Evaluation of Wear Comfort and Vision With Total 30 Multifocal Lenses Over 16 Hours of Wear
Scripps Poway Eyecare and Optometry
Summary
This study is a single-arm, prospective, observational study conducted at one site to evaluate the comfort and vision of the TOTAL30 Multifocal (T30MF) contact lenses over the course of long wear days. The study will assess the proportion of positive subjective Visual Analog Scale (VAS) assessments of comfort and vision at 10, 12, 14, and 16 hours of wear on Days 1, 7, 14, and 30. Additionally, the study will explore subjective assessments of lens comfort using the CLDEQ-8 survey and measure logMAR visual acuity at both distance and near at Visit 1, Visit 2, and after 1 month of lens wear. Participants will undergo three site visits, with at-home surveys conducted at specified intervals to gather real-time data on comfort and vision.
Eligibility
- Age range
- 40+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Subjects are eligible for the study if they meet the following criteria: * Subjects who currently wear soft multi-focal contact lenses and score \<12 on an entering CLDEQ-8 survey. * Subjects who are \>= 40 years old. * Subjects who can and are willing to wear their lenses for 13 hours per day during the study period, and 16 hours per day when questionnaires are being taken. * Willing to insert their contact lenses between 6:00 am and 8:00 am on the days when questionnaires will be taken. * Vision correctable in soft multi-focal contact lenses to 20/25 (0.10 log MAR) or b…
Interventions
- DeviceTOTAL30 Multifocal
TOTAL30 Multifocal
Location
- Scripps Optometric GroupSan Diego, California