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NCT07638943NARecruitingAccepts Healthy Volunteers

Refitting Satisfied INFUSE One-Day Multifocal Wearers to DAILIES TOTAL1 Multifocal Contact Lenses

Gordon Schanzlin New Vision

Start Date

5/20/2026

Completion Date

2/28/2027

Summary

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

Detailed Description

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.

Eligibility Criteria

Age Range: 40 years to No maximum

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

Interventions

DEVICE

DAILIES TOTAL1 Multifocal (delefilcon A)

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Conditions

Contact Lens Comfort and Successful RefittingPresbyopia

Locations

Gordon Schanzlin New Vision Institute

La Jolla, California 92037

United States