Comparison of Acular LS Versus Nevanac for Pain Control in Eyes Undergoing PRK

Sponsor

Center For Excellence In Eye Care (Other)

Overall Status

Completed

CT.gov ID

NCT00347204

Collaborator

Allergan (Industry)

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

To determine the ability of two topical Nonsteroidal Anti-inflammatory drops (Acular LS & Nevanac) to help control pain following Photorefractive Keratectomy (PRK).

Condition or Disease	Intervention/Treatment	Phase
Myopia Hyperopia	Drug: ketorolac (Acular LS) Drug: Nepafenac (Nevanac)	Phase 4

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-LASIK.1 With surface laser procedures, the corneal epithelium is removed by a variety of techniques (laser, manual debridement, diluted alcohol2,3, 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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Double Masked Evaluation of Acular LS Versus Nevanac for Postoperative Pain Control in Eyes Undergoing PRK

Study Start Date :

Jan 1, 2006

Study Completion Date :

Jun 1, 2006

Outcome Measures

Primary Outcome Measures

Prevention of postoperative discomfort on postoperative days 1 to 5 after PRK []
Best-corrected Visual acuity at all study visits []
Degree of corneal haze at all study visits []
Time to epithelial closure in each eye after PRK []