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

Primary Purpose

Myopia, Hyperopia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
ketorolac (Acular LS)
Nepafenac (Nevanac)
Sponsored by
Center For Excellence In Eye Care
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring PRK, laser vision correction, surface ablation, pain, wound healing, corneal haze

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients undergoing PRK for myopia or hyperopia Exclusion Criteria: -

Sites / Locations

    Outcomes

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    June 29, 2006
    Last Updated
    June 29, 2006
    Sponsor
    Center For Excellence In Eye Care
    Collaborators
    Allergan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00347204
    Brief Title
    Comparison of Acular LS Versus Nevanac for Pain Control in Eyes Undergoing PRK
    Official Title
    Double Masked Evaluation of Acular LS Versus Nevanac for Postoperative Pain Control in Eyes Undergoing PRK
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2006 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 2006 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Center For Excellence In Eye Care
    Collaborators
    Allergan

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopia, Hyperopia
    Keywords
    PRK, laser vision correction, surface ablation, pain, wound healing, corneal haze

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    40 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    ketorolac (Acular LS)
    Intervention Type
    Drug
    Intervention Name(s)
    Nepafenac (Nevanac)
    Primary Outcome Measure Information:
    Title
    Prevention of postoperative discomfort on postoperative days 1 to 5 after PRK
    Title
    Best-corrected Visual acuity at all study visits
    Title
    Degree of corneal haze at all study visits
    Title
    Time to epithelial closure in each eye after PRK

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients undergoing PRK for myopia or hyperopia Exclusion Criteria: -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    William Trattler, MD
    Organizational Affiliation
    Center For Excellence In Eye Care
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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