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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00330798
First Posted: May 29, 2006
Last Update Posted: November 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Matthew Caldwell
Information provided by (Responsible Party):
Alcon Research
  Purpose
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 Intervention Phase
Photorefractive Keratectomy Drug: nepafenac 0.1% Other: ketorolac 0.4% Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

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

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

Enrollment: 40
Study Start Date: February 2006
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

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

Publications:
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00330798     History of Changes
Other Study ID Numbers: FWH20060020H
First Submitted: May 25, 2006
First Posted: May 29, 2006
Last Update Posted: November 18, 2016
Last Verified: May 2012

Keywords provided by Alcon Research:
Photorefractive Keratectomy

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Ketorolac
Ketorolac Tromethamine
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