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

NCT02121301 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2020-11-02

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

  • Keratoconjunctivitis Sicca

Interventions

DRUG

Low Dose 0.155µg/mL SkQ1 ophthalmic solution

eyedrops

DRUG

High Dose 1.55µg/mL SkQ1 ophthalmic solution

eyedrops

DRUG

Placebo (Vehicle) opthalmic solution

eyedrops

Sponsors & Collaborators

  • ORA, Inc.

    collaborator INDUSTRY

  • Mitotech, SA

    lead INDUSTRY

Principal Investigators

  • Gail Torkildsen, MD · Lawrence General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2014-06-30
Completion
2014-06-30

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 NCT02121301 on ClinicalTrials.gov