A Clinical Study to Assess the Safety and Efficacy of an Ophthalmic Solution (SkQ1) in the Treatm… (NCT02121301) | Clinical Trial Compass
CompletedPhase 2
A Clinical Study to Assess the Safety and Efficacy of an Ophthalmic Solution (SkQ1) in the Treatment of Dry Eye Syndrome (DES)
United States91 participantsStarted 2014-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested an eye drop called SkQ1 for dry eye syndrome and measured both corneal staining and patient-reported symptoms — has this research led to any approved treatments or follow-up studies I should know about, given that this was only a Phase 2 trial?
2Since this was a Phase 2 study, what do we know so far about whether SkQ1 has been shown to be safe and well-tolerated in the eye, and are there any side effects that came up in the results?
3The trial tracked something called inferior corneal fluorescein staining, which measures surface damage to the eye — can you explain how serious my current level of corneal staining is, and whether a treatment targeting that specific marker might be relevant for me?
4The study also measured 'worst symptom' based on daily diary entries — does that approach reflect the kinds of symptoms I'm experiencing, and how does that compare to how my dry eye would be evaluated under standard care?
5Since this trial is completed but SkQ1 may not be widely available yet, are there currently approved treatments for keratoconjunctivitis sicca that work through a similar mechanism, or would it make more sense to start with existing standard-of-care options first?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.