Actively Recruiting
Clinical Trial to Determine the Efficacy and Safety of Insulin Eye Drops in Dry Eye Among Patients Using Topical Hypotensors
Led by Barbara Burgos Blasco · Updated on 2024-10-22
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the preliminary effectiveness of insulin eye drops for controlling dry eye disease in patients who use topical hypotensive medications for glaucoma or ocular hypertension. This clinical trial aims to determine whether glaucoma patients treated with these eye drops could benefit compared to using artificial tears. The study is a randomized, single-masked phase 4 trial sponsored by Barbara Burgos Blasco. Participants will be randomly assigned to one of two groups: one receiving topical insulin eye drops at a concentration of 1UI/ml four times daily, and the other receiving artificial tears four times daily as a placebo. The treatment period lasts six months, during which participants will attend follow-up visits at baseline, 1 month, 3 months, and 6 months. During the study, participants will undergo assessments including monitoring changes in dry eye symptoms, corneal staining, corneal sensitivity, conjunctival redness, tear film stability, light dispersion, cytokine levels, and treatment compliance from baseline through six months. These evaluations help researchers understand how the treatments impact dry eye disease. The total participation time includes the initial screening and the six-month treatment and follow-up period.
CONDITIONS
Brief Title
Clinical Trial to Determine the Efficacy and Safety of Insulin Eye Drops in Dry Eye in Patients with Topical Hypotensors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who provide written informed consent and are willing to comply with all study visits and procedures
- Patients aged 18 years or older at screening
- Diagnosis of ocular hypertension or glaucoma controlled with hypotensive treatment
- Diagnosis of dry eye disease
You will not qualify if you...
- Uncontrolled glaucoma with expected changes in antihypertensive treatment within 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 ocular diseases such as scarring, uveitis, infection, or recent trauma within 90 days
- Eyelid disorders
- Use of contact lenses
- Use of other topical treatments besides dry eye and glaucoma medications
- History of allergy or hypersensitivity to the study medication or its components
- Changes in systemic immunosuppressive treatment in the last 6 months
- History of alcohol or drug abuse
- Use of experimental drugs or devices within 30 days prior to screening
- Systemic diseases or conditions preventing examination, such as cardiopulmonary, connective tissue, neurological, or psychiatric disorders
- Any condition that the investigator considers a risk or could interfere with study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive either topical insulin or artificial tears 4 times a day to treat dry eye disease while continuing their topical hypotensive treatment.
Regular visits during treatment period
Trial Site Locations
Total: 1 location
1
Hospital Clinico San Carlos
Madrid, Madrid, Spain, 28040
Actively Recruiting
Research Team
B
Barbara Burgos Blasco, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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