Dry Eye, Insulin
Conditions
Brief summary
This is a parallel randomized controlled trial for the treatment of dry eye disease. The main objective is to investigate the efficacy and safety of the use of insulin eye drops in the control of moderate-severe dry eye disease. Topical insulin drops will be compared to the current gold standard treatment, cyclosporin and placebo (artificial tears).
Detailed description
Patients will be recruited in Madrid. Patients with dry eye disease and no topical treatment other than artificial tears will be identified through the Ophthalmology clinic. They will be directly referred to a physician who is participating in this study.
Interventions
DRUGInsulin
see arm description
DRUGCyclosporins
see arm description
DRUGArtificial tears
see arm description
Sponsors
Barbara Burgos Blasco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
This will be a randomized controlled trial for the treatment of dry eye disease with three arms: topical insulin, topical cyclosporin (gold standard) and artificial tears (placebo)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of corneal staining from baseline to 6 months after treatment | From baseline to 6 months after treatment | Corneal staining will be evaluated on the slit-lamp and on slit-lamp images (masked evaluator) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in dry eye symptoms from baseline to 6 months after treatment time | From baseline to 6 months after treatment | Dry eye symptoms will be evaluated using OSDI |
| Changes in esthesiometry from baseline to 6 months after treatment time | From baseline to 6 months after treatment | Esthesiometry will be evaluated using an esthesiometer |
| Changes in tear rupture time from baseline to 6 months after treatment time | From baseline to 6 months after treatment | Tear rupture time will be evaluated using the Keratograph (Oculus) |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORBarbara Burgos Blasco, MD, PhD
Hospital Clinico San Carlos
Outcome results
None listed