Ocular health of children wearing daily disposable contact lenses over a 6-year period. Issue 4 (August 2021)

• Record Type: Journal Article
• Authors: Woods, Jill; Jones, Debbie; Jones, Lyndon; Jones, Susanna; Hunt, Chris; Chamberlain, Paul; McNally, John
• Is Part Of: Contact lens & anterior eye. Volume 44:Issue 4(2021)
• Publication Date: 2021-08
• Subjects: Neophyte -- Children -- Soft contact lenses -- Safety profile -- Adverse events -- MiSight; Anterior segment (Eye) -- Periodicals; Contact lenses -- Periodicals; Segment antérieur (Œil) -- Périodiques; Lentilles de contact -- Périodiques; 617.752305
• DOI: 10.1016/j.clae.2020.11.011
• Languages: English
• ISSNs: 1367-0484

Abstract

Abstract: Purpose: To report on the ocular health and safety of children fit with soft hydrogel daily-disposable contact lenses, and followed for 6-years in a double-masked clinical trial investigating the performance of a dual-focus contact lens designed to control myopia progression. Methods: Children aged 8−12 years, naïve to contact lens wear, were enrolled across four international sites. During years 1–3, children were randomised to either MiSight® 1 day or Proclear® 1 day (both omafilcon A, CooperVision, Inc.). The lenses were identical in material and geometry except for the front optical zone design. At the end of year-3, all those wearing Proclear 1 day were switched to MiSight 1 day, therefore all wore MiSight 1 day in years 4−6. Subjects agreed to wear the lenses at least 10-hours/day, 6-days/week. After dispensing, study visits were at 1-week, 1-month, 6-months and every 6-months until 6-years. At each visit, ocular measurements and subjective responses were recorded. Biomicroscopy used 0–4 grading scales; grade 0 represented no findings. Results: 144 children were enrolled: 69F:75M; mean age 10.1 years; mean cycloplegic spherical-equivalent refraction -2.11D; ethnicities included 34 East-Asian, 12 West-Asian, and 79 Caucasian. 92 completed the 6-years. Only three subjects discontinued due to an ocular adverse event (AE). No contact lens related AEs were classified as serious. The incidence rate of infiltrative AEs was 0.61% (6.1/1000 wearing-years; 95%CI: 0.24%–1.57%). The most common biomicroscopy findings were limbal, bulbar and tarsal hyperaemia and tarsal roughness. 99% of all biomicroscopy findings were grade-1 or lower. After 6-years of lens wear, ocular health by biomicroscopy was similar to pre-lens wear. Conclusions: Across the 6-years, there were no contact lens related serious AEs and biomicroscopy showed no significant changes. Results suggest that children this age can successfully wear daily-disposable hydrogel contact lenses with minimal impact on ocular physiology.