NCT07469865

Efficacy and Safety of 20% and 100% Autologous Serum Eye Drops in Patients With Severe Dry Eye Disease (AST)

Efficacy and Safety of 20% and 100% Autologous Serum Eye Drops in Patients With Severe Dry Eye Disease: a Prospective, Blinded, Randomized, Crossover Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective, single-blinded, randomized, controlled crossover trial was conducted in patients with severe dry eye syndrome. Topical treatment with autologous serum eye drops (ASED) diluted at 20%, undiluted ASED and conventional preservative-free artificial tears (PFAT) were compared as a treatment for severe dry eye disease. The primary outcome measure was assessment of ocular symptoms using the Ocular Surface Disease Index (OSDI) questionnaire. Secondary outcomes were Schirmer 1 test, best-corrected visual acuity (BVCA), corneal fluorescein and conjunctival lissamine green staining using the Sjögren's International Collaborative Clinical Alliance Ocular Surface Staining (SICCA OSS) score, tear break up time (TBUT), conjunctival injection score (CIS) and Meibomian gland dysfunction (MGD) grading. Additionally, serum and tear cytokine analysis and microbiological cultures were performed.

Detailed description

This prospective, single-blinded, randomized, crossover clinical trial analyzed the difference in subjective symptoms and clinical signs between 20% and 100% autologous serum eye drops (ASED) versus preservative-free artificial tears (PFAT). After signing the informed consent form, each patient was randomized via RedCap. A 2-week washout was initiated prior to the baseline visit and the start of the first treatment. Patients were asked to discontinue current PFAT and/or ASED and replace them with the washout, in the form of preservative-free 3% trehalose and 0.15% hyaluronic acid (HA)-containing artificial tears. Concurrent use of necessary ocular anti-inflammatory therapy (cyclosporine, hydrocortisone) and moisturizing ocular ointment at night was allowed, provided it was maintained throughout the entire crossover study. Each patient received three 8-week treatments in a randomized sequence, being PFAT, AS 20% and AS 100%. After 8 weeks of treatment, the treatment effect was evaluated during a scheduled study visit. The patient was then instructed to start a new washout of 2 weeks to immediately follow with the next treatment. The same preservative-free artificial tears containing 3% trehalose and 0.15% hyaluronic acid (HA) were used during the PFAT treatment as during the washout. The total study duration was 30 weeks (Figure 1). The examining ophthalmologist (DR) was blinded to the type of eyedrops given to each patient in the trial. The minimum dosage for the eye drops (AS and PFAT) was eight times a day. If necessary, hourly application was allowed. In that case, the patient was asked to continue hourly application for all three treatments.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	Preservative-free artificial tears	Each patient received three 8-week treatments in a randomized sequence, being PFAT, AS 20% and AS 100%. After 8 weeks of treatment, the treatment effect was evaluated during a scheduled study visit. The patient was then instructed to start a new washout of 2 weeks to immediately follow with the next treatment.
DRUG	Autologous serum eyedrops 20%	Each patient received three 8-week treatments in a randomized sequence, being PFAT, AS 20% and AS 100%. After 8 weeks of treatment, the treatment effect was evaluated during a scheduled study visit. The patient was then instructed to start a new washout of 2 weeks to immediately follow with the next treatment.
DRUG	Autologous serum eyedrops 100%	Each patient received three 8-week treatments in a randomized sequence, being PFAT, AS 20% and AS 100%. After 8 weeks of treatment, the treatment effect was evaluated during a scheduled study visit. The patient was then instructed to start a new washout of 2 weeks to immediately follow with the next treatment.

Timeline

• Start date: 2021-11-30
• Primary completion: 2024-11-14
• Completion: 2025-12-30
• First posted: 2026-03-13
• Last updated: 2026-03-13

Locations

1 site across 1 country: Belgium