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

NCT05692739 | Completed Phase 4

• 1 other identifier: 22/211-EC_M
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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).

Conditions

Dry Eye; Insulin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Changes in dry eye symptoms from baseline to 6 months after treatment time

  From baseline to 6 months after treatment

• Changes in esthesiometry from baseline to 6 months after treatment time

  From baseline to 6 months after treatment

• Changes in tear rupture time from baseline to 6 months after treatment time

  From baseline to 6 months after treatment

Study Arms (3)

Insulin

EXPERIMENTAL

Topical insulin 1UI/ml 4 times a day

Drug: Insulin

Cyclosporin

ACTIVE COMPARATOR

Cyclosporin 0,05% every 12 hours

Drug: Cyclosporins

Artificial tears

PLACEBO COMPARATOR

Artificial tears 4 times a day

Drug: Artificial tears

Interventions

Insulin DRUG

see arm description

Insulin

Cyclosporins DRUG

see arm description

Cyclosporin

Artificial tears DRUG

see arm description

Artificial tears

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Barbara Burgos Blasco: lead

Study Sites (1)

Hospital Clinico San Carlos

Madrid, Spain

Location

Related Publications (2)

• 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.

  PMID: 34407296 BACKGROUND

• 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.

  PMID: 32951459 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes; Insulin Resistance

Interventions

Insulin; Cyclosporins; Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Study Officials

• Barbara Burgos Blasco, MD, PhD

  Hospital Clinico San Carlos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ophthalmologist

Model Details: 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)

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 20, 2023
• Study Start: October 19, 2022
• Primary Completion: November 5, 2025
• Study Completion: November 5, 2025
• Last Updated: March 5, 2026

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)