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Vehicle-Controlled Study of SkQ1 as Treatment for Dry-eye Syndrome (VISTA-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04206020
Recruitment Status : Completed
First Posted : December 20, 2019
Results First Posted : January 19, 2022
Last Update Posted : January 19, 2022
Sponsor:
Collaborator:
ORA, Inc.
Information provided by (Responsible Party):
Mitotech, SA

Tracking Information
First Submitted Date  ICMJE December 18, 2019
First Posted Date  ICMJE December 20, 2019
Results First Submitted Date  ICMJE December 20, 2021
Results First Posted Date  ICMJE January 19, 2022
Last Update Posted Date January 19, 2022
Actual Study Start Date  ICMJE December 20, 2019
Actual Primary Completion Date October 6, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2021)
  • Ocular Discomfort Scale [ Time Frame: From baseline to Day 57 ]
    Change of Ocular Discomfort Scale, scale ranged from 0 to 4 with 0 = No Discomfort and 4 = Constant Discomfort.
  • Conjunctival Fluorescein Staining [ Time Frame: From baseline to Day 57 ]
    Change of Conjunctival Fluorescein Staining (sum of temporal and nasal regions), scale in each region ranged from 0 to 4 with 0 = No Staining and 4 = Confluent Staining
Original Primary Outcome Measures  ICMJE
 (submitted: December 18, 2019)
  • Ocular Discomfort Scale [ Time Frame: From baseline to Day 57 ]
    Change of Ocular Discomfort Scale
  • Conjunctival Fluorescein Staining [ Time Frame: From baseline to Day 57 ]
    Change of Conjunctival Fluroscein Staining (sum of temporal and nasal regions)
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2019)
  • Ocular Discomfort Scale [ Time Frame: From Baseline to Day 29 ]
    Change from Baseline of Ocular Discomfort on Day 29
  • Conjunctival Fluorescein Staining [ Time Frame: From Baseline to Day 43 ]
    Change from baseline of conjunctival fluorescein staining (sum of temporal and nasal regions) to Day 43
  • Tear Film Breakup Time During Controlled Adverse Environment (CAE®) [ Time Frame: Day 57 ]
    Tear film break-up time pre- to post-CAE®
  • Corneal Fluorescein Staining [ Time Frame: Baseline to Day 29 ]
    Change from baseline of corneal fluorescein staining in central region on Day 29
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vehicle-Controlled Study of SkQ1 as Treatment for Dry-eye Syndrome
Official Title  ICMJE A Phase 3, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Study of Safety and Efficacy of SkQ1 Ophthalmic Solution in the Environment and the Controlled Adverse Environmental (CAE®) Model for the Treatment of Dry Eye Syndrome
Brief Summary The purpose of this study is to evaluate whether SkQ1 Ophthalmic Solution is safe and effective compared to Vehicle for the treatment of the signs and symptoms of dry eye syndrome.
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 to receive either SkQ1 Ophthalmic Solution, or Placebo (vehicle of SkQ1 Ophthalmic Solution).

The Primary Endpoints are:

Change from Baseline (Visit 2) to Visit 5 of Ocular Discomfort;

Change from Baseline (Visit 2) to Visit 5 of conjunctival fluorescein staining (sum of temporal and nasal regions)

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallel Assignment Parallel-group study SkQ1 Ophthalmic Solution versus placebo (vehicle) solution
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dry Eye Syndrome
Intervention  ICMJE
  • Drug: SkQ1 Vehicle Solution
    SkQ1 Ophthalmic Solution Vehicle
    Other Name: Vehicle for SkQ1
  • Drug: SkQ1 Ophthalmic Solution
    SkQ1 Ophthalmic Solution
    Other Name: Visomitin
Study Arms  ICMJE
  • Placebo Comparator: Placebo Comparator: SkQ1 Vehicle
    Vehicle for SkQ1 Ophthalmic Solution
    Intervention: Drug: SkQ1 Vehicle Solution
  • Active Comparator: SkQ1
    SkQ1 Ophthalmic Solution
    Intervention: Drug: SkQ1 Ophthalmic Solution
Publications * Not Provided

*   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: August 16, 2020)
610
Original Estimated Enrollment  ICMJE
 (submitted: December 18, 2019)
600
Actual Study Completion Date  ICMJE October 6, 2020
Actual Primary Completion Date October 6, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 been previously exposed to previous SkQ1 Ophthalmic Solution treatment;
  • 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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: self-representation
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 NCT04206020
Other Study ID Numbers  ICMJE 19-110-0011
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Mitotech, SA
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Mitotech, SA
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE ORA, Inc.
Investigators  ICMJE
Study Chair: Lawrence T Friedhoff, MD, PhD Mitotech, SA
PRS Account Mitotech, SA
Verification Date December 2021

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