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Completed

NCT Number: NCT05692739

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clinico San Carlos

Madrid, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Insulin

Drug

see arm description

cyclosporins

Drug

see arm description

Artificial Tears

Drug

see arm description

Primary outcomes

  1. Change of corneal staining from baseline to 6 months after treatment

    Time frame: From baseline to 6 months after treatment

    Corneal staining will be evaluated on the slit-lamp and on slit-lamp images (masked evaluator)

Secondary outcomes

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

    Time frame: From baseline to 6 months after treatment

    Dry eye symptoms will be evaluated using OSDI

  2. Changes in esthesiometry from baseline to 6 months after treatment time

    Time frame: From baseline to 6 months after treatment

    Esthesiometry will be evaluated using an esthesiometer

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

    Time frame: From baseline to 6 months after treatment

    Tear rupture time will be evaluated using the Keratograph (Oculus)

Sponsors and collaborators

Lead sponsor

Barbara Burgos Blasco

Other

Registry information

Official study title

Ensayo Clínico Para Determinar La Eficacia Y Seguridad Del Colirio De Insulina En El Tratamiento Del Ojo Seco En Pacientes Con Ojo Seco

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 20, 2023
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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