Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00347204
Status:
COMPLETED
Last Update Posted:
2006-07-04
First Post:
2006-06-29
Brief Title:
Comparison of Acular LS Versus Nevanac for Pain Control in Eyes Undergoing PRK
Sponsor:
Center For Excellence In Eye Care
Organization:
Center For Excellence In Eye Care
Study Overview
Official Title:
Double Masked Evaluation of Acular LS Versus Nevanac for Postoperative Pain Control in Eyes Undergoing PRK
Status:
COMPLETED
Status Verified Date:
2006-06
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:
To determine the ability of two topical Nonsteroidal Anti-inflammatory drops Acular LS Nevanac to help control pain following Photorefractive Keratectomy PRK
Detailed Description:
Laser Vision Correction is the most commonly performed elective surgical procedure in the United States Although Laser-Assisted in-situ Keratomileusis LASIK is the more popular technique a growing number of surgeons have switched to surface ablation techniques including PRK LASEK and Epi-LASIK1 With surface laser procedures the corneal epithelium is removed by a variety of techniques laser manual debridement diluted alcohol23 epi-keatome prior to laser reshaping of the corneal stroma Following the procedure a contact lens is placed on the eye to promote epithelial regeneration Due to the size of the epithelial defect it can take between 3 to 6 days for the epithelium to regenerate During this healing process patients often complain of moderate to severe ocular pain and delayed healing may result in an increased risk of infection or corneal haze4
Over the past decade a variety of methods have been used to assist with reducing pain following surface laser procedures Topical Nonsteroidals have been shown in a number of studies to help reduce the degree of pain following PRK Topical dilute tetracaine has also been shown to assist with the reduction of pain following PRK Oral pain medications such as Vioxx Celebrex and even Prednisone have been recommended as additional treatment options for pain control
In October 2005 a new topical nonsteroidal anti-inflammatory drop Nevanac was approved by the FDA Nevanac was approved with a a TID dosing schedule
Acular LS is the current market leader for topical NSAID eye drops Acular LS is typically used on a QID dosing schedule
Over the past decade a variety of methods have been used to assist with reducing pain following surface laser procedures Topical Nonsteroidals have been shown in a number of studies to help reduce the degree of pain following PRK Topical dilute tetracaine has also been shown to assist with the reduction of pain following PRK Oral pain medications such as Vioxx Celebrex and even Prednisone have been recommended as additional treatment options for pain control
In October 2005 a new topical nonsteroidal anti-inflammatory drop Nevanac was approved by the FDA Nevanac was approved with a a TID dosing schedule
Acular LS is the current market leader for topical NSAID eye drops Acular LS is typically used on a QID dosing schedule
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