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Trial record 1 of 1 for:    VISTA-2
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Vehicle-Controlled Study of SkQ1 as Treatment for Dry-eye Syndrome (VISTA-2)

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ClinicalTrials.gov Identifier: NCT04206020
Recruitment Status : Recruiting
First Posted : December 20, 2019
Last Update Posted : February 11, 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 Solution is safe and effective compared to Vehicle for the treatment of the signs and symptoms of dry eye syndrome.

Condition or disease Intervention/treatment Phase
Dry Eye Syndrome Drug: SkQ1 Vehicle Solution Drug: SkQ1 Ophthalmic Solution 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 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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
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
Official Title: 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
Actual Study Start Date : December 3, 2019
Estimated Primary Completion Date : September 15, 2020
Estimated Study Completion Date : September 15, 2020

Arm Intervention/treatment
Placebo Comparator: Placebo Comparator: SkQ1 Vehicle
Vehicle for SkQ1 Ophthalmic Solution
Drug: SkQ1 Vehicle Solution
SkQ1 Ophthalmic Solution Vehicle
Other Name: Vehicle for SkQ1

Active Comparator: SkQ1
SkQ1 Ophthalmic Solution
Drug: SkQ1 Ophthalmic Solution
SkQ1 Ophthalmic Solution




Primary Outcome Measures :
  1. Ocular Discomfort Scale [ Time Frame: From baseline to Day 57 ]
    Change of Ocular Discomfort Scale

  2. Conjunctival Fluorescein Staining [ Time Frame: From baseline to Day 57 ]
    Change of Conjunctival Fluroscein Staining (sum of temporal and nasal regions)


Secondary Outcome Measures :
  1. Ocular Discomfort Scale [ Time Frame: From Baseline to Day 29 ]
    Change from Baseline of Ocular Discomfort on Day 29

  2. 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

  3. Tear Film Breakup Time During Controlled Adverse Environment (CAE®) [ Time Frame: Day 57 ]
    Tear film break-up time pre- to post-CAE®

  4. Corneal Fluorescein Staining [ Time Frame: Baseline to Day 29 ]
    Change from baseline of corneal fluorescein staining in central region on Day 29



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
Gender Based Eligibility:   Yes
Gender Eligibility Description:   self-representation
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 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;

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): NCT04206020


Contacts
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Contact: Melissa Gould, MS (978) 685-8900 ext 9568 mgould@oraclinical.com
Contact: Michael Watson (978) 685-8900 ext 9446 mwatson@oraclinical.com

Locations
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United States, Arizona
Arizona Eye Institute and Cosmetic Laser Recruiting
Sun City West, Arizona, United States, 85375
Contact: Mckenna White    480-889-1211    m.white@prgresearch.com   
United States, Massachusetts
Andover Eye Associates Recruiting
Andover, Massachusetts, United States, 01810
Contact: Paul J Hicks, Jr.    978-475-0705    phicks@oraclinical.com   
United States, Texas
Eye Clinics of South Texas Recruiting
San Antonio, Texas, United States, 78209
Contact: Carrie Iverson    701-478-0061    carrie@bergstromeye.com   
United States, Virginia
Piedmont Eye Center Recruiting
Lynchburg, Virginia, United States, 24502
Contact: Susan Shelton    434-947-3984    SShelton@piedmonteye.com   
Sponsors and Collaborators
Mitotech, SA
ORA, Inc.
Investigators
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Study Chair: Lawrence T Friedhoff, MD, PhD Mitotech, SA

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Responsible Party: Mitotech, SA
ClinicalTrials.gov Identifier: NCT04206020    
Other Study ID Numbers: 19-110-0011
First Posted: December 20, 2019    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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