NCT03764735: VISTA-1

Study of SkQ1 as Treatment for Dry-eye Syndrome

Completed Phase 3 Results posted Last updated 19 January 2022

What this trial tests

Phase 3 trial testing Low Dose - SkQ1 in Dry Eye Syndrome in 452 participants. Completed in 9 February 2019.

Timeline

6 December 2018

Primary endpoint
9 February 2019

9 February 2019

Quick facts

Lead sponsor	Mitotech, SA
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	452
Start date	6 December 2018
Primary completion	9 February 2019
Estimated completion	9 February 2019
Sites	7 locations across United States

Drugs / interventions tested

• Low Dose - SkQ1 — full drug profile →
• High dose - SkQ1 — full drug profile →
• SkQ1 (Vehicle)

Conditions studied

• Dry Eye Syndrome — all drugs for Dry Eye Syndrome →

Sponsor

Mitotech, SA — full company profile →

Who can join

18 and older, any sex, with Dry Eye Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Central Corneal Staining Change From Baseline Primary · 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

Group	Value	95% CI
SkQ1 Vehicle	-0.28	± 0.773
Low Dose - SkQ1	-0.3	± 0.816
High Dose - SkQ1	-0.2	± 0.763

Grittiness Change From Baseline Primary · 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

Group	Value	95% CI
SkQ1 Vehicle	-0.42	± 1.108
Low Dose - SkQ1	-0.36	± 1.176
High Dose - SkQ1	-0.43	± 1.387

Adverse events — posted to ClinicalTrials.gov

Time frame: From Day -7 through end of study (Day 57). Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

SkQ1 Vehicle

Serious: 1/151 (1%)

Deaths: 0/151

Low Dose - SkQ1

Serious: 3/149 (2%)

Deaths: 0/149

High Dose - SkQ1

Serious: 2/151 (1%)

Deaths: 0/151

Serious adverse events (6 terms)

Reaction	System	SkQ1 Vehicle	Low Dose - SkQ1	High Dose - SkQ1
Ovarian cancer	Reproductive system and breast disorders	—	—	—
Peripheral arterial occlusive disorder	Vascular disorders	—	—	—
Osteomyelitis	Infections and infestations	—	—	—
Colitis	Gastrointestinal disorders	—	—	—
Procedural pain	Surgical and medical procedures	—	—	—
Migraine	Nervous system disorders	—	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	SkQ1 Vehicle	Low Dose - SkQ1	High Dose - SkQ1
Instillation site pain	General disorders	—	—	—
Visual acuity reduced	Eye disorders	—	—	—

Most-reported serious reactions: Ovarian cancer, Peripheral arterial occlusive disorder, Osteomyelitis, Colitis, Procedural pain, Migraine.

Data from ClinicalTrials.gov NCT03764735 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mitochondrial dysfunction: mechanisms and advances in therapy.
   Zong Y, Li H, Liao P, Chen L, et al · · 2024 · cited 614× · PMID 38744846 · DOI 10.1038/s41392-024-01839-8
2. Mitochondria-Targeted Antioxidants: A Step towards Disease Treatment.
   Jiang Q, Yin J, Chen J, Ma X, et al · · 2020 · cited 123× · PMID 33354280 · DOI 10.1155/2020/8837893
3. Mitochondria-Targeted Antioxidants, an Innovative Class of Antioxidant Compounds for Neurodegenerative Diseases: Perspectives and Limitations.
   Fields M, Marcuzzi A, Gonelli A, Celeghini C, et al · · 2023 · cited 63× · PMID 36835150 · DOI 10.3390/ijms24043739
4. Targeting mitochondrial quality control: new therapeutic strategies for major diseases.
   Hong WL, Huang H, Zeng X, Duan CY. · · 2024 · cited 38× · PMID 39164792 · DOI 10.1186/s40779-024-00556-1
5. Potential of Mitochondria-Targeted Antioxidants to Prevent Oxidative Stress in Pancreatic <i>β</i>-cells.
   Plecitá-Hlavatá L, Engstová H, Ježek J, Holendová B, et al · · 2019 · cited 24× · PMID 31249641 · DOI 10.1155/2019/1826303
6. Experimental Pharmacotherapy for Dry Eye Disease: A Review.
   Baiula M, Spampinato S. · · 2021 · cited 20× · PMID 33790661 · DOI 10.2147/jep.s237487
7. The Mitochondrion: A Promising Target for Kidney Disease.
   Tanriover C, Copur S, Ucku D, Cakir AB, et al · · 2023 · cited 19× · PMID 36839892 · DOI 10.3390/pharmaceutics15020570
8. Cytotoxicity and Mitochondrial Effects of Phenolic and Quinone-Based Mitochondria-Targeted and Untargeted Antioxidants on Human Neuronal and Hepatic Cell Lines: A Comparative Analysis.
   Fernandes C, Videira AJC, Veloso CD, Benfeito S, et al · · 2021 · cited 12× · PMID 34827603 · DOI 10.3390/biom11111605