Clinical trial
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
Name
1996
Description
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.
Trial arms
Trial start
2021-02-01
Estimated PCD
2023-02-28
Trial end
2023-03-30
Status
Completed
Phase
Early phase I
Treatment
100% Autologous platelet rich plasma
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.
Arms:
100% APRP
Other names:
APRP
100% Autologous serum
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.
Arms:
100% AS
Other names:
AS
Size
96
Primary endpoint
Ocular surface score index (OSDI)
4 weeks
Ocular surface staining (OSS)
4 weeks
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomly allocated to receive either 100% APRP or 100% AS (the same treatment for both eyes).', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 96, 'type': 'ACTUAL'}}
Updated at
2023-10-23
1 organization
Organization
Mahidol University