Comparison of Efficacy Between 100% Platelet-rich Plasma and 100% Serum Eye Drops in Dry Eye Disease

NCT04683796 | Completed Phase 3

• 1 other identifier: 1996
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  4 weeks

Secondary Outcomes (4)

• Fluorescein break up time (FBUT)

  4 weeks

• Schirmer's test (ST)

  4 weeks

• Meibum quality and expressibility.

  4 weeks

• Number of patients with ocular adverse events

  4 weeks

Study Arms (2)

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.

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.

Drug: 100% Autologous serum

Interventions

100% Autologous platelet rich plasma DRUG

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.

Also known as: APRP

100% APRP

100% Autologous serum DRUG

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.

Also known as: AS

100% AS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Ophthalmology Department, Ramathibodi Hospital

Ratchathewi, Bangkok, 10400, Thailand

Location

Related Publications (3)

• 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.

  PMID: 39704778 DERIVED

• Jongkhajornpong 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.

  PMID: 39384222 DERIVED

• Jongkhajornpong 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.

  PMID: 34193498 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Ammarin Thakkinstian, Ph.D.

  Department of Clinical Epidemiology and Biostatistics, Mahidol University, Thailand

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Treatment package will be labelled as randomization number. Participants will also be blinded to the treatments they receive by using the identical type of eye drop bottle. Clinical and research staffs involved in the outcome assessments will be blinded to the treatment allocation. Lastly, data analysts will also be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Ophthalmology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University

Model Details: Patients will be randomly allocated to receive either 100% APRP or 100% AS (the same treatment for both eyes).

Study Record Dates

• First Submitted: December 20, 2020
• First Posted: December 24, 2020
• Study Start: February 1, 2021
• Primary Completion: February 28, 2023
• Study Completion: March 30, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)