Refitting Satisfied INFUSE One-Day Multifocal Wearers to DAILIES TOTAL1 Multifocal Contact Lenses
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DAILIES TOTAL1 Multifocal (delefilcon A).
- Who it may be relevant to
- Registry conditions: Contact Lens Comfort and Successful Refitting, Presbyopia. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Interventions
- 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.
Primary outcome measures
- 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)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Gordon Schanzlin New Vision Institute — La Jolla
Identifiers
NCT: NCT07638943 · GSNVI-INFUSETODT1