About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Insulin
- Artificial tear
Treatment groups
Sponsors and collaborators
Barbara Burgos Blasco
Lead sponsor
Hospital San Carlos, Madrid
Sponsor institution