drugset / Trial / NCT04683796

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

NCT04683796

Phase 3 Completed 96 enrolled Mahidol University
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2021-02-01
Primary completion
2023-02-28
Completion
2023-03-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Autologous serum Unknown 100 % Other
Subject Platelet Rich Plasma Other / unclassified 100 % Other

Indications