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NCT Number: NCT07295691

Autologous Serum Eye Drops in Dry Eye Syndrome

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.

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Key information

Conditions

Autologous Serum Eye Drops Dry Eye Syndrome Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The General Authority for Teaching Hospitals and Institutes

Cairo, 11562, Egypt

Location status: Recruiting

Location contact

Hossam A Hassan, MD

CONTACT

[email protected]

00201026808348

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Visual acuity

    Time frame: 12 weeks post-procedure

    Visual acuity will be measured.

Secondary outcomes

  1. Improvement in Ocular Surface Disease Index (OSDI)

    Time frame: 12 weeks post-procedure

    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.

  2. Incidence of adverse events

    Time frame: 12 weeks post-procedure

    Incidence of adverse events will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Hossam A Hassan, MD

CONTACT

[email protected]

00201026808348

Sponsors and collaborators

Lead sponsor

The General Authority for Teaching Hospitals and Institutes

Network

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 22, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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