Clinical Trial To Determine The Effectiveness And Safety Of Topical Insulin In Dry Eye

Dry Eye Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05692739
• Other study ID #: 22/211-EC_M
• Status: Recruiting
• Phase: Phase 4
• Start date: October 5, 2022
• Est. completion date: October 2024

Study information

• Verified date: February 2024
• Source: Hospital San Carlos, Madrid
• Contact: Barbara Burgos Blasco, MD, PhD
• Phone: +34 913303000
• Email: barbara.burgos[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Insulin
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Insulin
see arm description
• Cyclosporins
see arm description
• Artificial tears
see arm description

Locations

Country	Name	City	State
Spain	Hospital Clinico San Carlos	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Barbara Burgos Blasco

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of corneal staining from baseline to 6 months after treatment	Corneal staining will be evaluated on the slit-lamp and on slit-lamp images (masked evaluator)	From baseline to 6 months after treatment
Secondary	Changes in dry eye symptoms from baseline to 6 months after treatment time	Dry eye symptoms will be evaluated using OSDI	From baseline to 6 months after treatment
Secondary	Changes in esthesiometry from baseline to 6 months after treatment time	Esthesiometry will be evaluated using an esthesiometer	From baseline to 6 months after treatment
Secondary	Changes in tear rupture time from baseline to 6 months after treatment time	Tear rupture time will be evaluated using the Keratograph (Oculus)	From baseline to 6 months after treatment