Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-02-19 @ 4:32 AM
Study NCT ID:
NCT02553395
Status:
COMPLETED
Last Update Posted:
2020-12-22
First Post:
2015-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
One Week Assessment of The Phenacite Lens
Sponsor:
CooperVision, Inc.
Organization:
Study Overview
Official Title:
One Week Assessment of The Phenacite Lens
Status:
COMPLETED
Status Verified Date:
2020-11
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:
This study will investigate performance criteria over one week of daily wear to determine if the Study Test contact lens performs equivalently to the comfilcon A contact lenses in terms of subjective ratings and of visual performance.
The study test lens was not the final optical design and the study results were not used for the design validation.
The study test lens was not the final optical design and the study results were not used for the design validation.
Detailed Description:
This will be double-masked, randomized, bilateral crossover study comparing the Study Test lens against the comfilcon A control lens, each worn over one week of daily wear.
The study test lens was not the final optical design and the study results were not used for the design validation.
The study test lens was not the final optical design and the study results were not used for the design validation.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: