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
  Purpose

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


Condition Intervention Phase
Myopia
Hyperopia
Drug: ketorolac (Acular LS)
Drug: Nepafenac (Nevanac)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Double Masked Evaluation of Acular LS Versus Nevanac for Postoperative Pain Control in Eyes Undergoing PRK

Resource links provided by NLM:


Further study details as provided by Center For Excellence In Eye Care:

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

Estimated Enrollment: 40
Study Start Date: January 2006
Estimated Study Completion Date: June 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients undergoing PRK for myopia or hyperopia

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00347204

Sponsors and Collaborators
Center For Excellence In Eye Care
Allergan
Investigators
Principal Investigator: William Trattler, MD Center For Excellence In Eye Care
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00347204     History of Changes
Obsolete Identifiers: NCT00405028
Other Study ID Numbers: 5225
Study First Received: June 29, 2006
Last Updated: June 29, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Center For Excellence In Eye Care:
PRK
laser vision correction
surface ablation
pain
wound healing
corneal haze

Additional relevant MeSH terms:
Hyperopia
Myopia
Refractive Errors
Eye Diseases
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 24, 2014