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

PHASE3CompletedINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

February 1, 2021

Primary Completion Date

February 28, 2023

Study Completion Date

March 30, 2023

Conditions
Dry Eye Disease
Interventions
DRUG

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.

DRUG

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.

Trial Locations (1)

10400

Ophthalmology Department, Ramathibodi Hospital, Ratchathewi

All Listed Sponsors
lead

Mahidol University

OTHER

NCT04683796 - Comparison of Efficacy Between 100% Platelet-rich Plasma and 100% Serum Eye Drops in Dry Eye Disease | Biotech Hunter | Biotech Hunter