Dry Eye SyndromePhase 3VISTA-1NCT03764735

Study of SkQ1 as Treatment for Dry-eye Syndrome

A Phase 3 study testing Low Dose - SkQ1 and High dose - SkQ1 in people with Dry Eye Syndrome, run by Mitotech, SA at 7 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 solutions are safe and effective compared to placebo 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?: Low Dose - SkQ1 and High dose - SkQ1
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 452 participants
Where: 7 sitesUnited States
Study dates: 6 Dec 2018to 9 Feb 2019
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 participated in the previous SkQ1 ophthalmic solution Phase 2 treatment study;
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;

Show all 10Show fewer

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

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Andover Eye Associates
Andover, Massachusetts, 01810
Central Maine Eye Care
Lewiston, Maine, 04240
Eye Care Insititute
Louisville, Kentucky, 40206
Total Eye Care, PA
Memphis, Tennessee, 38119
Eye Research Foundation
Newport Beach, California, 92663
Cornea & Cataract Consultants of Arizona
Phoenix, Arizona, 85032
Vita Eye Clinic
Shelby, North Carolina, 28150

Other trials in United States

About this study

Official title: A Phase 3, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of SkQ1 Ophthalmic Solution for the Treatment of Dry Eye Syndrome

The purpose of this study is to evaluate whether SkQ1 ophthalmic solutions are safe and effective compared to placebo 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 1:1:1 to receive either High Dose SkQ1 ophthalmic solution, Low Dose SkQ1 ophthalmic solution, or Placebo (vehicle of SkQ1 ophthalmic solution).

The Primary Endpoints are:

Change from Baseline (Visit 2) to Visit 5 in Corneal Fluorescein Staining;

Change from Baseline (Visit 2) to Visit 5 in Grittiness Symptom

Conditions: Dry Eye Syndrome
Being tested: Low Dose - SkQ1, High dose - SkQ1, SkQ1 (Vehicle)
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.

Low Dose - SkQ1Drug
Also called Visomitin
SkQ1 Low dose ophthalmic solution
High dose - SkQ1Drug
Also called Visomitin
SkQ1 High Dose ophthalmic solution
SkQ1 (Vehicle)Drug
Vehicle for SkQ1 ophthalmic solution

Study groups in NCT03764735
Study group	Role	What they receive
SkQ1 Vehicle	Placebo comparator	SkQ1 (Vehicle) Receives: Drug: SkQ1 (Vehicle)
Low Dose - SkQ1	Active comparator	Low-dose ophthalmic solution Receives: Drug: Low Dose - SkQ1
High Dose - SkQ1	Active comparator	High-dose ophthalmic solution Receives: Drug: High dose - SkQ1

What is being measured

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

Central Corneal Staining Change From Baseline
Change of Corneal Fluorescein Staining from baseline to Day 57, scale ranges from 0 to 4, where grade 0 = None, 4 = Severe
Measured: From baseline to Day 57
Grittiness Change From Baseline
Change of patient-reported grittiness from baseline to Day 57, scale ranges from 0 to 5 for each symptom, where 0 = None and 5 = Worst
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.

6 Dec 20189 Feb 2019

First posted5 Dec 2018
Study start6 Dec 2018
Primary completion9 Feb 2019
Study completion9 Feb 2019

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-group study of two strengths of ophthalmic solution versus placebo solution
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 452 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03764735
Sponsor's protocol ID: 18-110-0004
Acronym: VISTA-1
Status last verified: Dec 2021
First submitted: 30 Nov 2018
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 Clinical Study to Assess the Safety and Efficacy of SkQ1 Ophthalmic Solution for the Treatment of Dry Eye Syndrome
ClinicalTrials.gov ID: NCT03764735
Acronym / sponsor ID: VISTA-1 / 18-110-0004
Conditions: Dry Eye Syndrome
Keywords: Dry Eye, Dry Eye Syndrome, SkQ1, KCS, Keratoconjunctivitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 452 participants (actual)
Lead sponsor: Mitotech, SAIndustry (pharma, biotech, devices)
Collaborators: ORA, Inc.
Study start: 6 Dec 2018 (actual)
Primary completion: 9 Feb 2019 (actual)
Study completion: 9 Feb 2019 (actual)
First posted: 5 Dec 2018 (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 solutions are safe and effective compared to placebo 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 in Corneal Fluorescein Staining;

Change from Baseline (Visit 2) to Visit 5 in Grittiness Symptom

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3
Model description: Parallel-group study of two strengths of ophthalmic solution versus placebo solution

Arm	Type	Receives
SkQ1 Vehicle	Placebo comparator	Drug: SkQ1 (Vehicle)SkQ1 (Vehicle)
Low Dose - SkQ1	Active comparator	Drug: Low Dose - SkQ1Low-dose ophthalmic solution
High Dose - SkQ1	Active comparator	Drug: High dose - SkQ1High-dose 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 participated in the previous SkQ1 ophthalmic solution Phase 2 treatment study;
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
Low Dose - SkQ1Also: VisomitinSkQ1 Low dose ophthalmic solution	Drug	Low Dose - SkQ1
High dose - SkQ1Also: VisomitinSkQ1 High Dose ophthalmic solution	Drug	High Dose - SkQ1
SkQ1 (Vehicle)Vehicle for SkQ1 ophthalmic solution	Drug	SkQ1 Vehicle

Primary outcome

Central Corneal Staining Change From Baseline
Time frame: From baseline to Day 57
Change of Corneal Fluorescein Staining from baseline to Day 57, scale ranges from 0 to 4, where grade 0 = None, 4 = Severe
Grittiness Change From Baseline
Time frame: From baseline to Day 57
Change of patient-reported grittiness from baseline to Day 57, scale ranges from 0 to 5 for each symptom, where 0 = None and 5 = Worst

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
SkQ1 Vehicle	151	147
Low Dose - SkQ1	150	144
High Dose - SkQ1	151	147

Primary outcome: Central Corneal Staining Change From Baseline

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

Measure	SkQ1 Vehicle n = 151	Low Dose - SkQ1 n = 149	High Dose - SkQ1 n = 151
Value	-0.28 (0.773)	-0.3 (0.816)	-0.2 (0.763)

Primary outcome: Grittiness Change From Baseline

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

Measure	SkQ1 Vehicle n = 151	Low Dose - SkQ1 n = 149	High Dose - SkQ1 n = 151
Value	-0.42 (1.108)	-0.36 (1.176)	-0.43 (1.387)

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
SkQ1 Vehicle	1 of 151 (0.7%)	3 of 151 (2%)	0 of 151
Low Dose - SkQ1	3 of 149 (2%)	4 of 149 (2.7%)	0 of 149
High Dose - SkQ1	2 of 151 (1.3%)	3 of 151 (2%)	0 of 151

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

7 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 Low Dose - SkQ1 and High dose - SkQ1 in people with Dry Eye Syndrome, run by Mitotech, SA at 7 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 7 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?

Central Corneal Staining Change From Baseline (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 NCT03764735.

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.