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Dry Eye DiseaseASTNCT07469865

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

A study testing Preservative-free artificial tears, Autologous serum eyedrops 20% and Autologous serum eyedrops 100% in people with Dry Eye Disease, run by University Hospital, Ghent at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dry Eye Disease
What is being tested?
Preservative-free artificial tears, Autologous serum eyedrops 20% and Autologous serum eyedrops 100%
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteBelgium
Study dates
30 Nov 2021to 30 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.
  • 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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Ghent University Hospital

    Ghent, Oost-Vlaanderen, 9000

Other trials in Belgium

About this study

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

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.

Read the 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
Being tested
Preservative-free artificial tears, Autologous serum eyedrops 20%, Autologous serum eyedrops 100%
Keywords
Dry eye disease, Autologous Serum, Artificial Tears, Tear Cytokines, Graft-versus-Host Disease, Sjögren's Syndrome, Systemic Sclerosis
Medical subject headings
Dry Eye Syndromes, Graft vs Host Disease, Sjogren's Syndrome, Scleroderma, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Preservative-free artificial tearsDrug

    Also called PFAT

    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.

  • Autologous serum eyedrops 20%Drug

    Also called ASED 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.

  • Autologous serum eyedrops 100%Drug

    Also called ASED 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.

Study groups in NCT07469865
Study groupRoleWhat they receive
Sequence 1: T1-T2-T3ExperimentalAfter 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.
Receives: Drug: Preservative-free artificial tears; Drug: Autologous serum eyedrops 20%; Drug: Autologous serum eyedrops 100%
Sequence 2: T1-T3-T2ExperimentalAfter 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.
Receives: Drug: Preservative-free artificial tears; Drug: Autologous serum eyedrops 20%; Drug: Autologous serum eyedrops 100%
Sequence 3: T2-T3-T1ExperimentalAfter 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.
Receives: Drug: Preservative-free artificial tears; Drug: Autologous serum eyedrops 20%; Drug: Autologous serum eyedrops 100%
Sequence 4: T2-T1-T3ExperimentalAfter 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.
Receives: Drug: Preservative-free artificial tears; Drug: Autologous serum eyedrops 20%; Drug: Autologous serum eyedrops 100%
Sequence 5: T3-T1-T2ExperimentalAfter 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.
Receives: Drug: Preservative-free artificial tears; Drug: Autologous serum eyedrops 20%; Drug: Autologous serum eyedrops 100%
Sequence 6: T3-T2-T1ExperimentalAfter 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.
Receives: Drug: Preservative-free artificial tears; Drug: Autologous serum eyedrops 20%; Drug: Autologous serum eyedrops 100%

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 8 weeks

Secondary outcomes (7)

  1. 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)

    SICCA OSS

    Measured: 8 weeks

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

    Schirmer 1 test

    Measured: 8 weeks

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

    BCVA

    Measured: 8 weeks

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

    tBUT

    Measured: 8 weeks

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

    NiBUT

    Measured: 8 weeks

  6. Change from baseline in conjunctival injection score (CIS)

    CIS

    Measured: 8 weeks

  7. Change from baseline in Meibomian Gland Dysfunction (MGD) grade

    MGD

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2026
  2. Study start30 Nov 2021
  3. Primary completion14 Nov 2024
  4. Study completion30 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
Double blind
Who is masked
Care provider, Investigator
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07469865
Sponsor's protocol ID
BC-10591
Other IDs
B6702021001102
Acronym
AST
Status last verified
Mar 2026
First submitted
9 Mar 2026
Last updated
13 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 15733983

  • 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.

    PubMed 22670856

  • 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.

    PubMed 24566903

  • 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.

    PubMed 11685055

  • 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.

    PubMed 15090417

  • 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.

    PubMed 39808128

Questions about this trial

What is this clinical trial studying?

A study testing Preservative-free artificial tears, Autologous serum eyedrops 20% and Autologous serum eyedrops 100% in people with Dry Eye Disease, run by University Hospital, Ghent at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07469865, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.

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