NCT07638943 · Gordon Schanzlin New Vision
Refitting Satisfied INFUSE One-Day Multifocal Wearers to DAILIES TOTAL1 Multifocal Contact Lenses
(INFUSETODT1)
What this study is about
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
View original scientific description
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
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)
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- La Jolla, California
Collaborators
Alcon Research
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 11, 2026 · Source of record for eligibility and locations