Refitting Satisfied INFUSE One-Day Multifocal Wearers to DAILIES TOTAL1 Multifocal Contact Lenses
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorGordon Schanzlin New Vision
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
DAILIES TOTAL1 Multifocal (delefilcon A)
DeviceDaily 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: DAILIES TOTAL1 MultifocalExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
2 weeks after wearing finalized DAILIES TOTAL1 Multifocal prescription (Visit 3, ~Day 21)Sponsors and contacts
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Gordon Schanzlin New Vision
Lead sponsor
Alcon Research
Collaborator
Source ClinicalTrials.gov