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The purpose of this Post-Market Clinical Follow-Up (PMCF) study is to assess long term performance and safety of Air Optix plus HydraGlyde Multifocal soft contact lenses in a real-world setting when worn as daily wear or extended (overnight) wear.
This is a non-interventional/observational study designed as a retrospective chart review. Study sites will identify charts within their existing databases in a fair and consistent manner, e.g., reviewing all eligible charts in reverse chronological order by year of baseline visit. The baseline visit will be defined as the first office visit where an eye care practitioner provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for the study or comparator contact lenses was released. Subjects/charts meeting the eligibility criteria will be enrolled in the study.
Age
40 - No limit years
Sex
ALL
Healthy Volunteers
No
Complete Family Vision Care
San Diego, California, United States
Pearle Vision
Jacksonville, Florida, United States
Jackson Health Community Center
Miami, Florida, United States
Vision Health Institute
Orlando, Florida, United States
Complete Eye Care of Medina
Medina, Minnesota, United States
Koetting Associates
St Louis, Missouri, United States
Sacco Eye Group
Vestal, New York, United States
Smith Bowman Ophthalmology
Salt Lake City, Utah, United States
Start Date
August 8, 2023
Primary Completion Date
June 20, 2025
Completion Date
June 20, 2025
Last Updated
August 14, 2025
351
ACTUAL participants
Lotrafilcon B multifocal soft contact lenses
DEVICE
Comfilcon A multifocal soft contact lenses
DEVICE
Lead Sponsor
Alcon Research
NCT05458323
NCT06996353
NCT04077086
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
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