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ACTIVE NOT RECRUITING
NCT06931041
PHASE3

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

Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2024-02-01

Completion Date

2025-06-01

Last Updated

2025-04-16

Healthy Volunteers

No

Interventions

DRUG

insulin lispro

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

OTHER

Autologous serum

Autologous Serum

Locations (1)

Instituto de Oftalmologia Conde de Valenciana IAP

Mexico City, Mexico