Nepafenac 0.3% Two Study

Alcon Research1,342 enrolled

Overview

The purpose of this study was to assess the safety and efficacy of Nepafenac Ophthalmic Suspension, 0.3% for the prevention and treatment of inflammation (swelling and redness) and pain in the eye after cataract extraction.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

1,342

Conditions

Cataract

Interventions

Nepafenac Ophthalmic Suspension, 0.3%DRUG

Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days. An additional drop was administered between 30-120 minutes prior to surgery.

Nepafenac Ophthalmic Suspension, 0.1%DRUG

Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days. An additional drop was administered between 30-120 minutes prior to surgery.

Nepafenac Vehicle 0.3%OTHER

Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days. An additional drop was administered between 30-120 minutes prior to surgery.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Planned cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens; * Patients who, in the opinion of the Investigator, would have improvement in best-corrected visual acuity after surgery; * Able to understand and sign an informed consent; * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Use of topical ocular, inhaled or systemic nonsteroidal anti-inflammatory drugs within 7 days of surgery, with the exception of the allowed low dose of aspirin (up to 100 mg) prior to surgery and through study exit; * Use of topical ocular, inhaled or systemic steroids within 14 days prior to surgery and through study exit; * History of chronic or recurrent inflammatory eye disease (eg, iritis, scleritis, uveitis, iridocyclitis, rubeosis iridis) in the operative eye; * Diabetic retinopathy in the operative eye; * Known or suspected allergy or hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), or to any component of the test article; * Other protocol-defined exclusion criteria may apply.

Locations (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Outcomes

Primary Outcomes

Percentage of Patients Cured at Day 14, Nepafenac 0.3% vs. Nepafenac Vehicle 0.3%

Ocular inflammation was assessed by the investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (\> 30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). To be considered cured, the patient must have had a score of 0 for both aqueous cells and aqueous flare.

Time frame: Day 14 postoperative

Secondary Outcomes

Percentage of Patients Cured at Day 7, Nepafenac 0.3% vs. Nepafenac 0.1%

Time frame: Day 7 postoperative

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.