Clinical trial NCT06017362: Clinical Trial to Determine the Efficacy and Safety of Insulin Eye Drops in Dry Eye in Patients with Topical Hypotensors
Official title: Ensayo Clínico Para Determinar La Eficacia Y Seguridad Del Colirio De Insulina En El Tratamiento Del Ojo Seco En Pacientes Con Hipotensores Tópicos
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Dry Eye
Glaucoma
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (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).

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 who is participating in this study.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in dry eye symptoms from baseline to 6 months after treatment time
timeFrame: From baseline to 6 months after treatment
Secondary outcomes:
measure: Change of corneal staining from baseline to 6 months after treatment
timeFrame: From baseline to 6 months after treatment
measure: Change in corneal aesthesiometry from baseline to 6 months after treatment
timeFrame: From baseline to 6 months after treatment
measure: Change in conjunctival hyperemia from baseline to 6 months after treatment
timeFrame: From baseline to 6 months after treatment
measure: Change in non-invasive tear film break-up time from baseline to 6 months after treatment
timeFrame: From baseline to 6 months after treatment
measure: Change in light dispersion from baseline to 6 months after treatment
timeFrame: From baseline to 6 months after treatment
measure: Change in cytokine levels from baseline to 6 months after treatment
timeFrame: From baseline to 6 months after treatment
measure: Change in therapeutic compliance from baseline to 6 months after treatment
timeFrame: From baseline to 6 months after treatment
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
Study officials:
affiliation: Hospital Clinico San Carlos
name: Barbara Burgos Blasco, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: