Comfort and Vision With TOTAL30 Multifocal Lenses (NCT07284966) | Clinical Trial Compass
RecruitingNot Applicable
Comfort and Vision With TOTAL30 Multifocal Lenses
United States36 participantsStarted 2026-02-05
Plain-language 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.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 exclusion criteria are applicable, the subject should not be enrolled in the study.
* Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.
* Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator.
* Use of isotretinoin-derivatives.
* Use of lubricating drops.
* Monocular patients or patients fit with only 1 multifocal lens.
* Prior refractive surgery.
* History of herpetic keratitis, ocular…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient-reported comfort level of the TOTAL30 Multifocal Lens
Timeframe: 16 hours of wear on specified days over a 30-day period