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

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

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, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

Center For Excellence In Eye Care

Allergan

Investigators

Principal Investigator:	William Trattler, MD	Center For Excellence In Eye Care

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00347204 History of Changes
Obsolete Identifiers:	NCT00405028
Other Study ID Numbers:	5225
First Posted:	July 4, 2006
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:

Hyperopia; Refractive Errors; Eye Diseases; Ketorolac; Nepafenac; Ketorolac Tromethamine; 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