PURPOSE: While silicone hydrogel contact lenses (CLs) have gained favor among eye care practitioners (ECPs) in recent years, conventional hydrogel CLs continue to represent a meaningful proportion of CLs used in real-world practice. The nesofilcon A daily disposable CL (Biotrue ONEday, BTOD) consists of a unique hydrogel material with a highly hydrophilic polymer (polyvinylpyrrolidone) yielding a CL with the same water content as the human cornea (78%) and a patented dehydration barrier (poloxamer 407) to retain moisture for up to 16 hours and mimic the tear film lipid layer for a smooth optical surface. This meta-analysis evaluated results, including key safety assessments, across key registrational trials that included the BTOD lens which, together, span nearly a decade.

METHODS: This meta-analysis included three 3-month randomized multicenter registrational clinical trials (all in ClinicalTrials.gov) that have evaluated the safety and effectiveness of BTOD, including the first ever registrational study of BTOD as well as 2 subsequent studies of BTOD and BTOD for astigmatism, respectively. Here we report on key results for BTOD in these studies: participant demographics, as well as safety outcomes including slit lamp findings and adverse events. Descriptive data (n [%]) are reported.

RESULTS: A total of 338 participants (676 eyes) who wore BTOD CLs were analyzed across the three studies (N=87 [174 eyes], N=128 [256 eyes], N=123 [246 eyes] in each study individually; intent-to-treat population). Participants were between 18–59 years of age (18–40, 18–55, and 19–59 years) with the majority being female (64.4%, 74.2%, and 63.4%). Over 3 months of follow-up across all studies, BTOD demonstrated robust safety: across all study visits and accounting for a total of over 2,000 documented eye assessments, no significant changes in ocular condition or slit lamp findings >Grade 2 were reported. Incidence of treatment-emergent ocular adverse events was also low across studies (none serious or resulting in discontinuation).

CONCLUSIONS: The present findings in a large population derived from key registrational studies with BTOD, which were conducted over the course of nearly a decade, demonstrate the robust and consistent safety of BTOD when used daily by soft CL wearers. Such insights are valuable to affirm the benefits that a hydrogel daily disposable CL such as BTOD can offer to both patients and ECPs.