Comparison of Acular LS Versus Nevanac for Pain Control in Eyes Undergoing PRK
Primary Purpose
Myopia, Hyperopia
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
ketorolac (Acular LS)
Nepafenac (Nevanac)
Sponsored by
About this trial
This is an interventional treatment trial for Myopia focused on measuring PRK, laser vision correction, surface ablation, pain, wound healing, corneal haze
Eligibility Criteria
Inclusion Criteria: Patients undergoing PRK for myopia or hyperopia Exclusion Criteria: -
Sites / Locations
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00347204
First Posted
June 29, 2006
Last Updated
June 29, 2006
Sponsor
Center For Excellence In Eye Care
Collaborators
Allergan
1. Study Identification
Unique Protocol Identification Number
NCT00347204
Brief Title
Comparison of Acular LS Versus Nevanac for Pain Control in Eyes Undergoing PRK
Official Title
Double Masked Evaluation of Acular LS Versus Nevanac for Postoperative Pain Control in Eyes Undergoing PRK
Study Type
Interventional
2. Study Status
Record Verification Date
June 2006
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Center For Excellence In Eye Care
Collaborators
Allergan
4. Oversight
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Hyperopia
Keywords
PRK, laser vision correction, surface ablation, pain, wound healing, corneal haze
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ketorolac (Acular LS)
Intervention Type
Drug
Intervention Name(s)
Nepafenac (Nevanac)
Primary Outcome Measure Information:
Title
Prevention of postoperative discomfort on postoperative days 1 to 5 after PRK
Title
Best-corrected Visual acuity at all study visits
Title
Degree of corneal haze at all study visits
Title
Time to epithelial closure in each eye after PRK
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients undergoing PRK for myopia or hyperopia
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Trattler, MD
Organizational Affiliation
Center For Excellence In Eye Care
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Comparison of Acular LS Versus Nevanac for Pain Control in Eyes Undergoing PRK
We'll reach out to this number within 24 hrs