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

Phase 4

Completed

• Conditions: Photorefractive Keratectomy
• Interventions: Drug: nepafenac 0.1%; Other: ketorolac 0.4%

• Registration Number: NCT00330798
• Lead Sponsor: Alcon Research

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-05-25
• Study First Submitted QC: 2006-05-25
• Study First Posted: 2006-05-29
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Status Verified: 2012-05
• Last Update Submitted: 2016-11-17
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nevanac	nepafenac 0.1%	One drop, three times daily, in the assigned eye for the first three postoperative days
Acular LS	ketorolac 0.4%	One drop, three times daily, in the assigned eye for the first three postoperative days

Primary Outcome Measures

Name	Time	Method
Subjective pain	Day 5

Secondary Outcome Measures

Name	Time	Method
Rate of epithelial healing	Time to event

Trial Locations

Locations (1)

Lackland Air Force Base; 🇺🇸 San Antonio, Texas, United States