TY - JOUR
T1 - Safety and Comfort of an Innovative Drug Delivery Device in Healthy Subjects
AU - Bertens, C.J.F.
AU - Dunker, S.L.
AU - Dias, A.J.A.A.
AU - van den Biggelaar, F.J.H.M.
AU - Nuijts, R.M.M.A.
AU - Gijs, M.
N1 - Funding Information:
The authors declare that they have no known competing financial interests that could have appeared to influence the work reported in this paper. A. Dias, PhD, is the co-founder of Eyegle bv. This research was performed under the framework of the Chemelot Institute for Science and Technology (InSciTe). The authors would like to thank Lindsay Spekreijse, MD, Ilona Liesenborghs, MD, Pascal Vroemen, MD, Claudette Veldhuizen, MD, Rob Simons, MD, Nathalia Makhotkina, MD, and Nienke Visser, MD, PhD, from the University Eye Clinic Maastricht for their contribution during the examinations of the subjects. We would also like to thank Bjorn Winkens, PhD, and Tos Berendschot, PhD, for their help on the statistical part of the manuscript.
Publisher Copyright:
© 2020 The Authors.
PY - 2020/12/1
Y1 - 2020/12/1
N2 - 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.
AB - 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.
KW - clinical study
KW - comfort and safety study
KW - corneal
KW - cystoid macular edema
KW - design
KW - dropless cataract-surgery
KW - eye
KW - intracanalicular insert
KW - management
KW - ocular coil
KW - ophthalmology
KW - pain
KW - placebo drug delivery device
KW - prevention
KW - tolerance
KW - DESIGN
KW - TOLERANCE
KW - EYE
KW - INTRACANALICULAR INSERT
KW - MANAGEMENT
KW - PREVENTION
KW - CORNEAL
KW - DROPLESS CATARACT-SURGERY
KW - PAIN
KW - CYSTOID MACULAR EDEMA
U2 - 10.1167/tvst.9.13.35
DO - 10.1167/tvst.9.13.35
M3 - Article
C2 - 33384889
SN - 2164-2591
VL - 9
JO - Translational Vision Science & Technology
JF - Translational Vision Science & Technology
IS - 13
M1 - 35
ER -