Dry Eye SyndromePhase 3VISTA-2NCT04206020

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

A Phase 3 study testing SkQ1 Ophthalmic Solution in people with Dry Eye Syndrome, run by Mitotech, SA at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dry Eye Syndrome
What is being tested?: SkQ1 Ophthalmic Solution
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 610 participants
Where: 4 sitesUnited States
Study dates: 20 Dec 2019to 6 Oct 2020
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

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Have corneal fluorescein staining ;
Have lissamine green conjunctival Staining;
Have a conjunctival redness;

Who cannot join

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;

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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;

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Andover Eye Associates
Andover, Massachusetts, 01810
Piedmont Eye Center
Lynchburg, Virginia, 24502
Eye Clinics of South Texas
San Antonio, Texas, 78209
Arizona Eye Institute and Cosmetic Laser
Sun City West, Arizona, 85375

Other trials in United States

About this study

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

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.

Read the 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)

Conditions: Dry Eye Syndrome
Being tested: SkQ1 Vehicle Solution, SkQ1 Ophthalmic Solution
Keywords: Dry Eye, Dry Eye Syndrome, SkQ1, KCS, Keratoconjunctivitis
Medical subject headings: Dry Eye Syndromes, Keratoconjunctivitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SkQ1 Vehicle SolutionDrug
Also called Vehicle for SkQ1
SkQ1 Ophthalmic Solution Vehicle
SkQ1 Ophthalmic SolutionDrug
Also called Visomitin
SkQ1 Ophthalmic Solution

Study groups in NCT04206020
Study group	Role	What they receive
Placebo Comparator: SkQ1 Vehicle	Placebo comparator	Vehicle for SkQ1 Ophthalmic Solution Receives: Drug: SkQ1 Vehicle Solution
SkQ1	Active comparator	SkQ1 Ophthalmic Solution Receives: Drug: SkQ1 Ophthalmic Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

Ocular Discomfort Scale
Change of Ocular Discomfort Scale, scale ranged from 0 to 4 with 0 = No Discomfort and 4 = Constant Discomfort.
Measured: From baseline to Day 57
Conjunctival Fluorescein Staining
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
Measured: From baseline to Day 57

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Dec 20196 Oct 2020

First posted20 Dec 2019
Study start20 Dec 2019
Primary completion6 Oct 2020
Study completion6 Oct 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dry Eye SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Parallel Assignment Parallel-group study SkQ1 Ophthalmic Solution versus placebo (vehicle) solution
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 610 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04206020
Sponsor's protocol ID: 19-110-0011
Acronym: VISTA-2
Status last verified: Dec 2021
First submitted: 18 Dec 2019
Last updated: 19 Jan 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dry Eye Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04206020
Acronym / sponsor ID: VISTA-2 / 19-110-0011
Conditions: Dry Eye Syndrome
Keywords: Dry Eye, Dry Eye Syndrome, SkQ1, KCS, Keratoconjunctivitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 610 participants (actual)
Lead sponsor: Mitotech, SAIndustry (pharma, biotech, devices)
Collaborators: ORA, Inc.
Study start: 20 Dec 2019 (actual)
Primary completion: 6 Oct 2020 (actual)
Study completion: 6 Oct 2020 (actual)
First posted: 20 Dec 2019 (actual)
Results: Posted 19 Jan 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Parallel Assignment Parallel-group study SkQ1 Ophthalmic Solution versus placebo (vehicle) solution

Arm	Type	Receives
Placebo Comparator: SkQ1 Vehicle	Placebo comparator	Drug: SkQ1 Vehicle SolutionVehicle for SkQ1 Ophthalmic Solution
SkQ1	Active comparator	Drug: SkQ1 Ophthalmic SolutionSkQ1 Ophthalmic Solution

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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;

Key exclusion criteria (10 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SkQ1 Vehicle SolutionAlso: Vehicle for SkQ1SkQ1 Ophthalmic Solution Vehicle	Drug	Placebo Comparator: SkQ1 Vehicle
SkQ1 Ophthalmic SolutionAlso: VisomitinSkQ1 Ophthalmic Solution	Drug	SkQ1

Primary outcome

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

Results and safety

Results posted to the registry on 19 Jan 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Comparator: SkQ1 Vehicle	306	298
SkQ1 Ophthalmic Solution	304	297

Primary outcome: Ocular Discomfort Scale

Time frame: From baseline to Day 57. Mean (Standard Deviation). Unit: units on a scale

Measure	Placebo Comparator: SkQ1 Vehicle n = 306	SkQ1 Ophthalmic Solution n = 304
Value	-0.6 (1.36)	-0.6 (1.34)

Primary outcome: Conjunctival Fluorescein Staining

Time frame: From baseline to Day 57. Mean (Standard Deviation). Unit: units on a scale

Measure	Placebo Comparator: SkQ1 Vehicle n = 251	SkQ1 Ophthalmic Solution n = 250
Value	-0.63 (1.087)	-0.69 (1.150)

Adverse events

Time frame: From Day -7 through end of study (Day 57). Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Comparator: SkQ1 Vehicle	2 of 306 (0.7%)	19 of 306 (6.2%)	0 of 306
SkQ1 Ophthalmic Solution	2 of 304 (0.7%)	20 of 304 (6.6%)	0 of 304

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lawrence T Friedhoff, MD, PhD study chair

Mitotech, SA

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SkQ1 Ophthalmic Solution in people with Dry Eye Syndrome, run by Mitotech, SA at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ocular Discomfort Scale (time frame: From baseline to Day 57). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04206020.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2022.