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The purpose of this retrospective, Post-Market Clinical Follow-Up (PMCF) study is to assess the long term performance and safety of Air Optix® Night and Day® Aqua (AONDA) contact lenses in a real-world setting when worn as 30 days of continuous wear for vision correction.
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. Subjects/charts meeting the eligibility criteria will be enrolled in the study. The study is designed with one period. The duration of the period includes the Baseline Visit and the Year 3 Visit as follows: * The Baseline Visit is defined as the first office visit where an eye care professional provided an in-person office biomicroscopy exam to the subject, before or during which a contact lens prescription for AONDA or PureVision 2 (PV2) was released. * The Year 3 Visit is defined as a visit which occurred 3 years (-2/+8 months) since Baseline during which period the subject was wearing AONDA contact lenses or PV2 contact lenses and a contact lens examination was performed. The data collection period is defined as any approximately 3-year timeframe since and including 2009.
Age
18 - 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
October 5, 2023
Primary Completion Date
August 22, 2024
Completion Date
August 22, 2024
Last Updated
September 19, 2024
1,256
ACTUAL participants
Lotrafilcon A contact lenses
DEVICE
Balafilcon A 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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