CClinicalTrials.gg
Sign In
CompletedNCT06931041Updated Aug 27, 2026

Comparing Efficacy of Autologous Serum Eye Drops With and Without Insulin in Autoimmune Dry Eye.

A Phase 3 interventional study of recombinant human insulin and Autologous serum in Dry Eye and Sjogren Syndrome, sponsored by Instituto de Oftalmología Fundación Conde de Valenciana. Completed at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Instituto de Oftalmología Fundación Conde de Valenciana · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Feb 2024, registered Apr 2025).
Phase
Phase 3
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Introduction:

Dry Eye Disease (DED) of autoimmune origin is often severe and resistant to conventional treatments, necessitating alternative therapeutic options. Autologous Serum Eye Drops (ASED) have gained recognition for their biochemical and biomechanical properties, which closely mimic those of human tears. These properties make ASED an effective treatment for DED. Furthermore, topical insulin has demonstrated anti-inflammatory effects and promotes epithelial cell proliferation, differentiation, and migration, all of which contribute to maintaining ocular surface stability. As a result, insulin may serve as a valuable adjunct in treating moderate to severe autoimmune DED.

Purpose:

This study aims to assess and compare the effectiveness of autologous serum eye drops (group 1) and autologous serum eye drops combined with insulin (group 2) in improving the clinical signs and symptoms of moderate to severe DED in patients with autoimmune diseases, particularly those with Sjögren's Syndrome.

Read the detailed description

Introduction:

Dry Eye Disease (DED) of autoimmune origin is often severe and resistant to conventional treatments, necessitating alternative therapeutic options. Autologous Serum Eye Drops (ASED) have gained recognition for their biochemical and biomechanical properties, which closely mimic those of human tears. These properties make ASED an effective treatment for DED. Furthermore, topical insulin has demonstrated anti-inflammatory effects and promotes epithelial cell proliferation, differentiation, and migration, all of which contribute to maintaining ocular surface stability. As a result, insulin may serve as a valuable adjunct in treating moderate to severe autoimmune DED.

Purpose:

This study aims to assess and compare the effectiveness of autologous serum eye drops (group 1) and autologous serum eye drops combined with insulin (group 2) in improving the clinical signs and symptoms of moderate to severe DED in patients with autoimmune diseases, particularly those with Sjögren's Syndrome.

02

Conditions studied

  • Dry Eye
  • Sjogren Syndrome

Keywords

  • Dry eye
  • Sjogren Syndrome
  • Insulin
  • Autologous Serum
03

In context

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.

This study's enrollment of 25 is below the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Instituto de Oftalmología Fundación Conde de Valenciana is the lead sponsor of 45 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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:

  • 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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
25 participants (actual)

Study arms

  • Active comparator
    Insulin

    1 UI/ml of insulin added to the autologous serum formulation.

    Drug: recombinant human insulin · Other: Autologous serum

  • Sham comparator
    Sham

    Autologous Serum without insulin.

    Other: Autologous serum

Interventions

  • Drugrecombinant human insulin

    1 UI/ml of insulin added to the autologous serum formulation.

  • OtherAutologous serum

    Autologous Serum

06

What researchers measure

Primary outcomes

  1. OSDI

    Ocular Surface Disease Index

    Time frame: From enrollment, 10 days and 30 days after starting treatment.

Secondary outcomes

  1. Ocular surface staining (Van-Bijsterveld score)

    Time frame: From enrollment, 10 days and 30 days after starting treatment.

  2. Schirmer test

    Time frame: From enrollment, 10 days and 30 days after starting treatment.

  3. non-invasive tear break-up time (NITBUT)

    Time frame: From enrollment, 10 days and 30 days after starting treatment.

  4. Tear meniscus height (TMH)

    Time frame: From enrollment, 10 days and 30 days after starting treatment.

07

Study locations

1 site
  • Instituto de Oftalmologia Conde de Valenciana IAP
    Mexico City, Mexico City 06800, Mexico
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06931041
Lead sponsor
Instituto de Oftalmología Fundación Conde de Valenciana
Responsible party
Sponsor
First posted
Apr 16, 2025
Start date
Feb 1, 2024
Primary completion
Jun 1, 2025
Completion
Jun 1, 2025
Last update
Aug 27, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Dry Eye Syndromes→

Other studies from this sponsor

Instituto de Oftalmología Fundación Conde de Valenciana

Start the discussion