[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07638943":3,"trial-entities:NCT07638943":75,"trial-summary:NCT07638943":78},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":37,"secondary_outcomes":42,"sex":43,"minimum_age":44,"maximum_age":15,"healthy_volunteers":45,"eligibility_criteria":46,"std_ages":50,"locations":53,"central_contacts":69,"overall_officials":72,"references":73,"see_also_links":74},"NCT07638943","GSNVI-INFUSETODT1","Refitting Satisfied INFUSE One-Day Multifocal Wearers to DAILIES TOTAL1 Multifocal Contact Lenses","Clinical Outcomes Following Refit From INFUSE One-Day Multifocal to DAILIES TOTAL1 Multifocal in Satisfied Presbyopic Wearers: A Prospective, Open-Label, Single-Arm Study","RECRUITING","2027-02-28","2026-06","2026-06-11","2026-05-20","Gordon Schanzlin New Vision","OTHER",null,"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","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.",[19,20],"Contact Lens Comfort and Successful Refitting","Presbyopia",[22],"contact lenses","INTERVENTIONAL","TREATMENT",[26],"NA",{"count":28,"type":29},30,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"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\u002Fday, at least 5 days\u002Fweek 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.",[36],"DAILIES TOTAL1 Multifocal",[38],{"measure":39,"description":40,"timeFrame":41},"Proportion of participants with Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score \u003C12","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.\n\nThe primary endpoint is the proportion of participants achieving a CLDEQ-8 score \\\u003C12 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)",[],"ALL","40 Years",true,{"inclusion":47,"exclusion":48,"raw_text":49},[],[],"Inclusion Criteria:\n\nAge ≥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 \\\u003C12 at baseline Minimum contact lens wear of ≥8 hours\u002Fday, ≥5 days\u002Fweek, for ≥30 days prior to Visit 1 Best-corrected distance visual acuity ≥20\u002F25 (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\u002Fday, ≥5 days\u002Fweek and complete all study questionnaires Able to provide written informed consent and comply with investigator instructions\n\nExclusion Criteria:\n\nActive 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\u002FIndustry scale) Current monovision or modified monovision contact lens wear Pregnant or lactating participants Participation in another clinical trial within 30 days prior to enrollment",[51,52],"ADULT","OLDER_ADULT",[54],{"facility":55,"status":8,"city":56,"state":57,"zip":58,"country":59,"contacts":60,"geoPoint":66},"Gordon Schanzlin New Vision Institute","La Jolla","California","92037","United States",[61],{"name":62,"role":63,"phone":64,"email":65},"David Geffen, OD, FAAO","CONTACT","858-455-6800","dgeffen@gwsvision.com",{"lat":67,"lon":68},32.84727,-117.2742,[70],{"name":62,"role":63,"phone":71,"email":65},"8584556800",[],[],[],{"nct_id":4,"conditions":76,"biomarkers":77},[20],[],{"nct_id":4,"found":79,"summary":15,"prompt_version":15},false]