Recruiting

DAILIES TOTAL1 & INFUSE

Sponsor:

Gordon Schanzlin New Vision

Code:

NCT07638943

Conditions

Contact Lens Comfort and Successful Refitting

Presbyopia

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Accepted

Interventions

DAILIES TOTAL1 Multifocal (delefilcon A)

Study Details

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

Contact Lens Comfort and Successful Refitting

Presbyopia

Study ID

NCT07638943

Start date

May 20, 2026

Status verified date

Jun, 2026

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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 measure

  • 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) ]

Central Contacts and Locations

Central contacts

David Geffen, OD, FAAO

8584556800dgeffen@gwsvision.com

Locations

Gordon Schanzlin New Vision Institute

Recruiting

La Jolla, California, United States, 92037

Contacts

More Information

Sponsor

Gordon Schanzlin New Vision

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Keywords

  • contact lenses

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Gordon Schanzlin New Vision on 2026-06-11.