Adverse events with daily wear of silicone hydrogel (Lotrafilcon B) contact lenses in Chinese children: 2 Year Results

Abstract

Purpose: : To report the incidence and type of adverse events in a group of Chinese children wearing silicone hydrogel contact lenses (CL) over 2 years.

Methods: : Children aged 8 to 14 yrs were enrolled in a prospective clinical trial to wear silicone hydrogel CL (both single vision and novel myopia control CL) on a daily wear, peroxide disinfection (Clear Care® , CIBA VISION), monthly replacement schedule as part of Vision CRC myopia control studies. The trial was conducted at Zhongshan Ophthalmic Centre, Guangzhou, China. Adverse events observed during the 2 year period with wear of the control, single vision, commercially available contact lens design (Lotrafilcon B, CIBA VISION) in 63 children 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 for 2 years was 215. There were no events of microbial keratitis. The incidence of significant and non-significant adverse events (includes recurrent events) was 5.1% and 7.0% respectively. Of the significant events, incidence of inflammatory/ infiltrative events was 1.9% and included 4 events of Infiltrative Keratitis. The incidence of Contact Lens Papillary Conjunctivitis was 2.3% (5 events with 1 recurrent event) and Corneal erosions was 0.9% ( 2 events with no recurrence). Non-significant events were Asymptomatic Infiltrative Keratitis (4.2%, 9 events with 2 recurrent events) and Asymptomatic Infiltrates (2.8%, 6 events with no recurrence). Eyes with asymptomatic infiltrates did not require any intervention and continued in CL wear. Others were managed by temporary discontinuation from CL wear. Only one of the 15 participants with events discontinued (6.7%, p=0.162).

Conclusions: : After 2 years of daily wear of a silicone hydrogel (Lotrafilcon B) in children, the incidence of adverse events was low. The incidence is comparable to published reports of adverse events with daily wear in adults and suggests that children are not at a greater risk of developing adverse events with CL wear.

Clinical Trial: : http://www.chictr.org 00000232

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