Autologous Serum Eye Drops in Dry Eye Syndrome

NCT07295691 | Recruiting

• 1 other identifier: HSO00010
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autologous Serum Eye Drops; Dry Eye Syndrome

Outcome Measures

Primary Outcomes (1)

• Visual acuity

  Visual acuity will be measured.

  12 weeks post-procedure

Secondary Outcomes (2)

• Improvement in Ocular Surface Disease Index (OSDI)

  12 weeks post-procedure

• Incidence of adverse events

  12 weeks post-procedure

Study Arms (1)

Study group

EXPERIMENTAL

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

Interventions

Autologous Serum Eye Drop OTHER

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.

Study group

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The General Authority for Teaching Hospitals and Institutes: lead

Study Sites (1)

The General Authority for Teaching Hospitals and Institutes

Cairo, 11562, Egypt

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Central Study Contacts

Hossam A Hassan, MD

CONTACT

00201026808348; Dr.hossameabdalfataah@gothi.gov.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow of Ophthalmology, Sohag Teaching Hospital, Egypt.

Study Record Dates

• First Submitted: December 6, 2025
• First Posted: December 22, 2025
• Study Start: September 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)