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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02121301
Other study ID # 13-110-0006
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date April 2014
Est. completion date June 2014

Study information

Verified date October 2020
Source Mitotech, SA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Single-center, double-masked, randomized, placebo-controlled study comprising 4 visits over the course of approximately 5 weeks. The study included a 1-week placebo (SkQ1 vehicle) run-in period between Visit 1 and Visit 2, and approximately 28 days of twice daily (BID) dosing (Visit 2 - Visit 4). Qualified subjects were randomized 1:1:1 to receive either 1.55 µg/mL SkQ1 ophthalmic solution, 0.155 µg/mL SkQ1 ophthalmic solution, or placebo (vehicle of SkQ1 ophthalmic solution). The following primary endpoints were tested: - Corneal Fluorescein staining in the inferior region Pre-CAE at Visit 4 (Day 29), as measured by the Ora Calibra Scale in the worst eye at baseline; - Worst dry eye symptom (ocular discomfort, dryness, or grittiness - as determined from subject diary data recorded during the 1-week run-in period between Visit 1 and Visit 2) evaluated over the seven days preceding Visit 4 (not including day of visit) during the treatment period.


Recruitment information / eligibility

Status Completed
Enrollment 91
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Be male or female of any race, at least 18 years of age - Have provided written informed consent - Have a reported history of dry eye syndrome - Have a history of use or desire to use eye drops for dry eye Exclusion Criteria: - Have any clinically significant eye findings that require therapeutic treatment or may interfere with study parameters - Have previously had LASIK surgery within the last 12 months - Have used Restasis® within 30 days of Visit 1 - Be a woman who is pregnant, nursing or planning a pregnancy - Be unwilling to submit a urine pregnancy test if of childbearing potential - Have a known allergy and/or sensitivity to the test article or its components, including the preservative benzalkonium chloride - Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1 - Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study

Study Design


Intervention

Drug:
Low Dose 0.155µg/mL SkQ1 ophthalmic solution
eyedrops
High Dose 1.55µg/mL SkQ1 ophthalmic solution
eyedrops
Placebo (Vehicle) opthalmic solution
eyedrops

Locations

Country Name City State
United States Lawrence General Hospital Andover Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Mitotech, SA ORA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Inferior Corneal Fluorescein Staining 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 Day 29
Primary Worst Symptom Based on Diary Data 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. Day 29
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