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

Instituto de Oftalmología Fundación Conde de Valenciana

Status and phase: Active, not recruiting; Phase 3

Conditions: Sjogren Syndrome; Dry Eye

Treatments: Other: Autologous serum; Drug: insulin lispro

Study type: Interventional

Funder types: Other

Identifiers

NCT06931041

CEI-2023/10/04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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25 participants in 2 patient groups

Insulin

Active Comparator group

Description:

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

Treatment:

Drug: insulin lispro

Other: Autologous serum

Sham

Sham Comparator group

Description:

Autologous Serum without insulin.

Treatment:

Other: Autologous serum