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
Information source: Alcon Research
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain Following Photorefractive Keratectomy (PRK)
Intervention: nepafenac (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Alcon Research Official(s) and/or principal investigator(s):
Matthew Caldwell, Principal Investigator, Affiliation: Unaffiliated
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.
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: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Primary outcome: Patients were asked to rate the level of pain in each eye for the first three to five days after surgery.
Secondary outcome: Also, patients were examined daily for the first three to five days until corneal epithelial closure to evaluate the 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.
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.
Locations and Contacts
Lackland Air Force Base, San Antonio, Texas 78236, United States
Additional Information
Starting date: February 2006
Last updated: May 25, 2006
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