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Could insulin eye drops ease dry eye? new trial results

NCT ID NCT05692739

Symptom relief Sponsor: Barbara Burgos Blasco Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested if insulin eye drops can safely and effectively treat moderate to severe dry eye disease. 116 adults received either insulin drops, standard cyclosporin drops, or artificial tears (placebo) for 6 months. The main goal was to see if insulin drops improved corneal surface damage and dry eye symptoms better than existing treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

116 people

The number who actually took part.

Started

Oct 2022

Finished

Nov 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

dry eye syndrome Insulin Resistance

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dry eye Insulin

Contacts and locations

Locations

  • Hospital Clinico San Carlos

    Madrid, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.