Ensayo clínico Para Determinar la Eficacia y Seguridad Del Colirio de Insulina en el Tratamiento Del Ojo Seco en Pacientes Con Hipotensores tópicos

22/457-EC_M

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).

2023-02-08

2025-02-08

2025-02-08

Recruiting

Early phase I

100

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

2023-09-06