Refitting Satisfied INFUSE One-Day Multifocal Wearers to DAILIES TOTAL1 Multifocal Contact Lenses (INFUSETODT1)

Clinical Outcomes Following Refit From INFUSE One-Day Multifocal to DAILIES TOTAL1 Multifocal in Satisfied Presbyopic Wearers: A Prospective, Open-Label, Single-Arm Study

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

Study Overview

• Status: Recruiting
• Conditions: Presbyopia; Contact Lens Comfort and Successful Refitting
• Intervention / Treatment: Device: DAILIES TOTAL1 Multifocal (delefilcon A)

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Geffen, OD, FAAO; Phone Number: 8584556800; Email: dgeffen@gwsvision.com

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Recruiting
      • Gordon Schanzlin New Vision Institute
      • Contact: David Geffen, OD, FAAO; Phone Number: 858-455-6800; Email: dgeffen@gwsvision.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age ≥40 years at enrollment Current satisfied wearer of Bausch + Lomb INFUSE One-Day Multifocal (kalifilcon A) in both eyes; CLDEQ-8 <12 at baseline Minimum 8 hours/day wear, ≥5 days/week, for ≥30 days prior to Visit 1 Best-corrected distance VA ≥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 ≥8 hours/day, ≥5 days/week and complete all study questionnaires Able to provide written informed consent and follow 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 ≥90 days) History of refractive surgery (LASIK, PRK, RK) or intraocular surgery (cataract/IOL) Clinically significant ectropion, entropion, or trichiasis Baseline corneal fluorescein staining (CFS) >2 in any single zone (NEI/Industry scale) Currently wearing a monovision or modified monovision contact lens fit Pregnant or lactating Participation in any other clinical trial within 30 days of enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: DAILIES TOTAL1 Multifocal; Participants currently wearing INFUSE One-Day Multifocal (kalifilcon A) are refit into DAILIES TOTAL1 Multifocal (delefilcon A) daily disposable contact lenses and followed for approximately 3 weeks.

Device: DAILIES TOTAL1 Multifocal (delefilcon A); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with CLDEQ-8 score <12	he CLDEQ-8 is an 8-item validated questionnaire assessing the frequency and intensity of contact lens-related dryness and discomfort. A score of less than 12 indicates asymptomatic dry eye status. The primary endpoint is the proportion of participants achieving this threshold after 2 weeks on their finalized DAILIES TOTAL1 Multifocal prescription, reported with exact (Clopper-Pearson) 95% confidence intervals.	2 weeks after wearing finalized DAILIES TOTAL1 Multifocal prescription (Visit 3, ~Day 21)

Collaborators and Investigators

• Sponsor: Gordon Schanzlin New Vision
• Collaborators: Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: June 4, 2026
• First Submitted That Met QC Criteria: June 4, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: contact lenses
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: GSNVI-INFUSETODT1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes