Actively Recruiting
Comfort and Vision With TOTAL30 Multifocal Lenses
Led by Scripps Poway Eyecare and Optometry · Updated on 2026-02-09
36
Participants Needed
1
Research Sites
50 weeks
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
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.
CONDITIONS
Official 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 at entry
- Are 40 years old or older
- Able and willing to wear lenses 13 hours per day during the study and 16 hours per day on questionnaire days
- Willing to insert lenses between 6:00 am and 8:00 am on questionnaire days
- Vision correctable to 20/25 (0.10 logMAR) or better in each eye at 6 meters with soft multifocal lenses
- Able to be successfully fitted with the prescription parameters available for Total30 Multifocal lenses
- Have a smartphone and can receive push notifications
- Willing to attend all study visits
- Willing to answer timed surveys promptly
You will not qualify if you...
- Ocular anterior segment infection, inflammation, abnormality, or active disease contraindicating contact lens wear
- Use of systemic or ocular medications that contraindicate contact lens wear
- Use of isotretinoin derivatives
- Use of lubricating eye drops
- Monocular patients or those fitted with only one multifocal lens
- Prior refractive surgery
- History of herpetic keratitis, ocular surgery, or irregular cornea
- Pregnant or lactating
- Participation in another clinical trial within the past 30 days
- High-add habitual wearers using fitting approaches other than Alcon's multifocal guide
- Past rigid contact lens wearers
- History of 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
Trial Site Locations
Total: 1 location
1
Scripps Optometric Group
San Diego, California, United States, 92131
Actively Recruiting
Research Team
L
Leslie Shan
CONTACT
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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