Using insulin eye drops to treat dry eye disease
Ensayo Clínico Para Determinar La Eficacia Y Seguridad Del Colirio De Insulina En El Tratamiento Del Ojo Seco En Pacientes Con Ojo Seco
This study is testing if insulin eye drops can help people with moderate to severe dry eye disease feel better compared to standard treatments like cyclosporin and fake tears.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital San Carlos, Madrid Academic / other |
| Locations | 1 site (Madrid) |
| Trial ID | NCT05692739 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness and safety of topical insulin eye drops for patients suffering from moderate to severe dry eye disease. It is a parallel randomized controlled trial comparing insulin drops to the current standard treatments, which include cyclosporin and placebo artificial tears. Patients will be recruited from an ophthalmology clinic in Madrid and will be monitored for their response to the treatment over the course of the trial.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with moderate to severe dry eye disease who have been using artificial tears or hyaluronic acid gels for at least three months.
Not a fit: Patients with severe dry eye disease requiring immediate treatment or those with other significant ocular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new and effective option for patients suffering from dry eye disease.
How similar studies have performed: While the use of insulin in ocular treatments is novel, similar studies exploring alternative therapies for dry eye have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients older than 18 years * Dry eye disease diagnosis * Treatment with artificial tears or hyaluronic acid gels for at least 3 months * Signed informed consent by the patient * Staining equal to or greater than Oxford II Exclusion Criteria: * Under 18 years old * Corneal staining under Oxford II * Treatment for dry eye disease other than artificial tears or hyaluronic acid gels * Severe dry eye disease that requires immediate treatment * Eye surgery in the last 6 months * Other concomitant corneal pathology, eyelid malpositions, nasolacrimal drainage abnormalities, blinking alterations * Contact lenses * Other treatment besides artificial tears or hyaluronic acid gels * Visual acuity less than 0.1 * Allergy or intolerance to any of the components included in the study * Modifications in systemic immunosuppressive treatment * Pregnancy or lactation * Women of childbearing age who do not use a highly effective contraceptive method * History of alcohol or drug abuse * Participation in another clinical trial in the last 30 days * Systemic pathology (cardiopulmonary pathology, connective tissue disorders, neurological or psychiatric pathology) or baseline situation of the patient that does not allow the examination (such as mental or psychomotor retardation)
Where this trial is running
Madrid
- Hospital Clinico San Carlos — Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Barbara Burgos Blasco, MD, PhD — Hospital Clinico San Carlos
- Study coordinator: Barbara Burgos Blasco, MD, PhD
- Email: barbara.burgos@salud.madrid.org
- 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.