Ignite Creation Date:
2024-07-17 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06483113
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-26
Brief Title:
DAILIES TOTAL1 Soft Contact Lenses - Post-Market Clinical Follow-up Study
Sponsor:
Alcon Research
Organization:
Alcon Research
Study Overview
Official Title:
DAILIES TOTAL1 Soft Contact Lenses - Post-Market Clinical Follow-up Study
Status:
NOT_YET_RECRUITING
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 continuously assess the visual performance and safety of DAILIES TOTAL1 soft contact lenses in a real world setting and broader patient base through routine clinical practices This activity will be used to continuously support delefilcon A sphere toric and multifocal soft contact lens regulatory requirements and standards
Detailed Description:
This study includes 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 DAILIES TOTAL1 sphere toric or multifocal soft contact lens prescription was released The Baseline visit will be retrospective All assessments at baseline will be obtained from chart reviews
The Year 1 visit is defined as the visit that occurs 1 year -24 months since the Baseline visit during which period the subject is wearing prescribed lenses and a contact lens examination is performed The Year 1 visit can be either retrospective or prospective in subjects 7 to less than 18 years of age For subjects 18 years of age and older the Year 1 visit will be 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 DAILIES TOTAL1 sphere toric or multifocal soft contact lens prescription was released The Baseline visit will be retrospective All assessments at baseline will be obtained from chart reviews
The Year 1 visit is defined as the visit that occurs 1 year -24 months since the Baseline visit during which period the subject is wearing prescribed lenses and a contact lens examination is performed The Year 1 visit can be either retrospective or prospective in subjects 7 to less than 18 years of age For subjects 18 years of age and older the Year 1 visit will be 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