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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00347204
• Other study ID #: 5225
• Status: Completed
• Phase: Phase 4
• First received: June 29, 2006
• Last updated: June 29, 2006
• Start date: January 2006
• Est. completion date: June 2006

Study information

• Verified date: June 2006
• Source: Center For Excellence In Eye Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Other known NCT identifiers

• NCT00405028

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients undergoing PRK for myopia or hyperopia

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperopia
• Myopia

Intervention

Drug:
• ketorolac (Acular LS)

• Nepafenac (Nevanac)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Center For Excellence In Eye Care	Allergan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevention of postoperative discomfort on postoperative days 1 to 5 after PRK
Primary	Best-corrected Visual acuity at all study visits
Primary	Degree of corneal haze at all study visits
Primary	Time to epithelial closure in each eye after PRK