Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-03-12 @ 6:38 AM
Study NCT ID:
NCT02185105
Status:
COMPLETED
Last Update Posted:
2017-03-07
First Post:
2014-07-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Validation of Biofinity Toric MTO (Made To Order) Lenses
Sponsor:
CooperVision, Inc.
Organization:
Study Overview
Official Title:
Clinical Validation of Biofinity Toric MTO (Made To Order) Lenses
Status:
COMPLETED
Status Verified Date:
2017-01
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 study hypothesis is there is no difference in the clinical performance between the test and control lenses, in particular in lens stability, toric mislocation, comfort ratings and anterior segment ocular health findings.
Detailed Description:
Evaluate the clinical performance of Biofinity toric MTO lenses against current commercial Biofinity toric lenses over 6 hours of lens wear.
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?: