Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-01-23 @ 4:29 AM
Study NCT ID:
NCT02248766
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2014-09-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Performance of Habitual Wearers of Avaira Toric When Refitted With Clariti Toric Lenses
Sponsor:
CooperVision, Inc.
Organization:
Study Overview
Official Title:
Clinical Performance of Habitual Wearers of Avaira Toric (Enfilcon A) When Refitted With Clariti Toric (Somofilcon A) Lenses for 1 Month.
Status:
COMPLETED
Status Verified Date:
2020-07
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 aim of this dispensing study is to evaluate the clinical performance of existing wearers of Avaira toric lenses following a refit with Clariti toric over 1 month of daily wear.
Detailed Description:
This is a 30-subject, prospective dispensing study comparing the clinical performance of the subjects' habitual Avaira toric lenses following a refit with Clariti toric lenses. Subject's habitual Avaira toric lenses will be evaluated at the first visit and then re-fitted with a pair of Clariti toric lenses for 1 month of daily wear. After the dispensing visit, subjects will return for evaluations at 1 week, 2 weeks and 4 weeks.
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?: