Clinical Trial To Determine The Effectiveness And Safety Of Topical Insulin In Dry Eye (NCT05692739) | Clinical Trial Compass
CompletedPhase 4
Clinical Trial To Determine The Effectiveness And Safety Of Topical Insulin In Dry Eye
Spain116 participantsStarted 2022-10-19
Plain-language summary
This is a parallel randomized controlled trial for the treatment of dry eye disease. The main objective is to investigate the efficacy and safety of the use of insulin eye drops in the control of moderate-severe dry eye disease. Topical insulin drops will be compared to the current gold standard treatment, cyclosporin and placebo (artificial tears).
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:
* Patients older than 18 years
* Dry eye disease diagnosis
* Treatment with artificial tears or hyaluronic acid gels for at least 3 months
* Signed informed consent by the patient
* Staining equal to or greater than Oxford II
Exclusion Criteria:
* Under 18 years old
* Corneal staining under Oxford II
* Treatment for dry eye disease other than artificial tears or hyaluronic acid gels
* Severe dry eye disease that requires immediate treatment
* Eye surgery in the last 6 months
* Other concomitant corneal pathology, eyelid malpositions, nasolacrimal drainage abnormalities, blinking alterations
* Contact lenses
* Other treatment besides artificial tears or hyaluronic acid gels
* Visual acuity less than 0.1
* Allergy or intolerance to any of the components included in the study
* Modifications in systemic immunosuppressive treatment
* Pregnancy or lactation
* Women of childbearing age who do not use a highly effective contraceptive method
* History of alcohol or drug abuse
* Participation in another clinical trial in the last 30 days
* Systemic pathology (cardiopulmonary pathology, connective tissue disorders, neurological or psychiatric pathology) or baseline situation of the patient that does not allow the examination (such as mental or psychomotor retardation)
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
What they're measuring
1
Change of corneal staining from baseline to 6 months after treatment
Timeframe: From baseline to 6 months after treatment