NCT07469865Completed
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
Source: ClinicalTrials.gov · Last updated 13 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 46 (actual)
- First submitted
- 9 Mar 2026
- Start date
- 30 Nov 2021
- Primary completion date
- 14 Nov 2024
- Lead sponsor
- University Hospital, Ghent
- NCT number
- NCT07469865
What you commit to
- Study type: Interventional
- Participants enrolled: 46
- From 30 Nov 2021 to the primary completion date, 14 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- History of non-compliance with the proposed therapy D. Presence of known severe anemia based on medical history E. Hypersensitivity to the proposed treatment F. Pregnancy G. Age \<18 years H. In the opinion of the investigator, the subject is not suitable for participation in the study
Other
- The exclusion criteria for patients participating in this study are defined as follows:
- Inability to complete the study protocol, including study-specific procedures.
- Inability to understand the Dutch-language ICF and/or unwillingness or inability to provide signed informed consent.
Who the study is looking for
- The inclusion criteria for patients participating in this study are defined as follows: patients with severe Dry Eye Disease, including severe symptoms as evaluated with a standardized instrument (OSDI score \> 33), associated with at least one of the following objective parameters:
- Tear break-up time (tBUT) as a measure of tear film quality \< 5 seconds B. Positive corneal and conjunctival staining quantified according to the SICCA OSS scale C. Schirmer 1 test score \< 5 mm/5 min (without anesthesia)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ghent university hospital Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.