Autologous Serum Eye Drops in Dry Eye Syndrome

Autologous Serum Eye Drops in Dry Eye Syndrome: Clinical Efficacy and Safety Evaluation

This study aims to evaluate the clinical efficacy and safety of autologous serum eye drops (ASEDs) in patients with moderate-to-severe dry eye syndrome who are refractory to conventional artificial tear therapy.

Study Overview

• Status: Recruiting
• Conditions: Dry Eye Syndrome; Autologous Serum Eye Drops
• Intervention / Treatment: Other: Autologous Serum Eye Drop

Detailed Description

Dry Eye Syndrome (DES) is a highly prevalent ocular condition that significantly affects quality of life, with global prevalence estimated at 5%-50%, depending on population and diagnostic criteria.

Autologous Serum Eye Drops (ASEDs) have emerged as a promising therapy due to their composition, which is rich in vitamin A, epidermal growth factor, fibronectin, and transforming growth factor-β. These components mimic natural tears and promote epithelial healing, reduce inflammation, and enhance tear film stability.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hossam A Hassan, MD; Phone Number: 00201026808348; Email: Dr.hossameabdalfataah@gothi.gov.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Recruiting
    • The General Authority for Teaching Hospitals and Institutes
    • Contact: Hossam A Hassan, MD; Phone Number: 00201026808348; Email: Dr.hossameabdalfataah@gothi.gov.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Children aged less than 18 years.
• Both sexes.
• Diagnosed with moderate to severe dry eye syndrome (DES) refractory to artificial tears.

Exclusion Criteria:

• Active ocular infection.
• Recent ocular surgery.
• Systemic immunosuppressive therapy.
• History of allergy to blood-derived products.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; Participants will receive eye drops prepared from their blood serum following a standardized protocol. Specifically, 40 mL of venous blood was collected from each participant at the start of the study and centrifuged at 3000 rpm for 15 min.	Other: Autologous Serum Eye Drop; Participants will receive eye drops prepared from their blood serum following a standardized protocol. Specifically, 40 mL of venous blood was collected from each participant at the start of the study and centrifuged at 3000 rpm for 15 min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity	Visual acuity will be measured.	12 weeks post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Ocular Surface Disease Index (OSDI)	The ocular surface disease index (OSDI) is a comprehensive 12-item questionnaire used to assess the frequency and severity of eye symptoms, the influence of environmental triggers, and the impact of DES on vision-related functionality. The OSDI scores range from 0 to 100, with higher scores indicating greater ocular discomfort and impairment.	12 weeks post-procedure
Incidence of adverse events	Incidence of adverse events will be recorded.	12 weeks post-procedure

Collaborators and Investigators

• Sponsor: The General Authority for Teaching Hospitals and Institutes

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 6, 2025
• First Submitted That Met QC Criteria: December 6, 2025
• First Posted (Actual): December 22, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 6, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: HSO00010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No