Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT00781092
Status:
COMPLETED
Last Update Posted:
2012-09-20
First Post:
2008-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective, Randomized, Double-Masked, Single Center, Clinical Comparison of the Use of Systane Ultra in the Management of Dry Eyes in Bilateral Eyes
Sponsor:
Durrie Vision
Organization:
Study Overview
Official Title:
A Prospective, Randomized, Double-Masked, Single Center, Clinical Comparison of the Use of Systane Ultra in the Management of Dry Eyes in Bilateral Eyes
Status:
COMPLETED
Status Verified Date:
2012-09
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:
The primary objective of this study is to compare two post operative drop regimens for the management of dry eye and control of healing using FDA-approved ophthalmic solutions.
Detailed Description:
This comparison will be made between bilateral eyes of the same patient following excimer laser ablation using the FDA-approved LADARVision 4000 Excimer Laser System or the WaveLight ALLEGRETTO WAVE™ Excimer Laser System. Post operative questionnaires regarding the use of the drops will be compared. Tear osmolarity and tear breakup time will be evaluated using Tear Lab and OQAS II.
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?: