Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
36 participants
OBSERVATIONAL
2026-01-21
2027-01-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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TOTAL30 Multifocal
TOTAL30 Multifocal
Eligibility Criteria
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Inclusion Criteria
* Subjects who currently wear soft multi-focal contact lenses and score \<12 on an entering CLDEQ-8 survey.
* Subjects who are \>= 40 years old.
* Subjects who can and are willing to wear their lenses for 13 hours per day during the study period, and 16 hours per day when questionnaires are being taken.
* Willing to insert their contact lenses between 6:00 am and 8:00 am on the days when questionnaires will be taken.
* Vision correctable in soft multi-focal contact lenses to 20/25 (0.10 log MAR) or better in each eye at 6M.
* Must be able to be successfully fit into the prescription parameters available for Total30 MF contact lenses.
* Required to have a smartphone and receive push notifications.
* Willing to attend all study visits.
* Willing to be diligent about answering the timed surveys in a prompt manner.
Exclusion Criteria
* Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator.
* Use of isotretinoin-derivatives.
* Use of lubricating drops.
* Monocular patients or patients fit with only 1 multifocal lens.
* Prior refractive surgery.
* History of herpetic keratitis, ocular surgery, or irregular cornea.
* Pregnant or lactating.
* Having participated in a clinical trial in the past 30 days.
* High-ADD habitual wearers using a different fitting approach than Alcon's multifocal fitting guide (e.g., J\&J or CooperVision's fitting guide adopting a modified monovision approach).
* Are past rigid CL wearers.
* Have a history of being diagnosed with dry eye or ocular allergies.
* Have history of severe ocular trauma.
40 Years
ALL
No
Sponsors
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Sengi
INDUSTRY
Scripps Poway Eyecare and Optometry
OTHER
Responsible Party
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Principal Investigators
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Jay Mashouf, OD
Role: PRINCIPAL_INVESTIGATOR
Scripps Optometric Group
Locations
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Scripps Optometric Group
San Diego, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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JM-25-02
Identifier Type: -
Identifier Source: org_study_id