The short-term physiological impact of switching reusable silicone hydrogel wearers into a hydrogel daily disposable multifocal

• Published in: Clinical ophthalmology (Auckland, N.Z.) Vol. 13; pp. 1193 - 1202
• Main Authors: Moezzi, Amir M, Varikooty, Jalaiah, Luensmann, Doerte, Schulze, Marc-Matthias, Ng, Alison, Karkkainen, Thomas, Xu, Jing, Jones, Lyndon
• Format: Journal Article
• Language: English
• Published: New Zealand Dove Medical Press Limited 01.07.2019; Taylor & Francis Ltd; Dove; Dove Medical Press
• Subjects: Contact lenses; Corneal swelling; daily disposable; hydrogel lens; Hydrogels; Hypoxia; limbal hyperemia; multifocal lens; OCT; Ophthalmology; Original Research; oxygen transmissibility; Patients; Pharmaceutical industry; Physiological aspects; Presbyopia; silicone hydrogel lens; Silicones; Canada; United States; OCT; oxygen transmissibility; corneal thickness; limbal hyperemia; presbyopia; corneal swelling
• ISSN: 1177-5467; 1177-5483; 1177-5483
• DOI: 10.2147/OPTH.S208905

To evaluate ocular physiological responses to etafilcon A multifocal (etMF) daily disposable (DD) lenses after 4 weeks of wear, when switching from habitual silicone hydrogel (SiHy) daily wear. A single-arm, open-label, bilateral dispensing study was conducted in 39 habitual spherical SiHy wearers (14 hyperopes; 25 myopes). Clinical visits occurred with habitual SiHy (control) at baseline and after 4 weeks of etMF DD open-eye lens wear at exit. Objective limbal/bulbar hyperemia using the Oculus K5M (0-4) and subjective grading of lid wiper epitheliopathy (LWE) (0-4) were tested for non-inferiority (NI), using a margin of 1 grade. Corneal thickness along a 10 mm cord was measured using the Visante OCT and tested for NI using a 30 μm margin. Corneal staining area was graded (0-100%). The least-square mean differences (LSMD) and 95% confidence interval (95% CI) between etMF DD and habitual SiHy in central and peripheral corneal thickness (μm) were 3.64 (-2.0, 9.29) and 3.0 (-7.72, 13.72) in hyperopic, and 3.56 (-0.66, 7.78) and 6.40 (-1.62, 14.42) in myopic subjects. The LSMD (95% CI) for bulbar and limbal hyperemia were -0.08 (-0.19, 0.02) and -0.01 (-0.12, 0.09) in hyperopes, and 0.04 (-0.03, 0.12) and 0.04 (-0.04, 0.11) in myopes. The LSMD (95% CI) for LWE were 0.11 (-0.39, 0.60) and 0.30 (-0.07, 0.67) for hyperopes and myopes, respectively. No clinically significant differences in a variety of physiological responses were found when habitual reusable SiHy daily wear subjects were refitted into hydrogel etMF, when the subjects were followed for 4 weeks.