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

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

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.

Study Overview

• Status: Completed
• Conditions: Photorefractive Keratectomy
• Intervention / Treatment: Drug: nepafenac 0.1%; Other: ketorolac 0.4%

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78236
      • Lackland Air Force base

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Subjective pain	Day 5

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of epithelial healing	Time to event

Collaborators and Investigators

• Sponsor: Alcon Research
• Collaborators: Matthew Caldwell
• Investigators: Principal Investigator: Matthew Caldwell

Publications and helpful links

General Publications

• Caldwell M, Reilly C. Effects of topical nepafenac on corneal epithelial healing time and postoperative pain after PRK: a bilateral, prospective, randomized, masked trial. J Refract Surg. 2008 Apr;24(4):377-82. doi: 10.3928/1081597X-20080401-11.

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (Actual): June 1, 2006
• Study Completion (Actual): June 1, 2006

Study Registration Dates

• First Submitted: May 25, 2006
• First Submitted That Met QC Criteria: May 25, 2006
• First Posted (Estimate): May 29, 2006

Study Record Updates

• Last Update Posted (Estimate): November 18, 2016
• Last Update Submitted That Met QC Criteria: November 17, 2016
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Photorefractive Keratectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ketorolac; Nepafenac
• Other Study ID Numbers: FWH20060020H