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Study of SkQ1 as Treatment for Dry-eye Syndrome (VISTA-1)

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ClinicalTrials.gov Identifier: NCT03764735
Recruitment Status : Active, not recruiting
First Posted : December 5, 2018
Last Update Posted : January 4, 2019
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
Dry Eye Syndrome Drug: Low Dose - SkQ1 Drug: High dose - SkQ1 Drug: SkQ1 (Vehicle) Phase 3

Detailed Description:

Multi-center, double-masked, randomized, placebo-controlled study comprising 5 visits over the course of approximately 9 weeks. Qualified subjects are randomized 1:1:1 to receive either High Dose SkQ1 ophthalmic solution, Low Dose SkQ1 ophthalmic solution, or Placebo (vehicle of SkQ1 ophthalmic solution).

The Primary Endpoints are:

Change from Baseline (Visit 2) to Visit 5 in Corneal Fluorescein Staining;

Change from Baseline (Visit 2) to Visit 5 in Grittiness Symptom


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 451 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel-group study of two strengths of ophthalmic solution versus placebo solution
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of SkQ1 Ophthalmic Solution for the Treatment of Dry Eye Syndrome
Actual Study Start Date : October 27, 2018
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : April 30, 2019

Arm Intervention/treatment
Placebo Comparator: SkQ1 Vehicle
SkQ1 (Vehicle)
Drug: SkQ1 (Vehicle)
Vehicle for SkQ1 ophthalmic solution

Active Comparator: Low Dose - SkQ1
Low-dose ophthalmic solution
Drug: Low Dose - SkQ1
SkQ1 Low dose ophthalmic solution
Other Name: Vizomitin(R)

Active Comparator: High Dose - SkQ1
High-dose ophthalmic solution
Drug: High dose - SkQ1
SkQ1 High Dose ophthalmic solution




Primary Outcome Measures :
  1. Central Corneal Staining change from baseline [ Time Frame: From baseline to Day 57 ]
    Change of Corneal Fluorescein Staining

  2. Grittiness change from baseline [ Time Frame: From baseline to Day 57 ]
    Change of patient-reported grittiness


Secondary Outcome Measures :
  1. Corneal and conjunctival staining [ Time Frame: Through Day 57 ]
    Corneal and conjunctival fluorescein staining on a 0-4 point scale in all regions through Day 57 and following exposure to a controlled adverse environment (CAE®) on Day 57 only. Regions: central, superior, inferior, temporal, nasal, corneal sum, conjunctival sum and total

  2. Lissamine green staining [ Time Frame: Through Day 57 ]
    Lissamine green staining in all regions Scale; regions: central, superior, inferior, temporal, nasal, corneal sum, and total

  3. Schirmer's Test [ Time Frame: Through Day 57 ]
    Unanesthetized Schirmer's Test

  4. Ocular Discomfort and 4-symptom Questionaire [ Time Frame: Through Day 57 ]
    Ocular Discomfort & 4-Symptom Questionnaire

  5. OSDI [ Time Frame: Through Day 57 ]
    Ocular Surface Disease Index (OSDI)

  6. Ocular Discomfort [ Time Frame: Through Day 57 ]
    Ocular Discomfort Scale

  7. Symptom Diary [ Time Frame: Through Day 57 ]
    Subject Symptom Daily Diary

  8. Tear Film Breakup Time [ Time Frame: Through Day 57 ]
    Tear Film Breakup Time

  9. Conjunctival Redness [ Time Frame: Through Day 57 ]
    Conjunctival Redness Scale Conjunctival Redness Scale

  10. Lid Margin Redness [ Time Frame: Through Day 57 ]
    Lid Margin Redness Scale



Information from the National Library of Medicine

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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 at least 18 years of age;
  • Provide written informed consent;
  • Have a subject reported history of dry eye;
  • Have a history of use of eye drops for dry eye symptoms ;
  • Ocular Discomfort;
  • Schirmer's Test score;
  • Have corneal fluorescein staining ;
  • Have lissamine green conjunctival Staining ;
  • Have a conjunctival redness;

Exclusion Criteria:

  • Have participated in the previous SkQ1 ophthalmic solution Phase 2 treatment study;
  • Have any clinically significant slit lamp findings at Visit 1;
  • Be diagnosed with an ongoing ocular infection or active ocular inflammation at Visit 1;
  • Have had any ocular and/or lid surgeries within 6 months of Visit 1 or any planned over the study period;
  • Have an uncontrolled systemic disease;
  • Be a woman who is pregnant, nursing or planning a pregnancy;
  • Be a woman of childbearing potential who is not using an acceptable means of birth control;
  • Have a known allergy and/or sensitivity to the study drug or its components ;
  • 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;
  • Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1;

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): NCT03764735


Locations
United States, Arizona
Cornea & Cataract Consultants of Arizona
Phoenix, Arizona, United States, 85032
United States, California
Eye Research Foundation
Newport Beach, California, United States, 92663
United States, Kentucky
Eye Care Insititute
Louisville, Kentucky, United States, 40206
United States, Maine
Central Maine Eye Care
Lewiston, Maine, United States, 04240
United States, Massachusetts
Andover Eye Associates
Andover, Massachusetts, United States, 01810
United States, North Carolina
Vita Eye Clinic
Shelby, North Carolina, United States, 28150
United States, Tennessee
Total Eye Care, PA
Memphis, Tennessee, United States, 38119
Sponsors and Collaborators
Mitotech, SA
ORA, Inc.
Investigators
Study Chair: Lawrence T Friedhoff, MD, PhD Mitotech, SA

Responsible Party: Mitotech, SA
ClinicalTrials.gov Identifier: NCT03764735     History of Changes
Other Study ID Numbers: 18-110-0004
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mitotech, SA:
Dry Eye
Dry Eye Syndrome
SkQ1
KCS
Keratoconjunctivitis

Additional relevant MeSH terms:
Syndrome
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Disease
Pathologic Processes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions
Ophthalmic Solutions