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

Alcon Research40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Photorefractive Keratectomy

Interventions

nepafenac 0.1%DRUG

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

ketorolac 0.4%OTHER

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

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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 (1)

Lackland Air Force Base

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Subjective pain

Time frame: Day 5

Secondary Outcomes

Rate of epithelial healing

Time frame: Time to event

Data from ClinicalTrials.gov

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