Back to resultsA Comparison of Topical Nepafenac to Placebo in Corneal Epithelial Healing Times and Postoperative Pain Relief
Primary Purpose
Photorefractive Keratectomy
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
nepafenac 0.1%
ketorolac 0.4%
Sponsored by
About this trial
This is an interventional treatment trial for Photorefractive Keratectomy focused on measuring Photorefractive Keratectomy
Eligibility 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.
Sites / Locations
- Lackland Air Force Base
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Nevanac
Acular LS
Arm Description
One drop, three times daily, in the assigned eye for the first three postoperative days
One drop, three times daily, in the assigned eye for the first three postoperative days
Outcomes
Primary Outcome Measures
Subjective pain
Secondary Outcome Measures
Rate of epithelial healing
Full Information
NCT ID
NCT00330798
First Posted
May 25, 2006
Last Updated
November 17, 2016
Sponsor
Alcon Research
Collaborators
Matthew Caldwell
1. Study Identification
Unique Protocol Identification Number
NCT00330798
Brief Title
A Comparison of Topical Nepafenac to Placebo in Corneal Epithelial Healing Times and Postoperative Pain Relief
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 Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
Collaborators
Matthew Caldwell
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Photorefractive Keratectomy
Keywords
Photorefractive Keratectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nevanac
Arm Type
Experimental
Arm Description
One drop, three times daily, in the assigned eye for the first three postoperative days
Arm Title
Acular LS
Arm Type
Placebo Comparator
Arm Description
One drop, three times daily, in the assigned eye for the first three postoperative days
Intervention Type
Drug
Intervention Name(s)
nepafenac 0.1%
Intervention Description
Nepafenac 0.1% randomly assigned to one eye, with ketorolac 0.4% in the fellow eye for contralateral post-surgical use.
Intervention Type
Other
Intervention Name(s)
ketorolac 0.4%
Intervention Description
Keterolac 0.4% randomly assigned to one eye, with nepafenac 0.1% in the fellow eye for contralateral post-surgical use.
Primary Outcome Measure Information:
Title
Subjective pain
Time Frame
Day 5
Secondary Outcome Measure Information:
Title
Rate of epithelial healing
Time Frame
Time to event
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Caldwell
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lackland Air Force Base
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78236
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18500088
Citation
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.
Results Reference
result
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A Comparison of Topical Nepafenac to Placebo in Corneal Epithelial Healing Times and Postoperative Pain Relief
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