A Randomized Trial of Topical Fibrinogen-Depleted Human Platelet Lysate Treatment of Dry Eye Secondary to Chronic Graft-versus-Host Disease.

ABSTRACT:

Purpose

The purpose of the study was to evaluate, as a pilot trial, safety and tolerability of CAM-101 10% and 30% topical ophthalmic fibrinogen-depleted human platelet lysate (FD hPL) solution in patients with dry eye disease (DED) secondary to graft-versus-host disease (GvHD) after 6 weeks of treatment.

Design

A phase I/II, pilot, prospective, multicenter, randomized, double-masked clinical trial.

Participants

Patients with DED secondary to GvHD.

Methods

Sixty-four adult patients were stratified by "symptom severity" (Ocular Surface Disease Index [OSDI], ocular discomfort Visual Analog Scale (VAS), ocular symptom frequency, and use of artificial tears) and then randomized 1:1:1 to CAM-101 (FD hPL) at 10% or 30% concentration or an electrolyte (Plasma-Lyte A)

SUBMITTER: Sugar A 

PROVIDER: S-EPMC9562362 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature