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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2006-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Myopia Hyperopia

Keywords

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PRK laser vision correction surface ablation pain wound healing corneal haze

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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ketorolac (Acular LS)

Intervention Type DRUG

Nepafenac (Nevanac)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing PRK for myopia or hyperopia

Exclusion Criteria

\-

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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William Trattler, MD

Role: PRINCIPAL_INVESTIGATOR

Center For Excellence In Eye Care

Other Identifiers

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5225

Identifier Type: -

Identifier Source: org_study_id

NCT00405028