Comparing Efficacy of Autologous Serum Eye Drops With and Without Insulin in Autoimmune Dry Eye: A Randomized Clinical Trial

Last updated: April 9, 2025
Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana
Overall Status: Active - Not Recruiting

Phase

3

Condition

Dermatomyositis (Connective Tissue Disease)

Dry Eye Disease

Lupus

Treatment

insulin lispro

Autologous serum

Clinical Study ID

NCT06931041
CEI-2023/10/04
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Inclusion criteria included men and women aged 18 years or older with a diagnosis ofprimary[ and secondary SS confirmed by a rheumatologist using the 2016 ACR-EULARdiagnostic criteria, and moderate to severe DED. Moderate to severe DED wasclassified 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 meniscusheight (TMH) ≤ 0.3 mm, measured with the Keratograph 5M (Oculus, Wetzlar, Germany).Participants were required to be willing to comply with the study protocol andfollow-up schedule.

Exclusion

Exclusion Criteria:

  • Exclusion criteria included participation in another clinical trial in the precedingthree weeks, topical use of aminoglycoside antibiotics, therapeutic contact lensuse, known hypersensitivity to any component of the study medications, active ocularinfection, ocular surgery or trauma within three months, or any abnormalitycompromising corneal integrity. Additionally, patients with a history of cornealtransplantation, pregnancy or lactation, or planned pregnancy were excluded.

Study Design

Total Participants: 25
Treatment Group(s): 2
Primary Treatment: insulin lispro
Phase: 3
Study Start date:
February 01, 2024
Estimated Completion Date:
June 01, 2025

Study 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.

Connect with a study center

  • Instituto de Oftalmologia Conde de Valenciana IAP

    Mexico City, 06800
    Mexico

    Site Not Available

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