: Day 29 ]
 
Descriptive Information
Brief Title  ICMJE A Clinical Study to Assess the Safety and Efficacy of an Ophthalmic Solution (SkQ1) in the Treatment of Dry Eye Syndrome (DES)
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Keratoconjunctivitis Sicca
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Low Dose SkQ1
    Drug: Low Dose 0.155µg/mL SkQ1 ophthalmic solution administered twice daily for 28 days
    Intervention: Drug: Low Dose 0.155µg/mL SkQ1 ophthalmic solution
  • Experimental: High Dose SkQ1
    Drug: High Dose 1.55µg/mL SkQ1 ophthalmic solution administered twice daily for 28 days
    Intervention: Drug: High Dose 1.55µg/mL SkQ1 ophthalmic solution
  • Placebo Comparator: Placebo (vehicle)
    Drug: Placebo (vehicle) ophthalmic solution administered twice daily for 28 days
    Intervention: Drug: Placebo (Vehicle) opthalmic solution
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 19, 2020)
91
Original Estimated Enrollment  ICMJE
 (submitted: April 22, 2014)
90
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02121301
Other Study ID Numbers  ICMJE 13-110-0006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mitotech, SA
Study Sponsor  ICMJE Mitotech, SA
Collaborators  ICMJE ORA, Inc.
Investigators  ICMJE
Principal Investigator: Gail Torkildsen, MD Lawrence General Hospital
PRS Account Mitotech, SA
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP