Astigmatism, Myopia, Presbyopia
Conditions
Brief 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.
Interventions
DEVICETOTAL30 Multifocal
TOTAL30 Multifocal
Sponsors
Scripps Poway Eyecare and Optometry
Sengi
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
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 better in each eye at 6M. * Must be able to be successfully fit into the prescription parameters available for Total30 MF contact lenses. * Required to have a smartphone and receive push notifications. * Willing to attend all study visits. * Willing to be diligent about answering the timed surveys in a prompt manner.
Exclusion criteria
If any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported comfort level of the TOTAL30 Multifocal Lens | 16 hours of wear on specified days over a 30-day period | Comfort level assessed using real-time patient-reported data collected at multiple time points throughout the day, with a focus on the end of the wear period. Patients are asked "What is your impression of the COMFORT of these study lenses?" and provide and answer from -50 (Extremely uncomfortable) to +50 (Extremely comfortable) using a sliding digital scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported vision quality with the TOTAL30 Multifocal Lens | 16 hours of wear on specified days over a 30-day period | Vision quality assessed using real-time patient-reported data collected at various time points during the day. Patients are asked "What is your impression of the VISION quality of these study lenses?" and provide and answer from -50 (Poor quality) to +50 (Excellent quality) using a sliding digital scale. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJay Mashouf, OD
Scripps Optometric Group
Outcome results
None listed