Ignite Creation Date:
2025-12-24 @ 6:34 PM
Ignite Modification Date:
2026-01-02 @ 3:00 AM
Study NCT ID:
NCT03417557
Status:
COMPLETED
Last Update Posted:
2020-05-04
First Post:
2018-01-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Validation Study of Comfilcon A Multifocal Toric Contact Lenses
Sponsor:
CooperVision, Inc.
Organization:
Study Overview
Official Title:
Clinical Validation Study of Biofinity Multifocal Toric Contact Lenses
Status:
COMPLETED
Status Verified Date:
2020-04
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 is a study to evaluate the clinical performance and subjective acceptance of an investigational contact lens (test), compared to a marketed lens (control) in an in-office setting.
Detailed Description:
This is a study to evaluate the clinical performance (including visual acuity, subjective assessments of visual performance, comfort ratings, vision preference and lens fit) of a comfilcon A investigational contact lens (test) compared to a control contact lens, in a non-dispensing setting. The main study hypothesis is the test contact lens will not be clinically inferior to the control lens.
Study Oversight
Has Oversight DMC:
False
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?: