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

Photorefractive Keratectomy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00330798
• Other study ID #: FWH20060020H
• Status: Completed
• Phase: Phase 4
• First received: May 25, 2006
• Last updated: November 17, 2016
• Start date: February 2006
• Est. completion date: June 2006

Study information

• Verified date: May 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Photorefractive Keratectomy

Intervention

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

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

Locations

Country	Name	City	State
United States	Lackland Air Force Base	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Alcon Research	Matthew Caldwell

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective pain		Day 5	No
Secondary	Rate of epithelial healing		Time to event	No