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

April 9, 2025 updated by: Instituto de Oftalmología Fundación Conde de Valenciana

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 06800
        • Instituto de Oftalmologia Conde de Valenciana IAP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Insulin
1 UI/ml of insulin added to the autologous serum formulation.
Drug: insulin lispro
1 UI/ml of insulin added to the autologous serum formulation.
Other: Autologous serum
Autologous Serum
Sham Comparator: Sham
Autologous Serum without insulin.
Other: Autologous serum
Autologous Serum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OSDI
Time Frame: From enrollment, 10 days and 30 days after starting treatment.
Ocular Surface Disease Index
From enrollment, 10 days and 30 days after starting treatment.

Secondary Outcome Measures

Outcome Measure
Time Frame
Ocular surface staining (Van-Bijsterveld score)
Time Frame: From enrollment, 10 days and 30 days after starting treatment.
From enrollment, 10 days and 30 days after starting treatment.
Schirmer test
Time Frame: From enrollment, 10 days and 30 days after starting treatment.
From enrollment, 10 days and 30 days after starting treatment.
non-invasive tear break-up time (NITBUT)
Time Frame: From enrollment, 10 days and 30 days after starting treatment.
From enrollment, 10 days and 30 days after starting treatment.
Tear meniscus height (TMH)
Time Frame: From enrollment, 10 days and 30 days after starting treatment.
From enrollment, 10 days and 30 days after starting treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Oftalmología Fundación Conde de Valenciana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

April 9, 2025

First Submitted That Met QC Criteria

April 9, 2025

First Posted (Actual)

April 16, 2025

Study Record Updates

Last Update Posted (Actual)

April 16, 2025

Last Update Submitted That Met QC Criteria

April 9, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEI-2023/10/04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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