Safety and Comfort of an Innovative Drug Delivery Device in Healthy Subjects.

ABSTRACT:

Purpose

The aim of this study was to investigate safety and comfort of two versions of a placebo-microsphere filled ocular coil (straight and curved) in healthy subjects.

Methods

The study was a single-center intervention study. One ocular coil was placed in the inferior conjunctival fornix for the intended duration of 28 days. Forty-two healthy adult subjects were included. At baseline, 30 minutes, 8 hours, 24 hours, 48 hours, 7 days, 14 days, 21 days, and 28 days after insertion, examinations were performed, including slit lamp evaluation to score ocular redness, intraocular pressure measurement, visual acuity, tear secretion test, and questionnaires.

Results

The straight and curved ocular coils had a median retention time of 5 days and 12 days, respectively. After

SUBMITTER: Bertens CJF 

PROVIDER: S-EPMC7757610 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature