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NCT05692739
Clinical Trial To Determine The Effectiveness And Safety Of Topical Insulin In Dry Eye
Conditions: Dry Eye, Insulin
Sex: All
Ages: 18 Years – N/A
Phase: PHASE4
Enrollment: 120
Sponsor: Barbara Burgos Blasco
Location: Spain
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).
Eligibility Criteria
Inclusion Criteria:Patients older than 18 yearsDry eye disease diagnosisTreatment with artificial tears or hyaluronic acid gels for at least 3 monthsSigned informed consent by the patientStaining equal to or greater than Oxford IIExclusion Criteria:Under 18 years oldCorneal staining under Oxford IITreatment for dry eye disease other than artificial tears or hyaluronic acid gelsSevere dry eye disease that requires immediate treatmentEye surgery in the last 6 monthsOther concomitant corneal pathology, eyelid malpositions, nasolacrimal drainage abnormalities, blinking alterationsContact lensesOther treatment besides artificial tears or hyaluronic acid gelsVisual acuity less than 0.1Allergy or intolerance to any of the components included in the studyModifications in systemic immunosuppressive treatmentPregnancy or lactationWomen of childbearing age who do not use a highly effective contraceptive methodHistory of alcohol or drug abuseParticipation in another clinical trial in the last 30 daysSystemic 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)
Source: ClinicalTrials.gov (NCT05692739). StuddyBuddy aggregates publicly available trial information.