Christian J F Bertens1, Suryan L Dunker2,3, Aylvin J A A Dias1,4, Frank J H M van den Biggelaar1,2, Rudy M M A Nuijts1,2, Marlies Gijs1. 1. Chemelot Institute for Science and Technology (InSciTe), GS Maastricht, The Netherlands. 2. University Eye Clinic Maastricht, Maastricht University Medical Center+ (MUMC+), HX Maastricht, The Netherlands. 3. Maastricht University, School for Mental Health and Neuroscience, University Eye Clinic Maastricht, ER Maastricht, The Netherlands. 4. Eyegle bv. Gerbergaplantsoen 11, Maastricht, The Netherlands.
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. Copyright 2020 The Authors.
RCT Entities:
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. Copyright 2020 The Authors.
Entities:
Keywords:
clinical study; comfort and safety study; ocular coil; ophthalmology; placebo drug delivery device
Authors: James D Brandt; Harvey B DuBiner; Robert Benza; Kenneth N Sall; Gary A Walker; Charles P Semba Journal: Ophthalmology Date: 2017-05-17 Impact factor: 12.079
Authors: Laura H P Wielders; Jan S A G Schouten; Merel R Aberle; Verena A Lambermont; Frank J H M van den Biggelaar; Bjorn Winkens; Rob W P Simons; Rudy M M A Nuijts Journal: J Cataract Refract Surg Date: 2017-02 Impact factor: 3.351
Authors: Joseph P Gira; Reginald Sampson; Steven M Silverstein; Thomas R Walters; Jamie Lynne Metzinger; Jonathan H Talamo Journal: Patient Prefer Adherence Date: 2017-03-08 Impact factor: 2.711