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History of Changes for Study: NCT04206020
Vehicle-Controlled Study of SkQ1 as Treatment for Dry-eye Syndrome (VISTA-2)
Latest version (submitted December 20, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 18, 2019 None (earliest Version on record)
2 December 19, 2019 Conditions and Study Status
3 January 9, 2020 Contacts/Locations and Study Status
4 February 10, 2020 Contacts/Locations and Study Status
5 August 16, 2020 Recruitment Status, Study Status, Contacts/Locations and Study Design
6 December 20, 2021 Recruitment Status, Study Status, Outcome Measures, Document Section, Results, Arms and Interventions and Study Design
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Study NCT04206020
Submitted Date:  December 18, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: 19-110-0011
Brief Title: Vehicle-Controlled Study of SkQ1 as Treatment for Dry-eye Syndrome (VISTA-2)
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
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2019
Overall Status: Recruiting
Study Start: December 3, 2019
Primary Completion: September 15, 2020 [Anticipated]
Study Completion: September 15, 2020 [Anticipated]
First Submitted: December 18, 2019
First Submitted that
Met QC Criteria:
December 18, 2019
First Posted: December 20, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
December 18, 2019
Last Update Posted: December 20, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Mitotech, SA
Responsible Party: Sponsor
Collaborators: ORA, Inc.
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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)

Open or close this module Conditions
Conditions: Dry Eye Syndrome
Keywords: Dry Eye Dry Eye Syndrome SkQ1 KCS Keratoconjunctivitis
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Parallel Assignment Parallel-group study SkQ1 Ophthalmic Solution versus placebo (vehicle) solution
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 600 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Placebo Comparator: Placebo Comparator: SkQ1 Vehicle
Vehicle for SkQ1 Ophthalmic Solution
Drug: SkQ1 Vehicle Solution
SkQ1 Ophthalmic Solution Vehicle
Other Names:
  • Vehicle for SkQ1
Active Comparator: SkQ1
SkQ1 Ophthalmic Solution
Drug: SkQ1 Ophthalmic Solution
SkQ1 Ophthalmic Solution
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based: Yes
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;
Open or close this module Contacts/Locations
Central Contact Person: Melissa Gould, MS
Telephone: (978) 685-8900 Ext. 9568
Email: mgould@oraclinical.com
Central Contact Backup: Michael Watson
Telephone: (978) 685-8900 Ext. 9446
Email: mwatson@oraclinical.com
Study Officials: Lawrence T Friedhoff, MD, PhD
Study Chair
Mitotech, SA
Locations: United States, Massachusetts
Andover Eye Associates
[Recruiting]
Andover, Massachusetts, United States, 01810
Contact:Contact: Paul J Hicks, Jr. 978-475-0705 phicks@oraclinical.com
United States, Virginia
Piedmont Eye Center
[Recruiting]
Lynchburg, Virginia, United States, 24502
Contact:Contact: Susan Shelton 434-947-3984 SShelton@piedmonteye.com
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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