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

NCT06931041 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: CEI-2023/10/04
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dry Eye; Sjogren Syndrome

Keywords

Dry eye; Sjogren Syndrome; Insulin; Autologous Serum

Outcome Measures

Primary Outcomes (1)

• OSDI

  Ocular Surface Disease Index

  From enrollment, 10 days and 30 days after starting treatment.

Secondary Outcomes (4)

• Ocular surface staining (Van-Bijsterveld score)

  From enrollment, 10 days and 30 days after starting treatment.

• Schirmer test

  From enrollment, 10 days and 30 days after starting treatment.

• non-invasive tear break-up time (NITBUT)

  From enrollment, 10 days and 30 days after starting treatment.

• Tear meniscus height (TMH)

  From enrollment, 10 days and 30 days after starting treatment.

Study Arms (2)

Insulin

ACTIVE COMPARATOR

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

Drug: insulin lispro; Other: Autologous serum

Sham

SHAM COMPARATOR

Autologous Serum without insulin.

Other: Autologous serum

Interventions

insulin lispro DRUG

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

Insulin

Autologous serum OTHER

Autologous Serum

Insulin; Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Instituto de Oftalmología Fundación Conde de Valenciana: lead

Study Sites (1)

Instituto de Oftalmologia Conde de Valenciana IAP

Mexico City, 06800, Mexico

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Sjogren's Syndrome; Insulin Resistance

Interventions

Insulin Lispro

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized, single-blinded clinical trial will include patients aged 18 years and older who are diagnosed with moderate to severe DED associated with primary (PSS) or secondary (SSS) Sjögren's Syndrome. Both groups will receive ASED at a concentration of 30%. In group 2, 1 UI/ml of insulin will be added to the ASED formulation. The dosage will consist of one drop every 6 hours for 30 days in both groups. The following parameters will be evaluated at baseline (day 0), day 10, and day 30 of treatment: best corrected visual acuity (BCVA), ocular surface staining (Van-Bijsterveld score), Schirmer test, non-invasive tear break-up time (NITBUT), tear meniscus height (TMH), bulbar conjunctival hyperemia (BCH), and Ocular Surface Disease Index (OSDI) score. Statistical analysis will be performed using ANOVA for time/group comparisons with STATA 18.0 software.

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 16, 2025
• Study Start: February 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Locations

ME (1)