Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06408649
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-05-07
Brief Title:
Post-market Clinical Follow-up Study of Alcon TOTAL30 Contact Lenses Lehfilcon A
Sponsor:
Alcon Research
Organization:
Alcon Research
Study Overview
Official Title:
Post-market Clinical Follow-up Study of Alcon TOTAL30 Spherical Contact Lenses Lehfilcon A and TOTAL30 for Astigmatism Contact Lenses Lehfilcon A
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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 Post-Market Clinical Follow-Up PMCF study is to continuously assess the visual performance and safety of TOTAL30 Sphere and TOTAL30 for Astigmatism contact lenses in a real-world setting across a broad variety of patients through routine clinical practices
Detailed Description:
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 TOTAL30 sphere or toric contact lens prescription was released Baseline visit data will be collected retrospectively chart review
The Year 1 visit is defined as the visit that occurs 1 year -26 months since the Baseline visit during which period the subject is wearing test lenses of the same design in both eyes and a contact lens examination is performed Year 1 data will be collected either retrospectively or prospectively eye exam
The Year 1 visit is defined as the visit that occurs 1 year -26 months since the Baseline visit during which period the subject is wearing test lenses of the same design in both eyes and a contact lens examination is performed Year 1 data will be collected either retrospectively or prospectively eye exam
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