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

NCT07638943 | Recruiting FDA Device

• 1 other identifier: GSNVI-INFUSETODT1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Presbyopia; Contact Lens Comfort and Successful Refitting

Keywords

contact lenses

Outcome Measures

Primary Outcomes (1)

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

  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.

  2 weeks after wearing finalized DAILIES TOTAL1 Multifocal prescription (Visit 3, ~Day 21)

Study Arms (1)

DAILIES TOTAL1 Multifocal

EXPERIMENTAL

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)

Interventions

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.

DAILIES TOTAL1 Multifocal

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gordon Schanzlin New Vision: lead
• Alcon Research: collaborator

Study Sites (1)

Gordon Schanzlin New Vision Institute

La Jolla, California, 92037, United States

RECRUITING

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

David Geffen, OD, FAAO

CONTACT

8584556800; dgeffen@gwsvision.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 10, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: June 11, 2026

Record last verified: 2026-06

Locations

US (1)