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Recruiting

NCT Number: NCT07638943

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

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

Recruiting

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gordon Schanzlin New Vision Institute

La Jolla, California, 92037, United States

Location status: Recruiting

Location contact

David Geffen, OD, FAAO

CONTACT

[email protected]

858-455-6800

About this study

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.

Who can participate

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

Treatment and study plan

DAILIES TOTAL1 Multifocal (delefilcon A)

Device

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.

Primary outcomes

  1. Proportion of participants with Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score <12

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

David Geffen, OD, FAAO

CONTACT

[email protected]

8584556800

Sponsors and collaborators

Lead sponsor

Gordon Schanzlin New Vision

Other

Collaborators

  • Alcon Research

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 10, 2026
Registry last updated
Jun 11, 2026

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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