Comparison of Efficacy Between 100% Platelet-rich Plasma and 100% Serum Eye Drops in Dry Eye Disease
Condition: Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Study type: Interventional
Phase: Phase 3

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.
    

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.
    

Intervention name(s): 100% Autologous platelet rich plasma; 100% Autologous serum
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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 intervention name(s): APRP; AS
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomly allocated to receive either 100% APRP or 100% AS (the same treatment for both eyes).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment