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 - Tabular View

Tracking Information

First Received Date ^ICMJE

May 25, 2006

Last Updated Date

May 25, 2006

Start Date ^ICMJE

February 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Patients were asked to rate the level of pain in each eye for the first three to five days after surgery.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Also, patients were examined daily for the first three to five days until corneal epithelial closure to evaluate the rate of epithelial healing.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Brief Summary

Nepafenac 0.1% or placebo (Balanced Salt Solution, BSS), 1 drop three times daily in contralateral eyes until healed.

To determine the comparable subjective pain level healing times of corneal epithelium (time to epithelial closure) after photorefractive keratectomy (PRK), while using either the commercial topical preparation of nepafenac (0.1%) or placebo.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Condition ^ICMJE

Pain Following Photorefractive Keratectomy (PRK)

Intervention ^ICMJE

Drug: nepafenac

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

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.

Gender

Both

Ages

19 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00330798

Responsible Party

Study ID Numbers ^ICMJE

FWH20060020H

Study Sponsor ^ICMJE

Alcon Research

Collaborators ^ICMJE

Matthew Caldwell

Investigators ^ICMJE

Principal Investigator:

Matthew Caldwell

Unaffiliated

Information Provided By

Alcon Research

Verification Date

May 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP