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 48 hours, 57% and 81% subjects retained the straight and curved ocular coil, respectively. Four (19%) subjects with the straight coil and six (29%) with the curved coil completed the entire study period. Minor changes in ocular hyperemia were observed in both groups. On day 7, the straight coil was more comfortable than the curved coil with a visual analogue scale (VAS) score of 77 ± 21 compared to 94 ± 11 ( P = 0.028), respectively. No other ocular adverse events were observed. Conclusions Comfort and safety of the straight and curved ocular coil are high. Because the retention time is too short for long-term sustained drug release, the use in the perioperative or immediate postoperative period could prove to be more valuable. Translational Relevance The ocular coil is a noninvasive, comfortable and safe short-term drug delivery device.

Pre-analytical sample handling effects on tear fluid protein levels

“…Tear samples. Tear samples were available from healthy subjects from the Biobank TearFluid Maastricht, University Eye Clinic Maastricht, Maastricht University Medical Center (MUMC+) and from a previously completed clinical trial involving healthy volunteers 32 . The local ethical committee of the Maastricht University Medical Center (MUMC+) approved the study protocols and these studies followed the tenets of the current version of the Declaration of Helsinki.…”