Actively Recruiting
Clinical Trial to Determine the Efficacy and Safety of Insulin Eye Drops in Dry Eye in Patients with Topical Hypotensors
Led by Barbara Burgos Blasco · Updated on 2024-10-22
100
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official 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 able and willing to comply with all scheduled study visits and procedures
- Patients 18 years or older at the screening visit
- Diagnosed with 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 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 ocular diseases such as scarring of the ocular surface, uveitis, recent infection or trauma within the last 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 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 before screening
- Systemic diseases or conditions that prevent examination or pose risk
- Any other disease or condition that could interfere with the study or participant safety according to the investigator
AI-Screening
AI-Powered Screening
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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
CONTACT
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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