Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-02-21 @ 2:55 PM
Study NCT ID:
NCT02637804
Status:
COMPLETED
Last Update Posted:
2017-10-23
First Post:
2015-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Daily Disposable Silicone Hydrogel Contact Lens, Stenfilcon A, Clinical Study
Sponsor:
CooperVision, Inc.
Organization:
Study Overview
Official Title:
Daily Disposable Silicone Hydrogel Contact Lens, Stenfilcon A, Clinical Study
Status:
COMPLETED
Status Verified Date:
2017-09
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:
Clinical evaluation of stenfilcon A compared with narafilcon A and delefilcon A
This is a total 120 subject, randomized, open label, bilateral wear, two week crossover study (each lens for 1 week) evaluating the clinical performance of stenfilcon A spherical lenses compared to narafilcon A or delefilcon A spherical lenses.
This is a total 120 subject, randomized, open label, bilateral wear, two week crossover study (each lens for 1 week) evaluating the clinical performance of stenfilcon A spherical lenses compared to narafilcon A or delefilcon A spherical lenses.
Detailed Description:
The aim of this study is to evaluate the clinical performance of stenfilcon A compared with narafilcon A and delefilcon A.
The study participants will be allocated to two parallel groups (Group 1 and Group 2), 60 subjects each, based on the control lenses, narafilcon A and delefilcon A spherical lenses.
Study groups:
Group 1: stenfilcon A vs. narafilcon A
Group 2: stenfilcon A vs. delefilcon A
The study participants will be allocated to two parallel groups (Group 1 and Group 2), 60 subjects each, based on the control lenses, narafilcon A and delefilcon A spherical lenses.
Study groups:
Group 1: stenfilcon A vs. narafilcon A
Group 2: stenfilcon A vs. delefilcon A
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?: