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

Sponsor

Alcon Research (Industry)

Overall Status

Completed

CT.gov ID

NCT00330798

Collaborator

Matthew Caldwell (Other)

Enrollment

Location

Arms

3.9

Duration (Months)

10.1

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Feb 1, 2006

Actual Primary Completion Date :

Jun 1, 2006

Actual Study Completion Date :

Jun 1, 2006

Arms and Interventions

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.

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

Primary Outcome Measures

Subjective pain [Day 5]

Secondary Outcome Measures

Rate of epithelial healing [Time to event]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Lackland Air Force Base	San Antonio	Texas	United States	78236

Sponsors and Collaborators

Alcon Research
Matthew Caldwell

Investigators

Principal Investigator: Matthew Caldwell,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alcon Research

ClinicalTrials.gov Identifier:

NCT00330798

Other Study ID Numbers:

FWH20060020H

First Posted:

May 29, 2006

Last Update Posted:

Nov 18, 2016

Last Verified:

May 1, 2012

Keywords provided by Alcon Research

Photorefractive Keratectomy

Additional relevant MeSH terms:

Pain, Postoperative

Ketorolac

Nepafenac

Study Results

No Results Posted as of Nov 18, 2016