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

• Sponsor: Mitotech, SA (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04206020
• Collaborator: ORA, Inc. (Industry)
• Enrollment: 610
• Locations: 4
• Arms: 2
• Actual Duration (Months): 9.6
• Patients Per Site: 152.5
• Patients Per Site Per Month: 16

Study Details

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.

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)

Study Design

• Study Type: Interventional
• Actual Enrollment: 610 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel Assignment Parallel-group study SkQ1 Ophthalmic Solution versus placebo (vehicle) solutionParallel 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: Dec 20, 2019
• Actual Primary Completion Date: Oct 6, 2020
• Actual Study Completion Date: Oct 6, 2020

Arms and Interventions

Arm	Intervention/Treatment
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; Other Names: Visomitin

Outcome Measures

Primary Outcome Measures

1. Ocular Discomfort Scale [From baseline to Day 57]

   Change of Ocular Discomfort Scale, scale ranged from 0 to 4 with 0 = No Discomfort and 4 = Constant Discomfort.

2. Conjunctival Fluorescein Staining [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Eye Institute and Cosmetic Laser	Sun City West	Arizona	United States	85375
2	Andover Eye Associates	Andover	Massachusetts	United States	01810
3	Eye Clinics of South Texas	San Antonio	Texas	United States	78209
4	Piedmont Eye Center	Lynchburg	Virginia	United States	24502

Sponsors and Collaborators

• Mitotech, SA
• ORA, Inc.

Investigators

• Study Chair: Lawrence T Friedhoff, MD, PhD, Mitotech, SA

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 4, 2019

More Information

Publications

None provided.

• Responsible Party: Mitotech, SA
• ClinicalTrials.gov Identifier: NCT04206020
• Other Study ID Numbers: 19-110-0011
• First Posted: Dec 20, 2019
• Last Update Posted: Jan 19, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• 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: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome; Pharmaceutical Solutions; Ophthalmic Solutions

Study Results

Participant Flow

Arm/Group Title	Placebo Comparator: SkQ1 Vehicle	SkQ1 Ophthalmic Solution
Arm/Group Description	Vehicle for SkQ1 Ophthalmic Solution	SkQ1 Ophthalmic Solution (1.55µg/mL)
Period Title: Overall Study
STARTED	306	304
COMPLETED	298	297
NOT COMPLETED	8	7

Baseline Characteristics

Arm/Group Title	Placebo Comparator: SkQ1 Vehicle	SkQ1 Ophthalmic Solution	Total
Arm/Group Description	Vehicle for SkQ1 Ophthalmic Solution	SkQ1 Ophthalmic Solution (1.55µg/mL)	Total of all reporting groups
Overall Participants	306	304	610
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	166 54.2%	150 49.3%	316 51.8%
>=65 years	140 45.8%	154 50.7%	294 48.2%
Age (years) [Mean (Standard Deviation) ]
Mean (SD)	61.9 (11.92)	62.8 (12.58)	62.4 (12.25)
Sex: Female, Male (Count of Participants)
Female	223 72.9%	209 68.8%	432 70.8%
Male	83 27.1%	95 31.3%	178 29.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.3%	0 0%	1 0.2%
Asian	13 4.2%	11 3.6%	24 3.9%
Native Hawaiian or Other Pacific Islander	0 0%	2 0.7%	2 0.3%
Black or African American	50 16.3%	34 11.2%	84 13.8%
White	241 78.8%	253 83.2%	494 81%
More than one race	1 0.3%	3 1%	4 0.7%
Unknown or Not Reported	0 0%	1 0.3%	1 0.2%
Region of Enrollment (participants) [Number]
United States	306 100%	304 100%	610 100%
Ocular Discomfort Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.7 (1.06)	2.7 (0.98)	2.7 (1.02)

Outcome Measures

1. Primary Outcome

Title	Ocular Discomfort Scale
Description	Change of Ocular Discomfort Scale, scale ranged from 0 to 4 with 0 = No Discomfort and 4 = Constant Discomfort.
Time Frame	From baseline to Day 57

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo Comparator: SkQ1 Vehicle	SkQ1 Ophthalmic Solution
Arm/Group Description	Vehicle for SkQ1 Ophthalmic Solution	SkQ1 Ophthalmic Solution (1.55µg/mL)
Measure Participants	306	304
Mean (Standard Deviation) [units on a scale]	-0.6 (1.36)	-0.6 (1.34)

2. Primary Outcome

Title	Conjunctival Fluorescein Staining
Description	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
Time Frame	From baseline to Day 57

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo Comparator: SkQ1 Vehicle	SkQ1 Ophthalmic Solution
Arm/Group Description	Vehicle for SkQ1 Ophthalmic Solution	SkQ1 Ophthalmic Solution (1.55µg/mL)
Measure Participants	251	250
Mean (Standard Deviation) [units on a scale]	-0.63 (1.087)	-0.69 (1.150)

Adverse Events

Time Frame	From Day -7 through end of study (Day 57)
Arm/Group Title	Placebo Comparator: SkQ1 Vehicle		SkQ1 Ophthalmic Solution
Arm/Group Description	Vehicle for SkQ1 Ophthalmic Solution		SkQ1 Ophthalmic Solution (1.55µg/mL)
All Cause Mortality
	Placebo Comparator: SkQ1 Vehicle		SkQ1 Ophthalmic Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/306 (0%)		0/304 (0%)
Serious Adverse Events
	Placebo Comparator: SkQ1 Vehicle		SkQ1 Ophthalmic Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/306 (0.7%)		2/304 (0.7%)
Cardiac disorders
Atrial fibrillation	0/306 (0%)	0	1/304 (0.3%)	1
Atrioventricular block complete	1/306 (0.3%)	1	0/304 (0%)	0
Gastrointestinal disorders
Colitis ischaemic	0/306 (0%)	0	1/304 (0.3%)	1
Renal and urinary disorders
Nephrolithiasis	1/306 (0.3%)	1	0/304 (0%)	0
Other (Not Including Serious) Adverse Events
	Placebo Comparator: SkQ1 Vehicle		SkQ1 Ophthalmic Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/306 (6.2%)		20/304 (6.6%)
Eye disorders
Visual acuity reduced	6/306 (2%)	6	5/304 (1.6%)	5
General disorders
Instillation site pain	13/306 (4.2%)	18	15/304 (4.9%)	19

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Authorship and manuscript composition will reflect cooperation among all parties involved in the study. Authorship will be established before writing the manuscript. The study sponsor will have the final decision regarding the manuscript and publication.