Eye drops made from a child's own blood serum for dry eyes

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

This will try eye drops made from each child's own blood serum to see if they help children under 18 with moderate-to-severe dry eye that hasn't improved with artificial tears.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: N/A to 18 Years
• Sex: All
• Sponsor: The General Authority for Teaching Hospitals and Institutes (network)
• Locations: 1 site (Cairo)
• Trial ID: NCT07295691 on ClinicalTrials.gov

What this trial studies

This interventional study tests autologous serum eye drops (ASEDs) in children with moderate-to-severe dry eye syndrome who have not responded to conventional artificial tears. ASEDs are prepared from a patient's own blood and contain growth factors and proteins that mimic natural tears to promote epithelial healing and reduce inflammation. Participants who meet inclusion and exclusion criteria receive the autologous serum drops and are monitored for clinical signs, symptoms, and safety outcomes over a specified follow-up period. The single-site trial is conducted at The General Authority for Teaching Hospitals and Institutes in Cairo and excludes patients with active ocular infection, recent ocular surgery, systemic immunosuppression, or allergy to blood-derived products.

Who should consider this trial

Good fit: Ideal candidates are children under 18 with moderate-to-severe dry eye syndrome that is refractory to artificial tear therapy and who do not have active ocular infection or recent ocular surgery.

Not a fit: Patients with active eye infections, recent eye surgery, on systemic immunosuppressive therapy, or with known allergy to blood-derived products are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, ASEDs could reduce symptoms and promote healing of the ocular surface in children whose dry eye has not responded to standard artificial tears.

How similar studies have performed: Prior smaller studies and case series in adults and mixed-age groups have reported symptomatic and clinical improvements with autologous serum eye drops, though large randomized pediatric trials remain limited.

Eligibility criteria

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.

Where this trial is running

Cairo

• The General Authority for Teaching Hospitals and Institutes — Cairo, Egypt (RECRUITING)

Study contacts

• Study coordinator: Hossam A Hassan, MD

Conditions: Autologous Serum Eye Drops, Dry Eye Syndrome