Status:
RECRUITING
Clinical Trial to Determine the Efficacy and Safety of Insulin Eye Drops in Dry Eye in Patients with Topical Hypotensors
Lead Sponsor:
Barbara Burgos Blasco
Conditions:
Dry Eye
Glaucoma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 (art...
Detailed Description
Patients will be recruited in Madrid. Patients with dry eye disease and topical glaucoma treatment will be identified through the Ophthalmology clinic. They will be directly referred to a physician wh...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 8 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06017362
Start Date
February 8 2023
End Date
February 8 2026
Last Update
October 22 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Clinico San Carlos
Madrid, Madrid, Spain, 28040