Who is sponsoring NCT02121301?

NCT02121301 is sponsored by Mitotech, SA.

What drugs are being tested in NCT02121301?

Interventions in NCT02121301: Low Dose 0.155µg/mL SkQ1 ophthalmic solution, High Dose 1.55µg/mL SkQ1 ophthalmic solution, Placebo (Vehicle) opthalmic solution.

What condition does NCT02121301 study?

NCT02121301 studies Keratoconjunctivitis Sicca.

Is NCT02121301 still recruiting?

NCT02121301 is currently completed. Last updated 12 October 2020.

Are results published for NCT02121301?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-10-12 · How we verify

NCT02121301

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase 2, Single-Center, Randomized, Double-Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of SkQ1 Ophth Sol'n in the Environment and During Challenge in the Controlled Adverse Environment (CAE) Model for the Treatment of DES

Completed Phase 2 Results posted Last updated 12 October 2020

What this trial tests

Phase 2 trial testing Low Dose 0.155µg/mL SkQ1 ophthalmic solution in Keratoconjunctivitis Sicca in 91 participants. Completed in 1 June 2014.

Timeline

1 April 2014

Primary endpoint
1 June 2014

1 June 2014

Quick facts

Lead sponsor	Mitotech, SA
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	91
Start date	1 April 2014
Primary completion	1 June 2014
Estimated completion	1 June 2014
Sites	1 location across United States

Drugs / interventions tested

Low Dose 0.155µg/mL SkQ1 ophthalmic solution — full drug profile →
High Dose 1.55µg/mL SkQ1 ophthalmic solution — full drug profile →
Placebo (Vehicle) opthalmic solution

Conditions studied

Keratoconjunctivitis Sicca — all drugs for Keratoconjunctivitis Sicca →

Sponsor

Mitotech, SA — full company profile →

Who can join

18 and older, any sex, with Keratoconjunctivitis Sicca. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Inferior Corneal Fluorescein Staining
Time frame: Day 29
The dry eye sign primary efficacy variable of corneal fluorescein staining of the inferior region of the eye measured on a 0-4 point scale where 0 = no staining and 4 = most staining between treatment arms at day 29
Worst Symptom Based on Diary Data
Time frame: Day 29
Worst dry eye symptom (as determined from subject diary data recorded during the 1-week run-in period) evaluated over the seven days preceding Day 29 during the treatment period. The scale was on a 0-5 range where 0= no symptoms and 5= worst symptoms measured for a number of dry eye symptoms.

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):

Mitochondria-Targeted Triphenylphosphonium-Based Compounds: Syntheses, Mechanisms of Action, and Therapeutic and Diagnostic Applications.
Zielonka J, Joseph J, Sikora A, Hardy M, et al · · 2017 · cited 1088× · PMID 28654243 · DOI 10.1021/acs.chemrev.7b00042
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
Mitochondria-Targeted Drugs.
Zinovkin RA, Zamyatnin AA. · · 2019 · cited 148× · PMID 30479224 · DOI 10.2174/1874467212666181127151059
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
SkQ1 Ophthalmic Solution for Dry Eye Treatment: Results of a Phase 2 Safety and Efficacy Clinical Study in the Environment and During Challenge in the Controlled Adverse Environment Model.
Petrov A, Perekhvatova N, Skulachev M, Stein L, et al · · 2016 · cited 79× · PMID 26733410 · DOI 10.1007/s12325-015-0274-5
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
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
Oxidative Stress and Antioxidant Therapy in Pulmonary Hypertension.
Poyatos P, Gratacós M, Samuel K, Orriols R, et al · · 2023 · cited 23× · PMID 37237872 · DOI 10.3390/antiox12051006

Verify or expand the search:

Other Mitotech, SA trials

Trials by the same sponsor.

NCT04206020 — Vehicle-Controlled Study of SkQ1 as Treatment for Dry-eye Syndrome · Phase 3 · completed
NCT03764735 — Study of SkQ1 as Treatment for Dry-eye Syndrome · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02121301 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mitotech, SA
Last refreshed: 12 October 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02121301.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing