Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00344643
Status:
COMPLETED
Last Update Posted:
2008-06-23
First Post:
2006-06-23
Brief Title:
A Comparison of 12 Month Daily Wear of Two Novel O2 Permeable Silicone Hydrogel CLs HOPSiH and A Control Standard O2 Lens
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
A Comparison of 12 Month Daily Wear of Two Novel Hyper-Oxygen Permeable Silicone Hydrogel Contact Lenses HOPSiH and A Control Standard Oxygen Permeable Lens and 30-Night Versus 6-Night Immediate Extended Wear of Two HOPSiH Lenses
Status:
COMPLETED
Status Verified Date:
2008-06
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 purpose of this research is to compare the on-eye performance of 12 month daily wear versus 6-night extended wear and 30-night extended wear of novel hyper-oxygen permeable contact lenses by studying its effects on human eyes Usual and customary care will be given in the form of eyeglasses andor contact lenses
Detailed Description:
The purpose of this research is to compare the on-eye performance of 12 month daily wear versus 6-night extended wear and 30-night extended wear of novel hyper-oxygen permeable contact lenses on bacterial binding to corneal cells and central epithelial thickness Usual and customary care will be given in the form of eyeglasses and contact lenses To compare long-term Daily wear vs immediate Overnight wear Extended wear of a new hyper-oxygen permeable silicone hydrogel contact lens on binding of Pseudomonas Aeruginosa to exfoliated human surface corneal cells collected from the eyes of human patients and on central corneal thickness as follows 1 a hyper Dkt lens for 12 months of daily wear 2 a hyper Dkt lens for 12 months of de novo 6 night extended wear and 3 a hyper Dkt lens for 12 months of de novo 30 night extended wear
Study Oversight
Has Oversight DMC:
None
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?:
None