Autologous Serum Eye Drops in Dry Eye Syndrome

NCT ID: NCT07295691

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Autologous Serum Eye Drops Dry Eye Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Autologous Serum Eye Drop

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The General Authority for Teaching Hospitals and Institutes

NETWORK

Sponsor Role lead

Responsible Party

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Hossam Abdelfattah Husein Hassan

Fellow of Ophthalmology, Sohag Teaching Hospital, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The General Authority for Teaching Hospitals and Institutes

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Hossam A Hassan, MD

Role: CONTACT

Phone: 00201026808348

Email: [email protected]

Facility Contacts

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Hossam A Hassan, MD

Role: primary

Other Identifiers

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HSO00010

Identifier Type: -

Identifier Source: org_study_id