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

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ClinicalTrials.gov Identifier: NCT00347204
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : July 4, 2006
Sponsor:
Collaborator:
Allergan
Information provided by:
Center For Excellence In Eye Care

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
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 : January 2006
Study Completion Date : June 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Prevention of postoperative discomfort on postoperative days 1 to 5 after PRK
  2. Best-corrected Visual acuity at all study visits
  3. Degree of corneal haze at all study visits
  4. Time to epithelial closure in each eye after PRK

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients undergoing PRK for myopia or hyperopia

Exclusion Criteria:

-

Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00347204


Sponsors and Collaborators
Center For Excellence In Eye Care
Allergan
Investigators
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Principal Investigator: William Trattler, MD Center For Excellence In Eye Care
More Information
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ClinicalTrials.gov Identifier: NCT00347204    
Obsolete Identifiers: NCT00405028
Other Study ID Numbers: 5225
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: July 4, 2006
Last Verified: June 2006
Keywords provided by Center For Excellence In Eye Care:
PRK
laser vision correction
surface ablation
 pain
wound healing
corneal haze
Additional relevant MeSH terms:
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Hyperopia
Refractive Errors
Eye Diseases
Ketorolac
Nepafenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action