Gordon Schanzlin New Vision Institute
La Jolla, California, 92037, United States
Location status: Recruiting
NCT Number: NCT07638943
The purpose of this study is to determine the comfort and vision of DAILIES TOTAL1 Multifocal contact lenses in a population of satisfied INFUSE One-Day Multifocal contact lens wearers
Interested in participating?
Request Info40 year and older
All sexes
Interventional
Not applicable
La Jolla, California, 92037, United States
Location status: Recruiting
There is a paucity of data on the wear experience of DAILIES TOTAL1 Multifocal contact lenses in a population that has previously worn INFUSE One-Day Multifocal. While existing multifocal lenses provide adequate refractive correction, they often fail to maintain the complex biochemical homeostasis of the aging tear film, leading to significant "end-of-day" discomfort and fluctuating vision as the lens surface dehydrates. There remains a critical clinical need for a lens material that doesn't simply offer physical lubrication, but actively mimics the eye's natural environment-either through a high-oxygen water gradient surface to minimize mechanical friction or the infusion of osmoprotectants and electrolytes to prevent hyperosmotic stress. This study addresses the gap in providing a sustainable, all-day wearing experience that preserves both physiological health and the precise optical clarity required for multifocal success.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Age ≥40 years at enrollment Current satisfied wearer of Bausch + Lomb INFUSE One-Day Multifocal (kalifilcon A) in both eyes; Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score <12 at baseline Minimum contact lens wear of ≥8 hours/day, ≥5 days/week, for ≥30 days prior to Visit 1 Best-corrected distance visual acuity ≥20/25 (0.18 LogMAR) or better in each eye Manifest refraction within study lens parameters (Sphere: +6.00 D to -10.00 D; Add: Low, Medium, High) Willing to wear DAILIES TOTAL1 Multifocal lenses for ≥8 hours/day, ≥5 days/week and complete all study questionnaires Able to provide written informed consent and comply with investigator instructions
Exclusion criteria
Active ocular infection, inflammation, or clinically significant ocular surface disease (e.g., severe dry eye, pterygium, keratoconus) Uncontrolled systemic disease or use of systemic medications known to significantly affect the tear film, unless on a stable dose for ≥90 days History of refractive surgery (LASIK, PRK, RK) or intraocular surgery (cataract or IOL implantation) Clinically significant ectropion, entropion, or trichiasis Baseline corneal fluorescein staining score >2 in any single zone (NEI/Industry scale) Current monovision or modified monovision contact lens wear Pregnant or lactating participants Participation in another clinical trial within 30 days prior to enrollment
Daily disposable multifocal contact lens refit to match the participant's habitual INFUSE One-Day Multifocal power and add level. Worn a minimum of 8 hours/day, at least 5 days/week for approximately 3 weeks. A mandatory ~15-minute equilibration period is required before over-refraction at the fitting visit. Power is finalized at Visit 2 if adjustment is needed; the primary endpoint is assessed after 2 weeks on the finalized prescription.
Time frame: 2 weeks after wearing finalized DAILIES TOTAL1 Multifocal prescription (Visit 3, ~Day 21)
The Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) is an 8-item validated questionnaire assessing the frequency and intensity of contact lens-related dryness and discomfort. Total scores range from 0 to 37, with higher scores indicating greater dryness and discomfort (worse symptoms). A score of less than 12 indicates asymptomatic status.
The primary endpoint is the proportion of participants achieving a CLDEQ-8 score <12 after 2 weeks on their finalized DAILIES TOTAL1 Multifocal prescription. Results will be reported with exact (Clopper-Pearson) 95% confidence intervals.
Contact information is provided by the study sponsor or research team.
Gordon Schanzlin New Vision
Other
Clinical Outcomes Following Refit From INFUSE One-Day Multifocal to DAILIES TOTAL1 Multifocal in Satisfied Presbyopic Wearers: A Prospective, Open-Label, Single-Arm Study
Acronym: INFUSETODT1
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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