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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

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.

Condition or disease Intervention/treatment Phase
Keratoconjunctivitis Sicca Drug: Low Dose 0.155µg/mL SkQ1 ophthalmic solution Drug: High Dose 1.55µg/mL SkQ1 ophthalmic solution Drug: Placebo (Vehicle) opthalmic solution Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Arm Intervention/treatment
Experimental: Low Dose SkQ1
Drug: Low Dose 0.155µg/mL SkQ1 ophthalmic solution administered twice daily for 28 days
Drug: Low Dose 0.155µg/mL SkQ1 ophthalmic solution
eyedrops

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

Placebo Comparator: Placebo (vehicle)
Drug: Placebo (vehicle) ophthalmic solution administered twice daily for 28 days
Drug: Placebo (Vehicle) opthalmic solution
eyedrops




Primary Outcome Measures :
  1. 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

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02121301


Locations
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United States, Massachusetts
Lawrence General Hospital
Andover, Massachusetts, United States, 01841
Sponsors and Collaborators
Mitotech, SA
ORA, Inc.
Investigators
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Principal Investigator: Gail Torkildsen, MD Lawrence General Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mitotech, SA
ClinicalTrials.gov Identifier: NCT02121301    
Other Study ID Numbers: 13-110-0006
First Posted: April 23, 2014    Key Record Dates
Results First Posted: October 14, 2020
Last Update Posted: November 2, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mitotech, SA:
Dry Eye
Dry Eye Syndrome
SkQ1
Keratoconjunctivitis
Dry Eye Disease
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Pharmaceutical Solutions
Ophthalmic Solutions