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

This study has been completed.
Sponsor:
Collaborator:
Matthew Caldwell
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00330798
First received: May 25, 2006
Last updated: May 22, 2012
Last verified: May 2012
  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-Blind
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of epithelial healing [ Time Frame: Time to event ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00330798     History of Changes
Other Study ID Numbers: FWH20060020H
Study First Received: May 25, 2006
Last Updated: May 22, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Photorefractive Keratectomy

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 22, 2014