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Study of SkQ1 as Treatment for Dry-eye Syndrome

NCT03764735 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 452

Last updated 2022-01-19

Study results available
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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.

Conditions

  • Dry Eye Syndrome

Interventions

DRUG

Low Dose - SkQ1

SkQ1 Low dose ophthalmic solution

DRUG

High dose - SkQ1

SkQ1 High Dose ophthalmic solution

DRUG

SkQ1 (Vehicle)

Vehicle for SkQ1 ophthalmic solution

Sponsors & Collaborators

  • ORA, Inc.

    collaborator INDUSTRY

  • Mitotech, SA

    lead INDUSTRY

Principal Investigators

  • Lawrence T Friedhoff, MD, PhD · Mitotech, SA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-06
Primary Completion
2019-02-09
Completion
2019-02-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03764735 on ClinicalTrials.gov