NCT06017362 Clinical Trial to Determine the Efficacy and Safety of Insulin Eye Drops in Dry Eye in Patients with Topical Hypotensors
| NCT ID | NCT06017362 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Barbara Burgos Blasco |
| Condition | Dry Eye |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-02-08 |
| Primary Completion | 2026-02-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2023-02-08 with a primary completion date of 2026-02-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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). The main question aims to answer whether glaucoma patients treated with topical hypotensors could benefit from the use of insulin eye drops for the treatment of dry eye. Participants will be assigned to one of the two treatment arms and will be required to attend four follow-up visits (baseline, 1, 3, and 6 months).
Eligibility Criteria
Inclusion 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 Exclusion Criteria: * Uncontrolled glaucoma with expected changes in antihypertensive treatment in the next 6 months * 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 * 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.
Contact & Investigator
Barbara Burgos Blasco, MD, PhD
PRINCIPAL INVESTIGATOR
Hospital Clinico San Carlos
Frequently Asked Questions
Who can join the NCT06017362 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dry Eye. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06017362 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06017362 currently recruiting?
Yes, NCT06017362 is actively recruiting participants. Contact the research team at bburgos171@hotmail.com for enrollment information.
Where is the NCT06017362 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT06017362 clinical trial?
NCT06017362 is sponsored by Barbara Burgos Blasco. The principal investigator is Barbara Burgos Blasco, MD, PhD at Hospital Clinico San Carlos. The trial plans to enroll 100 participants.