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

NCT07469865 | Completed

• 2 other identifiers: BC-10591B6702021001102
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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

Dry Eye Disease

Keywords

Dry eye disease; Autologous Serum; Artificial Tears; Tear Cytokines; Graft-versus-Host Disease; Sjögren's Syndrome; Systemic Sclerosis

Outcome Measures

Primary Outcomes (1)

• Change from baseline in participant-reported severity and/or frequency of dry eye-related symptoms based on a validated patient symptom questionnaire (Ocular Surface Disease Index questionnaire, OSDI)

  OSDI

  8 weeks

Secondary Outcomes (7)

• Change from baseline in ocular staining with fluorescein and lissamine green according to the Sjögren's International Collaborative Clinical Alliance Ocular Staining Score (SICCA OSS)

  8 weeks

• Change from baseline in Schirmer 1 tear production test (mm)

  8 weeks

• Change from baseline in best-corrected visual acuity (BCVA, Snellen)

  8 weeks

• Change from baseline in tear film break-up time at the slit lamp (tBUT, sec)

  8 weeks

• Change from baseline in non-invasive break-up-time (NiBUT) using anterior segment ocular coherence tomography (OCT) (sec)

  8 weeks

Study Arms (6)

Sequence 1: T1-T2-T3

EXPERIMENTAL

After a washout of 2 weeks, study participants in this arm first received 8 weeks of preservative-free artificial tears (PFAT) (T1). After 8 weeks of treatment, the first treatment effect was evaluated during a scheduled study visit. Patients were then instructed to start a new washout of 2 weeks to immediately follow with the next treatment. The second treatment is this arm was autologous serum eye drops (ASED) at a concentration of 20% (T2). After 8 weeks of treatment, the second treatment effect was evaluated during a scheduled study visit. Patients were then instructed to start a new washout of 2 weeks to immediately follow with the next treatment. The third treatment is this arm was autologous serum eye drops (ASED) at a concentration of 100% (T3). After 8 weeks of treatment, the third treatment effect was evaluated during a scheduled study visit.

Drug: Preservative-free artificial tears; Drug: Autologous serum eyedrops 20%; Drug: Autologous serum eyedrops 100%

Sequence 2: T1-T3-T2

EXPERIMENTAL

After a washout of 2 weeks, study participants in this arm first received 8 weeks of preservative-free artificial tears (PFAT) (T1). After 8 weeks of treatment, the first treatment effect was evaluated during a scheduled study visit. Patients were then instructed to start a new washout of 2 weeks to immediately follow with the next treatment. The second treatment is this arm was autologous serum eye drops (ASED) at a concentration of 100% (T3). After 8 weeks of treatment, the second treatment effect was evaluated during a scheduled study visit. Patients were then instructed to start a new washout of 2 weeks to immediately follow with the next treatment. The third treatment is this arm was autologous serum eye drops (ASED) at a concentration of 20% (T2). After 8 weeks of treatment, the third treatment effect was evaluated during a scheduled study visit.

Drug: Preservative-free artificial tears; Drug: Autologous serum eyedrops 20%; Drug: Autologous serum eyedrops 100%

Sequence 3: T2-T3-T1

EXPERIMENTAL

After a washout of 2 weeks, study participants in this arm first received 8 weeks of autologous serum eye drops (ASED) at a concentration of 20% (T2). After 8 weeks of treatment, the first treatment effect was evaluated during a scheduled study visit. Patients were then instructed to start a new washout of 2 weeks to immediately follow with the next treatment. The second treatment is this arm was autologous serum eye drops (ASED) at a concentration of 100% (T3). After 8 weeks of treatment, the second treatment effect was evaluated during a scheduled study visit. Patients were then instructed to start a new washout of 2 weeks to immediately follow with the next treatment. The third treatment is this arm was preservative-free artificial tears (PFAT) (T1). After 8 weeks of treatment, the third treatment effect was evaluated during a scheduled study visit.

Drug: Preservative-free artificial tears; Drug: Autologous serum eyedrops 20%; Drug: Autologous serum eyedrops 100%

Sequence 4: T2-T1-T3

EXPERIMENTAL

After a washout of 2 weeks, study participants in this arm first received 8 weeks of autologous serum eye drops (ASED) at a concentration of 20% (T2). After 8 weeks of treatment, the first treatment effect was evaluated during a scheduled study visit. Patients were then instructed to start a new washout of 2 weeks to immediately follow with the next treatment. The second treatment is this arm was preservative-free artificial tears (PFAT) (T1). After 8 weeks of treatment, the second treatment effect was evaluated during a scheduled study visit. Patients were then instructed to start a new washout of 2 weeks to immediately follow with the next treatment. The third treatment is this arm was autologous serum eye drops (ASED) at a concentration of 100% (T3). After 8 weeks of treatment, the third treatment effect was evaluated during a scheduled study visit.

Drug: Preservative-free artificial tears; Drug: Autologous serum eyedrops 20%; Drug: Autologous serum eyedrops 100%

Sequence 5: T3-T1-T2

EXPERIMENTAL

After a washout of 2 weeks, study participants in this arm first received 8 weeks of autologous serum eye drops (ASED) at a concentration of 100% (T3). After 8 weeks of treatment, the first treatment effect was evaluated during a scheduled study visit. Patients were then instructed to start a new washout of 2 weeks to immediately follow with the next treatment. The second treatment is this arm was preservative-free artificial tears (PFAT) (T1). After 8 weeks of treatment, the second treatment effect was evaluated during a scheduled study visit. Patients were then instructed to start a new washout of 2 weeks to immediately follow with the next treatment. The third treatment is this arm was autologous serum eye drops (ASED) at a concentration of 20% (T2). After 8 weeks of treatment, the third treatment effect was evaluated during a scheduled study visit.

Drug: Preservative-free artificial tears; Drug: Autologous serum eyedrops 20%; Drug: Autologous serum eyedrops 100%

Sequence 6: T3-T2-T1

EXPERIMENTAL

After a washout of 2 weeks, study participants in this arm first received 8 weeks of autologous serum eye drops (ASED) at a concentration of 100% (T3). After 8 weeks of treatment, the first treatment effect was evaluated during a scheduled study visit. Patients were then instructed to start a new washout of 2 weeks to immediately follow with the next treatment. The second treatment is this arm was autologous serum eye drops (ASED) at a concentration of 20% (T2). After 8 weeks of treatment, the second treatment effect was evaluated during a scheduled study visit. Patients were then instructed to start a new washout of 2 weeks to immediately follow with the next treatment. The third treatment is this arm was preservative-free artificial tears (PFAT) (T1). After 8 weeks of treatment, the third treatment effect was evaluated during a scheduled study visit.

Drug: Preservative-free artificial tears; Drug: Autologous serum eyedrops 20%; Drug: Autologous serum eyedrops 100%

Interventions

Preservative-free artificial tears DRUG

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.

Also known as: PFAT

Sequence 1: T1-T2-T3; Sequence 2: T1-T3-T2; Sequence 3: T2-T3-T1; Sequence 4: T2-T1-T3; Sequence 5: T3-T1-T2; Sequence 6: T3-T2-T1

Autologous serum eyedrops 20% DRUG

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.

Also known as: ASED 20%

Sequence 1: T1-T2-T3; Sequence 2: T1-T3-T2; Sequence 3: T2-T3-T1; Sequence 4: T2-T1-T3; Sequence 5: T3-T1-T2; Sequence 6: T3-T2-T1

Autologous serum eyedrops 100% DRUG

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.

Also known as: ASED 100%

Sequence 1: T1-T2-T3; Sequence 2: T1-T3-T2; Sequence 3: T2-T3-T1; Sequence 4: T2-T1-T3; Sequence 5: T3-T1-T2; Sequence 6: T3-T2-T1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Related Publications (6)

• Kojima T, Ishida R, Dogru M, Goto E, Matsumoto Y, Kaido M, Tsubota K. The effect of autologous serum eyedrops in the treatment of severe dry eye disease: a prospective randomized case-control study. Am J Ophthalmol. 2005 Feb;139(2):242-6. doi: 10.1016/j.ajo.2004.08.040.

  PMID: 15733983 BACKGROUND

• Urzua CA, Vasquez DH, Huidobro A, Hernandez H, Alfaro J. Randomized double-blind clinical trial of autologous serum versus artificial tears in dry eye syndrome. Curr Eye Res. 2012 Aug;37(8):684-8. doi: 10.3109/02713683.2012.674609. Epub 2012 Jun 6.

  PMID: 22670856 BACKGROUND

• Celebi AR, Ulusoy C, Mirza GE. The efficacy of autologous serum eye drops for severe dry eye syndrome: a randomized double-blind crossover study. Graefes Arch Clin Exp Ophthalmol. 2014 Apr;252(4):619-26. doi: 10.1007/s00417-014-2599-1. Epub 2014 Feb 25.

  PMID: 24566903 BACKGROUND

• Tananuvat N, Daniell M, Sullivan LJ, Yi Q, McKelvie P, McCarty DJ, Taylor HR. Controlled study of the use of autologous serum in dry eye patients. Cornea. 2001 Nov;20(8):802-6. doi: 10.1097/00003226-200111000-00005.

  PMID: 11685055 BACKGROUND

• Noble BA, Loh RS, MacLennan S, Pesudovs K, Reynolds A, Bridges LR, Burr J, Stewart O, Quereshi S. Comparison of autologous serum eye drops with conventional therapy in a randomised controlled crossover trial for ocular surface disease. Br J Ophthalmol. 2004 May;88(5):647-52. doi: 10.1136/bjo.2003.026211.

  PMID: 15090417 BACKGROUND

• Bachtalia K, Plakitsi A, Voudouri A, Terzidou C, Dalianis G, Kopsinis G, Palioura S. The Effect of Autologous Serum Tears 50% on the Ocular Surface of Patients With Severe Dry Eye Disease due to Sjogren Syndrome: A Prospective, Double-Blind, Randomized, Controlled, Contralateral Eye Study. Cornea. 2025 Jan 14;44(7):856-865. doi: 10.1097/ICO.0000000000003795.

  PMID: 39808128 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes; Graft vs Host Disease; Sjogren's Syndrome; Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Immune System Diseases; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Skin Diseases

Study Officials

• Dimitri Roels, MD

  Department of Ophthalmology, Ghent University Hospital Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: The examining ophthalmologist was blinded to the type of eyedrops given to each patient in the trial. Due to differences in color and viscosity of the different eye drops, complete blinding of the study patient was deemed impossible. All data were collected in REDCap by an unblinded study coordinator. The database was locked and the blinding lifted only after the Database Lock Approval Form had been signed by the principal investigator following completion of the entire study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 13, 2026
• Study Start: November 30, 2021
• Primary Completion: November 14, 2024
• Study Completion: December 30, 2025
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)