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

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by:
Center For Excellence In Eye Care
ClinicalTrials.gov Identifier:
NCT00347204
First received: June 29, 2006
Last updated: NA
Last verified: June 2006
History: No changes posted

June 29, 2006
June 29, 2006
January 2006
Not Provided
  • 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
Same as current
No Changes Posted
Not Provided
Not Provided
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Not Provided
 
Comparison of Acular LS Versus Nevanac for Pain Control in Eyes Undergoing PRK
Double Masked Evaluation of Acular LS Versus Nevanac for Postoperative Pain Control in Eyes Undergoing PRK

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Myopia
  • Hyperopia
  • Drug: ketorolac (Acular LS)
  • Drug: Nepafenac (Nevanac)
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2006
Not Provided

Inclusion Criteria:

  • Patients undergoing PRK for myopia or hyperopia

Exclusion Criteria:

-

Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00347204
5225
Not Provided
Not Provided
Center For Excellence In Eye Care
Allergan
Principal Investigator: William Trattler, MD Center For Excellence In Eye Care
Center For Excellence In Eye Care
June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP