Clinical Trial to Determine the Effectiveness and Safety of Topical Insulin in Dry Eye

Last updated: October 18, 2024
Sponsor: Barbara Burgos Blasco
Overall Status: Active - Recruiting

Phase

4

Condition

Dry Eyes

Sjogren's Syndrome

Dry Eye Disease

Treatment

Cyclosporins

Insulin

Artificial tears

Clinical Study ID

NCT05692739
22/211-EC_M
  • Ages > 18
  • All Genders

Study 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

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

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 drainageabnormalities, 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 thatdoes not allow the examination (such as mental or psychomotor retardation)

Study Design

Total Participants: 120
Treatment Group(s): 3
Primary Treatment: Cyclosporins
Phase: 4
Study Start date:
October 19, 2022
Estimated Completion Date:
September 30, 2025

Study 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.

Connect with a study center

  • Hospital Clinico San Carlos

    Madrid,
    Spain

    Active - Recruiting

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