Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-27 @ 11:06 PM
Study NCT ID:
NCT04226560
Status:
UNKNOWN
Last Update Posted:
2021-02-24
First Post:
2020-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Performance and Safety of Silicone Hydrogel Soft Contact Lenses
Sponsor:
ApexLens Co., Ltd.
Organization:
Study Overview
Official Title:
Clinical Evaluation of the Clinical Performance and Safety of a New Monthly Disposable Silicone Hydrogel Soft Contact Lenses
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
RECRUITING
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:
To demonstrate substantial equivalence of the new Silicone Hydrogel Soft Contact Lenses(SHSCL) to the commercially available ACUVUE® VITA™ contact lens
Detailed Description:
This study is a prospective, subject-masked, bilateral, randomized, parallel group dispensing study comparing the SHSCL test lens against the 1-Month ACUVUE® VITA™ (1-MAV) control lenses. Each subject will be randomized to wear either the test or of the control with similar/comparable lens parameters optimized for vision.
Both test and control lens will be used in their daily wear, monthly replacement modality for thirteen (13) weeks. It is anticipated that this study will involve up to 6 scheduled visits.
Both test and control lens will be used in their daily wear, monthly replacement modality for thirteen (13) weeks. It is anticipated that this study will involve up to 6 scheduled visits.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: