Clinical trial NCT05692739: Clinical Trial to Determine the Effectiveness and Safety of Topical Insulin in Dry Eye
Official title: Ensayo Clínico Para Determinar La Eficacia Y Seguridad Del Colirio De Insulina En El Tratamiento Del Ojo Seco En Pacientes Con Ojo Seco
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Dry Eye
Insulin
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Change of corneal staining from baseline to 6 months after treatment
timeFrame: From baseline to 6 months after treatment
Secondary outcomes:
measure: Changes in dry eye symptoms from baseline to 6 months after treatment time
timeFrame: From baseline to 6 months after treatment
measure: Changes in esthesiometry from baseline to 6 months after treatment time
timeFrame: From baseline to 6 months after treatment
measure: Changes in tear rupture time from baseline to 6 months after treatment time
timeFrame: From baseline to 6 months after treatment
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
Study officials:
affiliation: Hospital Clinico San Carlos
name: Barbara Burgos Blasco, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Diaz-Valle D, Burgos-Blasco B, Rego-Lorca D, Puebla-Garcia V, Perez-Garcia P, Benitez-Del-Castillo JM, Herrero-Vanrell R, Vicario-de-la-Torre M, Gegundez-Fernandez JA. Comparison of the efficacy of topical insulin with autologous serum eye drops in persistent epithelial defects of the cornea. Acta Ophthalmol. 2022 Jun;100(4):e912-e919. doi: 10.1111/aos.14997. Epub 2021 Aug 18.
citation: Diaz-Valle D, Burgos-Blasco B, Gegundez-Fernandez JA, Garcia-Caride S, Puebla-Garcia V, Pena-Urbina P, Benitez-Del-Castillo JM. Topical insulin for refractory persistent corneal epithelial defects. Eur J Ophthalmol. 2021 Sep;31(5):2280-2286. doi: 10.1177/1120672120958307. Epub 2020 Sep 21.