Ignite Creation Date:
2024-07-17 @ 10:48 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06462456
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-17
First Post:
2024-06-12
Brief Title:
Post-market Clinical Follow-up Study of Alcon PRECISION1 Spherical and PRECISION1 for Astigmatism Soft Contact Lenses
Sponsor:
Alcon Research
Organization:
Alcon Research
Study Overview
Official Title:
Post-market Clinical Follow-up Study of Alcon PRECISION1 Spherical Soft Contact Lenses Verofilcon A and PRECISION1T for Astigmatism Contact Lenses Verofilcon A
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess long term performance and safety of verofilcon A soft contact lenses in a real-world setting in a population of 7 years or older having at least 1 year of verofilcon A sphere or toric contact lens wear in a daily wear and daily disposable modality
Detailed Description:
This study consists of a Baseline Visit and a Year 1 Visit
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 PRECISION1 sphere or toric contact lens prescription was released The Baseline Visit will be retrospective with all assessments obtained from chart review
The Year 1 Visit is defined as the visit that occurs 1 year -24 months since Baseline during which period the subject is wearing test lenses of the same design in both eyes and a contact lens examination is performed during the visit The Year 1 Visit may be prospective or retrospective
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 PRECISION1 sphere or toric contact lens prescription was released The Baseline Visit will be retrospective with all assessments obtained from chart review
The Year 1 Visit is defined as the visit that occurs 1 year -24 months since Baseline during which period the subject is wearing test lenses of the same design in both eyes and a contact lens examination is performed during the visit The Year 1 Visit may be prospective or retrospective
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None