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

Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Photorefractive Keratectomy

Intervention: nepafenac 0.1% (Drug); ketorolac 0.4% (Other)

Phase: Phase 4

Status: Completed

Sponsored by: Alcon Research

Official(s) and/or principal investigator(s):
Matthew Caldwell, Principal Investigator

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.

Clinical Details

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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Subjective pain

Secondary outcome: Rate of epithelial healing

Eligibility

Minimum age: 19 Years. Maximum age: N/A. Gender(s): Both.

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.

- 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.

Locations and Contacts

Lackland Air Force Base, San Antonio, Texas 78236, United States
Additional Information

Starting date: February 2006
Last updated: May 22, 2012

Page last updated: August 23, 2015

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