Actively Recruiting
Evaluation of Wear Comfort and Vision With Total 30 Multifocal Lenses Over 16 Hours of Wear
Led by Scripps Poway Eyecare and Optometry · Updated on 2026-02-09
36
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Scripps Poway Eyecare and Optometry
Lead Sponsor
S
Sengi
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
Comfort and Vision With TOTAL30 Multifocal Lenses
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Currently wear soft multifocal contact lenses and score less than 12 on the CLDEQ-8 survey.
- Are 40 years of age or older.
- Can wear contact lenses for at least 13 hours daily and up to 16 hours on questionnaire days.
- Willing to insert contact lenses between 6:00 am and 8:00 am on questionnaire days.
- Vision correctable to 20/25 (0.10 log MAR) or better in each eye at 6 meters with soft multifocal lenses.
- Able to be fitted with the prescription parameters of the Total30 Multifocal lenses.
- Own a smartphone capable of receiving push notifications.
- Willing to attend all study visits.
- Willing to promptly answer timed surveys.
You will not qualify if you...
- Have ocular anterior segment infection, inflammation, abnormality, or active disease contraindicating contact lens wear.
- Use systemic or ocular medications contraindicating contact lens wear.
- Use isotretinoin derivatives.
- Use lubricating eye drops.
- Are monocular or wear only one multifocal lens.
- Have had prior refractive surgery.
- History of herpetic keratitis, ocular surgery, or irregular cornea.
- Are pregnant or lactating.
- Participated in a clinical trial within the past 30 days.
- Habitual high-ADD wearers using fitting methods other than Alcon's multifocal guide.
- Past wearers of rigid contact lenses.
- Diagnosed with dry eye or ocular allergies.
- History of severe ocular trauma.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 30 days
Participants wear the TOTAL30 Multifocal lenses and provide feedback on comfort and vision quality during 16 hours of wear on specified days over a 30-day period.
Questionnaire days with daily wear and surveys
Trial Site Locations
Total: 1 location
1
Scripps Optometric Group
San Diego, California, United States, 92131
Actively Recruiting
Research Team
L
Leslie Shan
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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