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

This study has been completed.

Sponsors and Collaborators:	Alcon Research Matthew Caldwell
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00330798

Purpose

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.

Condition	Intervention	Phase
Pain Following Photorefractive Keratectomy (PRK)	Drug: nepafenac	Phase IV

Drug Information available for: Nepafenac Calcium polystyrene sulfonate Polystyrene sulfonic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
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

Further study details as provided by Alcon Research:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	66
Study Start Date:	February 2006

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.

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.

Contacts and Locations

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

Unaffiliated

More Information

Study ID Numbers:	FWH20060020H
Study First Received:	May 25, 2006
Last Updated:	May 25, 2006
ClinicalTrials.gov Identifier:	NCT00330798
Health Authority:	United States: USAF Surgeon General’s Research Oversight Committee

Study placed in the following topic categories:

Signs and Symptoms
Postoperative Complications
Pain
Pain, Postoperative

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 15, 2009