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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05692739
Other study ID # 22/211-EC_M
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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)

Study Design


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
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