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NCT02121301 · ClinicalTrials.gov registry record · Phase 2

A Clinical Study to Assess the Safety and Efficacy of an Ophthalmic Solution (SkQ1) in the Treatment of Dry Eye Syndrome (DES)

A Phase 2 study, sponsored by Mitotech.

Completed
Registry status
Phase 2
Development phase
91
Enrollment target

NCT02121301: Completed Phase 2 study, sponsored by Mitotech.

NCT02121301 is a Phase 2 study that has completed, run by Mitotech. The registered enrollment target is 91 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02121301, a Phase 2 study, has completed, sponsored by Mitotech.

COMPLETED
Registry status
Phase 2
Development phase
91 participants
Enrollment target

Study 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.

Primary Outcome

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

Interventions

  • DRUG Low Dose 0.155µg/mL SkQ1 ophthalmic solution
  • DRUG High Dose 1.55µg/mL SkQ1 ophthalmic solution
  • DRUG Placebo (Vehicle) opthalmic solution

Trial Details

FieldValue
Enrollment Target 91 participants
Start Date 2014-04
Est. Completion 2014-06
Phase Phase 2
Mitotech

3 total trials

What the finished NCT02121301 record still lists

NCT02121301 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower).

The record links to 0 conditions, and to 3 interventions - of which Low Dose 0.155µg/mL SkQ1 ophthalmic solution is the first listed.

NCT02121301 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02121301 about?

NCT02121301 is a clinical study titled "A Clinical Study to Assess the Safety and Efficacy of an Ophthalmic Solution (SkQ1) in the Treatment of Dry Eye Syndrome (DES)". 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.

What is the current status of trial NCT02121301?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 91 participants. The study started on 2014-04. Estimated completion is 2014-06.

What interventions are being tested in trial NCT02121301?

The interventions under investigation include: Low Dose 0.155µg/mL SkQ1 ophthalmic solution (DRUG), High Dose 1.55µg/mL SkQ1 ophthalmic solution (DRUG), Placebo (Vehicle) opthalmic solution (DRUG).

Who is sponsoring clinical trial NCT02121301?

This trial is sponsored by Mitotech, which has 3 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02121301's enrollment target sits among peer trials

91 771st of 2000 higher than 1,229 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02121301, the US trial registry maintained by the National Library of Medicine. NCT02121301 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.