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Recruiting NCT06017362

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

Phase IV Interventional Dry Eye Glaucoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Insulin, Artificial tear.
Who it may be relevant to
Registry conditions: Dry Eye, Glaucoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug Insulin
    Topical insulin 1UI/ml 4 times a day
  • Drug Artificial tear
    Artificial tears 4 times a day

Primary outcome measures

  • Changes in dry eye symptoms from baseline to 6 months after treatment time [Time frame: From baseline to 6 months after treatment]
Secondary outcome measures (7)
  • Change of corneal staining from baseline to 6 months after treatment [Time frame: From baseline to 6 months after treatment]
  • Change in corneal aesthesiometry from baseline to 6 months after treatment [Time frame: From baseline to 6 months after treatment]
  • Change in conjunctival hyperemia from baseline to 6 months after treatment [Time frame: From baseline to 6 months after treatment]
  • Change in non-invasive tear film break-up time from baseline to 6 months after treatment [Time frame: From baseline to 6 months after treatment]
  • Change in light dispersion from baseline to 6 months after treatment [Time frame: From baseline to 6 months after treatment]
  • Change in cytokine levels from baseline to 6 months after treatment [Time frame: From baseline to 6 months after treatment]
  • Change in therapeutic compliance from baseline to 6 months after treatment [Time frame: From baseline to 6 months after treatment]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Hospital Clinico San Carlos — Madrid

Identifiers

NCT: NCT06017362 · 22/457-EC_M

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗