Clinical Trial to Determine the Efficacy and Safety of Insulin Eye Drops in Dry Eye in Patients with Topical Hypotensors

Barbara Burgos Blasco

Status and phase: Enrolling; Phase 4

Conditions: Dry Eye; Glaucoma

Treatments: Drug: Artificial tear; Drug: Insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT06017362

22/457-EC_M

Details and patient eligibility

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).

Full 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 who is participating in this study.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

100 participants in 2 patient groups, including a placebo group

Insulin

Experimental group

Description:

Topical insulin 1UI/ml 4 times a day

Treatment:

Drug: Insulin

Placebo (artificial tears)

Placebo Comparator group

Description:

Artificial tears 4 times a day

Treatment:

Drug: Artificial tear