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

CompletedNA

Sponsor: University Hospital, Ghent

Conditions: Dry Eye Disease

Interventions: Preservative-free artificial tears, Autologous serum eyedrops 20%, Autologous serum eyedrops 100%

Countries: Belgium

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

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:

A. 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)

Exclusion Criteria:

The exclusion criteria for patients participating in this study are defined as follows:

A. Inability to complete the study protocol, including study-specific procedures.

B. Inability to understand the Dutch-language ICF and/or unwillingness or inability to provide signed informed consent.

C. 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

Locations (1)

Ghent, Oost-Vlaanderen, Belgium