Using insulin eye drops to treat dry eye in glaucoma patients
Ensayo Clínico Para Determinar La Eficacia Y Seguridad Del Colirio De Insulina En El Tratamiento Del Ojo Seco En Pacientes Con Hipotensores Tópicos
This study is testing if insulin eye drops can help people with glaucoma who also have dry eyes feel better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital San Carlos, Madrid Academic / other |
| Locations | 1 site (Madrid, Madrid) |
| Trial ID | NCT06017362 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness and safety of insulin eye drops for managing dry eye disease in patients who are already receiving topical hypotensive treatment for glaucoma. Participants will be randomly assigned to receive either insulin eye drops or a placebo (artificial tears) and will attend follow-up visits at baseline, 1, 3, and 6 months to assess their condition. The study is conducted in Madrid, where patients with dry eye and glaucoma will be recruited from an ophthalmology clinic. The primary focus is to determine if insulin eye drops can provide additional relief for dry eye symptoms in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with controlled ocular hypertension or glaucoma who also have a diagnosis of dry eye.
Not a fit: Patients with uncontrolled glaucoma or severe dry eye requiring immediate treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for glaucoma patients suffering from dry eye disease.
How similar studies have performed: While the use of insulin in eye drops is a novel approach, similar studies exploring alternative treatments for dry eye have shown varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Madrid, Madrid
- Hospital Clinico San Carlos — Madrid, Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Barbara Burgos Blasco, MD, PhD — Hospital Clinico San Carlos
- Study coordinator: Barbara Burgos Blasco, MD, PhD
- Email: bburgos171@hotmail.com
- Phone: +34 913303000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.