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Insulin-spiked eye drops may ease stubborn dry eye in Sjögren's patients

NCT ID NCT06931041

Disease control Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This trial tests whether adding insulin to autologous serum eye drops (made from a patient's own blood) improves symptoms and signs of moderate to severe dry eye in people with autoimmune conditions like Sjögren's syndrome. Researchers will compare standard serum drops against serum drops with insulin in 25 adults. They will measure eye surface damage, tear production, and patient-reported comfort to see if insulin adds any benefit.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Autologous serum eye drops with or without added recombinant human insulin
What this could lead to
If adding insulin to autologous serum eye drops works, it could offer a more effective treatment for severe autoimmune dry eye, especially in Sjögren's syndrome.
What could go wrong
The trial is small (25 participants) and early, so results may not apply broadly. Adding insulin could cause irritation or other side effects, and the benefit over standard serum drops is unproven.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

25 people

The number who actually took part.

Started

Feb 2024

Finished

Jun 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: * Inclusion criteria included men and women aged 18 years or older with a diagnosis of primary\[ and secondary SS confirmed by a rheumatologist using the 2016 ACR-EULAR diagnostic criteria, and moderate to severe DED. Moderate to severe DED was classified using the following standardized parameters: Ocular Surface Disease Index (OSDI) ≥ 23 points, ocular surface staining according to the Van Bijsterveld score ≥ 4 points, non-invasive tear break-up time (NITBUT) ≤ 7 seconds, and tear meniscus height (TMH) ≤ 0.3 mm, measured with the Keratograph 5M (Oculus, Wetzlar, Germany). Participants were required to be willing to comply with the study protocol and follow-up schedule. Exclusion Criteria: * Exclusion criteria included participation in another clinical trial in the preceding three weeks, topical use of aminoglycoside antibiotics, therapeutic contact lens use, known hypersensitivity to any component of the study medications, active ocular infection, ocular surgery or trauma within three months, or any abnormality compromising corneal integrity. Additionally, patients with a history of corneal transplantation, pregnancy or lactation, or planned pregnancy were excluded.

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Conditions

The condition(s) this trial relates to.

dry eye syndrome Insulin Resistance Sjogren syndrome

As listed by the trial registrant

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

Dry eye Sjogren syndrome

Contacts and locations

Locations

  • Instituto de Oftalmologia Conde de Valenciana IAP

    Mexico City, Mexico City, 06800, Mexico

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