Phase 2
Completed N=91
A Clinical Study to Assess the Safety and Efficacy of an Ophthalmic Solution (SkQ1) in the Treatment of Dry Eye Syndrome (DES)
Keratoconjunctivitis Sicca
Source: ClinicalTrials.gov NCT02121301 ↗
Enrolled (actual)
91
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcomePrimary: Inferior Corneal Fluorescein Staining — 2.40; 2.07; 2.11 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Inferior Corneal Fluorescein Staining |
2.40; 2.07; 2.11 | — |
| PRIMARY Worst Symptom Based on Diary Data |
2.54; 2.52; 2.39 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02121301). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.