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A Comparison of Topical Nepafenac to Placebo in Corneal Epithelial Healing Times and Postoperative Pain Relief

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ClinicalTrials.gov Identifier: NCT00330798
Recruitment Status : Completed
First Posted : May 29, 2006
Last Update Posted : November 18, 2016
Sponsor:
Collaborator:
Matthew Caldwell
Information provided by (Responsible Party):
Alcon Research

Study Description
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Brief Summary:
The purpose of this study is to compare healing times and subjective pain level responses of nepafenac to placebo after photo refractive keratomileusis (PRK) surgery.

Condition or disease Intervention/treatment Phase
Photorefractive Keratectomy Drug: nepafenac 0.1% Other: ketorolac 0.4% Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Comparison of Topical Nepafenac to Placebo in Corneal Epithelial Healing Times and Postoperative Pain Relief of Patients Status Post-Photorefractive Keratectomy: A Double-Masked Randomized Prospective Study
Study Start Date : February 2006
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Nevanac
One drop, three times daily, in the assigned eye for the first three postoperative days
 Drug: nepafenac 0.1%
Nepafenac 0.1% randomly assigned to one eye, with ketorolac 0.4% in the fellow eye for contralateral post-surgical use.
Placebo Comparator: Acular LS
One drop, three times daily, in the assigned eye for the first three postoperative days
 Other: ketorolac 0.4%
Keterolac 0.4% randomly assigned to one eye, with nepafenac 0.1% in the fellow eye for contralateral post-surgical use.


Outcome Measures
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Primary Outcome Measures :
  1. Subjective pain [ Time Frame: Day 5 ]

Secondary Outcome Measures :
  1. Rate of epithelial healing [ Time Frame: Time to event ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 19 years or older with healthy ocular status and pre-operative refractive anisometropia of less than 2.000 diopters between eyes undergoing bilateral PRK surgery.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Those desiring PRK in only one eye, those in need of additional topical eye medications, those with history of drug/alcohol abuse, women breastfeeding or pregnant.
  • Other protocol-defined exclusion criteria may apply.
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): NCT00330798


Locations
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United States, Texas
Lackland Air Force Base
San Antonio, Texas, United States, 78236
Sponsors and Collaborators
Alcon Research
Matthew Caldwell
Investigators
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Principal Investigator: Matthew Caldwell
More Information
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Publications of Results:

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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00330798    
Other Study ID Numbers: FWH20060020H
First Posted: May 29, 2006    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: May 2012
Keywords provided by Alcon Research:
Photorefractive Keratectomy
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
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