Dry Eye DiseasePhase 3NCT04683796
Comparison of Efficacy Between 100% Platelet-rich Plasma and 100% Serum Eye Drops in Dry Eye Disease
A Phase 3 study testing 100% Autologous platelet rich plasma and 100% Autologous serum in people with Dry Eye Disease, run by Mahidol University at 1 site in Thailand.
Trial summary
Dry eye disease (DED) is a common eye problem, affecting 5% to 50% of the world population. Although the disease is not fatal, it substantially reduces quality of life and creates a high economic burden as high as over 50 billion from a societal perspective. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- 100% Autologous platelet rich plasma and 100% Autologous serum
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteThailand
- Study dates
- 1 Feb 2021to 30 Mar 2023
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to less than 75 years.
- Have OSDI scores ≥ 23 or Oxford staining grade ≥ 2.
- Do not have following conditions:
- Uncontrolled systemic diseases, active infection, advanced cancer. Pregnant and nursing women. • Have not recently used the following medications/interventions/surgery: Anticoagulants or anti-platelets. Topical undiluted blood products within 3 months. Punctal plug or contact lenses. Ocular surgery within 6 months.
- Do not have active ocular infection/inflammation, abnormal eyelid function or severe meibomian gland dysfunction (MGD stage 4).
- Have no contraindication for blood donations:
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- Positive human immunodeficiency virus, hepatitis B or C, or syphilis. Anemia (Hb < 11 g/dL) or platelet concentration < 150,000/ml.
- Being able to stop current dry eye treatment for 48 hours before staring trial intervention
- Willing to comply with the 4-week study protocol and provide informed consent.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Ophthalmology Department, Ramathibodi Hospital
Ratchathewi, Bangkok, 10400
About this study
Official title: Comparison of Treatment Efficacy Between 100% Platelet-rich Plasma and 100% Serum Eye Drops in Moderate to Severe Dry Eye Disease: A Randomized Controlled Trial Protocol
Dry eye disease (DED) is a common eye problem, affecting 5% to 50% of the world population. Although the disease is not fatal, it substantially reduces quality of life and creates a high economic burden as high as over 50 billion from a societal perspective. Several biological tear substitutes (e.g., autologous serum (AS), autologous platelet rich plasma (APRP), and autologous platelet lysate (APL)) could effectively improve dry eyes, especially in patients with moderate to severe DED.. However, evidence on their comparative efficacy is controversial. The objective of the study is to compare the efficacy of 100% APRP with 100% AS eye drops in patients with moderate to severe DED.
Read the detailed description
The study is a single-center, double-blinded randomized, parallel, non-inferiority trial. Patients will be recruited from out-patient clinic, Department of Ophthalmology, Ramathibodi Hospital, Bangkok and will be randomized to receive either 100% APRP or 100% AS eye drops (1:1 ratio) for 4 weeks. The primary outcomes include ocular surface disease index (OSDI) and ocular surface staining evaluated using the Oxford scale. Secondary outcomes are fluorescein break-up time (FBUT), Schirmer's I test (ST I), meibomian gland parameters and adverse events.
- Conditions
- Dry Eye Disease
- Being tested
- 100% Autologous platelet rich plasma, 100% Autologous serum
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100% Autologous platelet rich plasmaDrug
Also called APRP
Patients' blood (36 ml per tube) will be collected in three 50-ml sterile centrifuge tubes containing 4 ml of 3.2% buffered citrate acid for anticoagulation. Tubes will be centrifuged at 350 g for 10 minutes at 20 C. The two upper layers of the centrifuged blood, the plasma and the superficial buffy coat, will be separated in a sterile manner under a laminar air flow hood. A 1.5 ml aliquot of both final blood products will be transferred into identical opaque eye drop bottles, labelled name, hospital number, dated and sealed.
100% Autologous serumDrug
Also called AS
Patients' blood (36 ml per tube) will be collected in three 50-ml sterile centrifuge tubes. The tubes will be left standing in an upright position for 1-2 hours to enable blood clot formation at room temperature (18-25 C). The tubes will be centrifuged at 3000 g for 30 minutes at 20 C. The supernatant serum will be aseptically transferred into a sterile syringe to enable filtration through a 0.2 µm pore size membrane filter under a laminar air flow hood. A 1.5 ml aliquot of both final blood products will be transferred into identical opaque eye drop bottles, labelled name, hospital number, dated and sealed.
| Study group | Role | What they receive |
|---|---|---|
| 100% APRP | Experimental | Patients will be instructed to apply every 2 hours (8 times/day). The currently used bottle will be required to store at 4 C for 24 hours, and the remaining bottles at -20 C in a freezer until day of use. Receives: Drug: 100% Autologous platelet rich plasma |
| 100% AS | Active comparator | Patients will be instructed to apply every 2 hours (8 times/day). The currently used bottle will be required to store at 4 C for 24 hours, and the remaining bottles at -20 C in a freezer until day of use. Receives: Drug: 100% Autologous serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular surface score index (OSDI)
The OSDI is a patient-reported outcome (PRO) questionnaire which was designed by Allergan, Inc. to assess range of ocular symptoms related to chronic dry eye disease and reflect patient's ability of function. It comprised 12 questions which are divided into 3 subscales including ocular symptoms (5 questions), vision-related function (4 questions), and environmental triggers (3 questions). Each of question is rated from 0 to 4 indicating none of the time, some of the time, half of the time, most of the time and all of the time, respectively. The average OSDI is transformed into a score ranged from 0 to 100, with a higher score indicating more severity of dry eye disease. The OSDI is classified as normal (0-12 points), mild (13-22 points), moderate (23-32 points) and severe (33-100).
Measured: 4 weeks
Ocular surface staining (OSS)
To assess total ocular surface staining, the cornea and conjunctival staining are graded by using Oxford scale guidelines (range grade 0 to 5). The higher score refers to higher severity of dry eye.
Measured: 4 weeks
Secondary outcomes (4)
Fluorescein break up time (FBUT)
The break up time (seconds) will be measured after fluorescein staining by using a stopwatch starting from the time of complete eye lid opening to the time of the first tear break up appear. The average values of 3 times of FBUT will be used. The reference value for DED diagnosis is used ranged from a cut-off time of less than 10 seconds for dry eye and less than 5 seconds for severe dry eye.
Measured: 4 weeks
Schirmer's test (ST)
The Schirmer test (ST) was performed using commercially available prepackaged sterile paper strips without anesthesia. The rounded bulb end of the strip was folded and placed in the lateral canthus away from the cornea and left in place for 5 minutes after which the wet strip length was recorded in mm. Tear deficiency is defined if ST is less than 5 mm wetting of the paper after 5 minutes.
Measured: 4 weeks
Meibum quality and expressibility.
Meibum quality is assessed by applying the pressure on each of 8 glands of the central third of the lower lid on a scale of 0 to 3 for each gland: 0, clear; 1, cloudy; 2, cloudy with debris (granular); and 3, thick, like toothpaste (total score range, 0-24). Higher score indicates the higher severity of meibomian gland dysfunction.
Expressibility is assessed on a scale of 0 to 3 in five glands in the lower or upper lid, according to the number of glands expressible: 0, all glands; 1, three to four glands; 2, one to two glands; and 3, no glands. Higher score indicates the higher severity of meibomian gland dysfunction.
Measured: 4 weeks
Number of patients with ocular adverse events
All ocular adverse events will be recorded throughout the study.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start1 Feb 2021
- Primary completion28 Feb 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly allocated to receive either 100% APRP or 100% AS (the same treatment for both eyes).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Passara Jongkhajornpong, Mahidol University
- Investigators
- Ammarin Thakkinstian, Ph.D., Study director, Department of Clinical Epidemiology and Biostatistics, Mahidol University, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683796
- Sponsor's protocol ID
- 1996
- Status last verified
- Oct 2023
- First submitted
- 20 Dec 2020
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon the specific request.
Publications
Jongkhajornpong P, Lekhanont K, Rattanasiri S, Pisitkun P, Thakkinstian A. Comparison of Corneal Epitheliotrophic Factors of Undiluted Autologous Platelet-Rich Plasma and Autologous Serum Eye Drops for Dry Eye Disease. Ophthalmol Ther. 2025 Feb;14(2):363-377. doi: 10.1007/s40123-024-01082-y. Epub 2024 Dec 20.
PubMed 39704778Jongkhajornpong P, Lekhanont K, Rattanasiri S, Numthavaj P, McKay G, Attia J, Thakkinstian A. Efficacy of 100% autologous platelet-rich plasma and 100% autologous serum in dry eye disease: a randomised controlled trial. BMJ Open Ophthalmol. 2024 Oct 8;9(1):e001857. doi: 10.1136/bmjophth-2024-001857.
PubMed 39384222Jongkhajornpong P, Numthavaj P, Anothaisintawee T, Lekhanont K, McKay G, Attia J, Thakkinstian A. Comparison of treatment efficacy between 100% platelet-rich plasma and 100% serum eye drops in moderate-to-severe dry eye disease: a randomised controlled trial protocol. BMJ Open. 2021 Jun 30;11(6):e048479. doi: 10.1136/bmjopen-2020-048479.
PubMed 34193498
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Treatment Efficacy Between 100% Platelet-rich Plasma and 100% Serum Eye Drops in Moderate to Severe Dry Eye Disease: A Randomized Controlled Trial Protocol
- ClinicalTrials.gov ID
- NCT04683796
- Acronym / sponsor ID
- 1996
- Conditions
- Dry Eye Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 24 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dry eye disease (DED) is a common eye problem, affecting 5% to 50% of the world population. Although the disease is not fatal, it substantially reduces quality of life and creates a high economic burden as high as over 50 billion from a societal perspective. Several biological tear substitutes (e.g., autologous serum (AS), autologous platelet rich plasma (APRP), and autologous platelet lysate (APL)) could effectively improve dry eyes, especially in patients with moderate to severe DED.. However, evidence on their comparative efficacy is controversial. The objective of the study is to compare the efficacy of 100% APRP with 100% AS eye drops in patients with moderate to severe DED.
Detailed description
The study is a single-center, double-blinded randomized, parallel, non-inferiority trial. Patients will be recruited from out-patient clinic, Department of Ophthalmology, Ramathibodi Hospital, Bangkok and will be randomized to receive either 100% APRP or 100% AS eye drops (1:1 ratio) for 4 weeks. The primary outcomes include ocular surface disease index (OSDI) and ocular surface staining evaluated using the Oxford scale. Secondary outcomes are fluorescein break-up time (FBUT), Schirmer's I test (ST I), meibomian gland parameters and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomly allocated to receive either 100% APRP or 100% AS (the same treatment for both eyes).
| Arm | Type | Receives |
|---|---|---|
| 100% APRP | Experimental | Drug: 100% Autologous platelet rich plasmaPatients will be instructed to apply every 2 hours (8 times/day). The currently used bottle will be required to store at 4 C for 24 hours, and the remaining bottles at -20 C in a freezer until day of use. |
| 100% AS | Active comparator | Drug: 100% Autologous serumPatients will be instructed to apply every 2 hours (8 times/day). The currently used bottle will be required to store at 4 C for 24 hours, and the remaining bottles at -20 C in a freezer until day of use. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 18 to less than 75 years.
- Have OSDI scores ≥ 23 or Oxford staining grade ≥ 2.
- Do not have following conditions:
- Uncontrolled systemic diseases, active infection, advanced cancer. Pregnant and nursing women. • Have not recently used the following medications/interventions/surgery: Anticoagulants or anti-platelets. Topical undiluted blood products within 3 months. Punctal plug or contact lenses. Ocular surgery within 6 months.
- Do not have active ocular infection/inflammation, abnormal eyelid function or severe meibomian gland dysfunction (MGD stage 4).
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 100% Autologous platelet rich plasmaAlso: APRPPatients' blood (36 ml per tube) will be collected in three 50-ml sterile centrifuge tubes containing 4 ml of 3.2% buffered citrate acid for anticoagulation. Tubes will be centrifuged at 350 g for 10 minutes at 20 C. The two upper layers of the centrifuged blood, the plasma and the superficial buffy coat, will be separated in a sterile manner under a laminar air flow hood. A 1.5 ml aliquot of both final blood products will be transferred into identical opaque eye drop bottles, labelled name, hospital number, dated and sealed. | Drug | 100% APRP |
| 100% Autologous serumAlso: ASPatients' blood (36 ml per tube) will be collected in three 50-ml sterile centrifuge tubes. The tubes will be left standing in an upright position for 1-2 hours to enable blood clot formation at room temperature (18-25 C). The tubes will be centrifuged at 3000 g for 30 minutes at 20 C. The supernatant serum will be aseptically transferred into a sterile syringe to enable filtration through a 0.2 µm pore size membrane filter under a laminar air flow hood. A 1.5 ml aliquot of both final blood products will be transferred into identical opaque eye drop bottles, labelled name, hospital number, dated and sealed. | Drug | 100% AS |
Primary outcome
Ocular surface score index (OSDI)
Time frame: 4 weeks
The OSDI is a patient-reported outcome (PRO) questionnaire which was designed by Allergan, Inc. to assess range of ocular symptoms related to chronic dry eye disease and reflect patient's ability of function. It comprised 12 questions which are divided into 3 subscales including ocular symptoms (5 questions), vision-related function (4 questions), and environmental triggers (3 questions). Each of question is rated from 0 to 4 indicating none of the time, some of the time, half of the time, most of the time and all of the time, respectively. The average OSDI is transformed into a score ranged from 0 to 100, with a higher score indicating more severity of dry eye disease. The OSDI is classified as normal (0-12 points), mild (13-22 points), moderate (23-32 points) and severe (33-100).
Ocular surface staining (OSS)
Time frame: 4 weeks
To assess total ocular surface staining, the cornea and conjunctival staining are graded by using Oxford scale guidelines (range grade 0 to 5). The higher score refers to higher severity of dry eye.
4 secondary outcomes
Fluorescein break up time (FBUT)
Time frame: 4 weeks
Schirmer's test (ST)
Time frame: 4 weeks
Meibum quality and expressibility.
Time frame: 4 weeks
Number of patients with ocular adverse events
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 39704778Jongkhajornpong P, Lekhanont K, Rattanasiri S, Pisitkun P, Thakkinstian A. Comparison of Corneal Epitheliotrophic Factors of Undiluted Autologous Platelet-Rich Plasma and Autologous Serum Eye Drops for Dry Eye Disease. Ophthalmol Ther. 2025 Feb;14(2):363-377. doi: 10.1007/s40123-024-01082-y. Epub 2024 Dec 20.
- Derived from this study: PubMed 39384222Jongkhajornpong P, Lekhanont K, Rattanasiri S, Numthavaj P, McKay G, Attia J, Thakkinstian A. Efficacy of 100% autologous platelet-rich plasma and 100% autologous serum in dry eye disease: a randomised controlled trial. BMJ Open Ophthalmol. 2024 Oct 8;9(1):e001857. doi: 10.1136/bmjophth-2024-001857.
- Derived from this study: PubMed 34193498Jongkhajornpong P, Numthavaj P, Anothaisintawee T, Lekhanont K, McKay G, Attia J, Thakkinstian A. Comparison of treatment efficacy between 100% platelet-rich plasma and 100% serum eye drops in moderate-to-severe dry eye disease: a randomised controlled trial protocol. BMJ Open. 2021 Jun 30;11(6):e048479. doi: 10.1136/bmjopen-2020-048479.
- Individual participant dataSharing planned: No. Data will be available upon the specific request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ammarin Thakkinstian, Ph.D. study director
Department of Clinical Epidemiology and Biostatistics, Mahidol University, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 100% Autologous platelet rich plasma and 100% Autologous serum in people with Dry Eye Disease, run by Mahidol University at 1 site in Thailand.
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 9 inclusion and 1 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 23 Oct 2023. 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 Thailand. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Ocular surface score index (OSDI) (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 NCT04683796, which also lists 3 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 23 Oct 2023.