Study of Comfort and Vision Using TOTAL30 Multifocal Contact Lenses Worn for Up to 16 Hours a Day Over One Month

What this Trial Is About

Researchers are evaluating the comfort and vision provided by the TOTAL30 Multifocal contact lenses during extended wear in adults aged 40 and older who currently wear soft multifocal lenses. This single-arm, observational study aims to understand how well these lenses perform over long wear times, focusing on subjective comfort and vision quality. The study also uses surveys and visual acuity tests to explore the real-world experience of lens wear in people with myopia, presbyopia, and astigmatism. Participants will wear the TOTAL30 Multifocal lenses and provide feedback on their comfort and vision at 10, 12, 14, and 16 hours of wear on Days 1, 7, 14, and 30. The study involves three site visits to assess vision using logMAR visual acuity tests at distance and near. In addition to these visits, participants will complete at-home surveys that collect real-time data on lens comfort and vision, including the CLDEQ-8 survey for subjective comfort evaluation. Throughout the study, participants are expected to wear the lenses for 13 hours daily and up to 16 hours on days when surveys are collected. Researchers will monitor patient-reported comfort and vision quality over the 30-day period. The study includes regular assessments through questionnaires and vision tests to measure outcomes related to lens comfort and visual performance. Participants must have a smartphone to receive survey notifications and must attend all scheduled visits and respond promptly to surveys.

Comfort and Vision With TOTAL30 Multifocal Lenses