Keratoconjunctivitis Sicca Clinical Trial
Official title:
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
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 |
Verified date | October 2020 |
Source | Mitotech, SA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Lawrence General Hospital | Andover | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Mitotech, SA | ORA, Inc. |
United States,
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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