Adverse Events With Daily Wear Of Silicone Hydrogel Contact Lenses In Chinese Children

Abstract

Purpose: : To report on the incidence and type of adverse events in a group of Chinese children wearing silicone hydrogel contact lenses (CL) over a 12 month period.

Methods: : In a prospective clinical trial, 240 children, aged 8 to 14 yrs were enrolled to wear silicone hydrogel CL (Lotrafilcon B, both single vision and novel myopia control CL) on a daily wear, monthly replacement schedule. The trial was part of Vision CRC myopia control studies conducted at Zhongshan Ophthalmic Centre, Guangzhou, China. Adverse events observed during the 12 month period were categorised using the BHVI/LVPEI categorisation system as Serious, Significant and Non-significant events. The total number of patient eye years in the study was determined. Incidence was calculated as the number of adverse events divided by the total number of patient eye years and reported as Incidence per 100 patient eye years (Incidence %).

Results: : The number of patient eye years in the study was 411. There were no serious adverse events. The incidence of first events of significant and non- significant adverse events was 7.5% and 1.5% respectively. Of the significant events, incidence of inflammatory/ infiltrative events was 0.7% and included 3 events of Infiltrative Keratitis. The incidence of significant mechanical events was 7.1% and included Contact Lens Papillary Conjunctivitis (12 events, 2.9%), Superior Epithelial Arcuate Lesions (8 events, 1.9%) and Corneal Erosions (9 events, 2.2%). One subject had both SEALs and IK. The non-significant events were Asymptomatic Infiltrative Keratitis (2 events, 0.5%) and Asymptomatic Infiltrates (4 events, 1.0%). None of the events resulted in any loss of best corrected visual acuity or discontinuation from lens wear. When recurrent events were also considered, the incidence of significant and non- significant events increased slightly to 8.5 % and 1.9% respectively.

Conclusions: : Mechanical events were the most frequently observed events. Overall, the low incidence of adverse events observed with daily wear use of silicone hydrogel CL is promising for CL wear as a modality for vision correction in children. However, it is important to understand the mechanisms underlying these events to try to further decrease their incidence especially as reduction in the rate of myopia progression has been observed with novel myopia control CL.

Clinical Trial: : http://www.chictr.org ChiCTR-TRC-00000232

Keywords: contact lens • myopia • clinical (human) or epidemiologic studies: prevalence/incidence