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Clinical Trial To Determine The Efficacy And Safety Of Insulin Eye Drops In Dry Eye In Patients With Topical Hypotensors
EU CTIS ID: 2024-518407-22-00
What this study is testing
The goal of this clinical trial is to evaluate the preliminary efficacy of the use of insulin eye drops in the control of dry eye disease in patients with topical hypotensors, compared to placebo (artificial tears).
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients who provide written informed consent and who are able and willing to comply with all scheduled study visits and procedures.
- Patients ≥ 18 years at the screening visit.
- Ocular hypertension or glaucoma controlled with hypotensive treatment
- Diagnosis of dry eye
You likely can't join if
- Uncontrolled glaucoma with expected changes in antihypertensive treatment in the next 6 months
- Patients with a history of allergy or hypersensitivity to the study medication or any of its excipients
- Modifications in systemic immunosuppressive treatment in the last 6 months
- History of alcohol or drug abuse
- Patients who have received an experimental drug or used an experimental medical device in the 30-day period prior to the screening visit.
- Systemic pathology (cardiopulmonary pathology, connective tissue disorders, neurological or psychiatric pathology) or situation of the patient that does not allow examination (such as mental or psychomotor retardation).
See the full eligibility criteria
- Patients who provide written informed consent and who are able and willing to comply with all scheduled study visits and procedures.
- Patients ≥ 18 years at the screening visit.
- Ocular hypertension or glaucoma controlled with hypotensive treatment
- Diagnosis of dry eye
- Uncontrolled glaucoma with expected changes in antihypertensive treatment in the next 6 months
- Patients with a history of allergy or hypersensitivity to the study medication or any of its excipients
- Modifications in systemic immunosuppressive treatment in the last 6 months
- History of alcohol or drug abuse
- Patients who have received an experimental drug or used an experimental medical device in the 30-day period prior to the screening visit.
- Systemic pathology (cardiopulmonary pathology, connective tissue disorders, neurological or psychiatric pathology) or situation of the patient that does not allow examination (such as mental or psychomotor retardation).
- Any other disease or condition that, at the discretion of the investigator, could constitute a risk to the participant or interfere with the results of the study.
- Changes in topical glaucoma treatment in the last 3 months
- Severe dry eye requiring immediate treatment
- Previous eye surgery, except cataract surgery more than 12 months ago
- Laser procedures less than 6 months ago
- Other concomitant ocular pathology: scarring disease of the ocular surface, uveitis, infection in the last 90 days, trauma in the last 90 days
- Eyelid disorders
- Use of contact lenses
- Other topical treatment other than dry eye and glaucoma
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.