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

Alcon

Status and phase: Completed; Phase 4

Conditions: Photorefractive Keratectomy

Treatments: Other: ketorolac 0.4%; Drug: nepafenac 0.1%

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT00330798

FWH20060020H

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Nevanac

Experimental group

Description:

One drop, three times daily, in the assigned eye for the first three postoperative days

Treatment:

Drug: nepafenac 0.1%

Acular LS

Placebo Comparator group

Description:

One drop, three times daily, in the assigned eye for the first three postoperative days

Treatment:

Other: ketorolac 0.4%