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NCT Number: NCT04683796

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

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.

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ophthalmology Department, Ramathibodi Hospital

Ratchathewi, Bangkok, 10400, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • None

Treatment and study plan

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.

Other names: 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.

Other names: AS

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. Fluorescein break up time (FBUT)

    Time frame: 4 weeks

    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.

  2. Schirmer's test (ST)

    Time frame: 4 weeks

    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.

  3. Meibum quality and expressibility.

    Time frame: 4 weeks

    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.

  4. Number of patients with ocular adverse events

    Time frame: 4 weeks

    All ocular adverse events will be recorded throughout the study.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 24, 2020
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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