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

March 9, 2026 updated by: University Hospital, Ghent

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Ghent University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sequence 1: T1-T2-T3
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
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.
Other Names:
  • PFAT
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.
Other Names:
  • ASED 20%
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.
Other Names:
  • ASED 100%
Experimental: Sequence 2: T1-T3-T2
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
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.
Other Names:
  • PFAT
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.
Other Names:
  • ASED 20%
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.
Other Names:
  • ASED 100%
Experimental: Sequence 3: T2-T3-T1
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
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.
Other Names:
  • PFAT
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.
Other Names:
  • ASED 20%
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.
Other Names:
  • ASED 100%
Experimental: Sequence 4: T2-T1-T3
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
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.
Other Names:
  • PFAT
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.
Other Names:
  • ASED 20%
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.
Other Names:
  • ASED 100%
Experimental: Sequence 5: T3-T1-T2
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
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.
Other Names:
  • PFAT
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.
Other Names:
  • ASED 20%
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.
Other Names:
  • ASED 100%
Experimental: Sequence 6: T3-T2-T1
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
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.
Other Names:
  • PFAT
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.
Other Names:
  • ASED 20%
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.
Other Names:
  • ASED 100%

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
OSDI
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 8 weeks
SICCA OSS
8 weeks
Change from baseline in Schirmer 1 tear production test (mm)
Time Frame: 8 weeks
Schirmer 1 test
8 weeks
Change from baseline in best-corrected visual acuity (BCVA, Snellen)
Time Frame: 8 weeks
BCVA
8 weeks
Change from baseline in tear film break-up time at the slit lamp (tBUT, sec)
Time Frame: 8 weeks
tBUT
8 weeks
Change from baseline in non-invasive break-up-time (NiBUT) using anterior segment ocular coherence tomography (OCT) (sec)
Time Frame: 8 weeks
NiBUT
8 weeks
Change from baseline in conjunctival injection score (CIS)
Time Frame: 8 weeks
CIS
8 weeks
Change from baseline in Meibomian Gland Dysfunction (MGD) grade
Time Frame: 8 weeks
MGD
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Ghent

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dimitri Roels, MD, Department of Ophthalmology, Ghent University Hospital Belgium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 14, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BC-10591
  • B6702021001102 (Registry Identifier: Belgian Unique Notification Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dry Eye Disease

Clinical Trials on Preservative-free artificial tears

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings