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OpenTrials
Completed

NCT Number: NCT00330798

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

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.

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Key information

Conditions

Photorefractive Keratectomy

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Lackland Air Force Base

San Antonio, Texas, 78236, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nepafenac 0.1%

Drug

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

ketorolac 0.4%

Other

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

Primary outcomes

  1. Subjective pain

    Time frame: Day 5

Secondary outcomes

  1. Rate of epithelial healing

    Time frame: Time to event

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Collaborators

  • Matthew Caldwell

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
May 29, 2006
Registry last updated
Nov 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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