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

NCT07469865 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-03-13

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Dimitri Roels, MD · Department of Ophthalmology, Ghent University Hospital Belgium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-30
Primary Completion
2024-11-14
Completion
2025-12-30

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07469865 on ClinicalTrials.gov