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

NCT ID: NCT00330798

Last Updated: 2016-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2006-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Photorefractive Keratectomy

Keywords

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Photorefractive Keratectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Nevanac

One drop, three times daily, in the assigned eye for the first three postoperative days

Group Type EXPERIMENTAL

nepafenac 0.1%

Intervention Type DRUG

Nepafenac 0.1% randomly assigned to one eye, with ketorolac 0.4% in the fellow eye for contralateral post-surgical use.

Acular LS

One drop, three times daily, in the assigned eye for the first three postoperative days

Group Type PLACEBO_COMPARATOR

ketorolac 0.4%

Intervention Type OTHER

Keterolac 0.4% randomly assigned to one eye, with nepafenac 0.1% in the fellow eye for contralateral post-surgical use.

Interventions

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nepafenac 0.1%

Nepafenac 0.1% randomly assigned to one eye, with ketorolac 0.4% in the fellow eye for contralateral post-surgical use.

Intervention Type DRUG

ketorolac 0.4%

Keterolac 0.4% randomly assigned to one eye, with nepafenac 0.1% in the fellow eye for contralateral post-surgical use.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Matthew Caldwell

UNKNOWN

Sponsor Role collaborator

Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew Caldwell

Role: PRINCIPAL_INVESTIGATOR

Locations

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Lackland Air Force Base

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 18500088 (View on PubMed)

Other Identifiers

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FWH20060020H

Identifier Type: -

Identifier Source: org_study_id