Confirmatory Study Nepafenac 0.3%

Clinical Evaluation of Nepafenac Ophthalmic Suspension, 0.3% for Prevention and Treatment of Ocular Inflammation and Pain After Cataract Surgery

The purpose of this study was to assess the safety and efficacy of an investigational eye drop intended for the prevention and treatment of inflammation (swelling and redness) and pain in the eye after cataract extraction.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Drug: Nepafenac Ophthalmic Suspension, 0.3%; Drug: Nepafenac Ophthalmic Suspension, 0.1%; Other: Nepafenac Ophthalmic Suspension 0.3% Vehicle; Other: NEVANAC Vehicle

• Study Type: Interventional
• Enrollment (Actual): 2120
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76134
      • Contact Alcon Call Center for Trial Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Nepafenac 0.3%; Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.	Drug: Nepafenac Ophthalmic Suspension, 0.3%; Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days. An additional dose was administered between 30-120 minutes prior to surgery.
ACTIVE_COMPARATOR: NEVANAC; Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.	Drug: Nepafenac Ophthalmic Suspension, 0.1%; Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, for 16 days; Other Names: NEVANAC®
PLACEBO_COMPARATOR: Nepafenac Vehicle 0.3%; Nepafenac Ophthalmic Suspension 0.3% Vehicle, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.	Other: Nepafenac Ophthalmic Suspension 0.3% Vehicle; Nepafenac 0.3% vehicle, one drop in affected eye once daily, for 16 days. An additional dose was administered between 30-120 minutes prior to surgery.
PLACEBO_COMPARATOR: NEVANAC Vehicle; Nepafenac 0.1% vehicle, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.	Other: NEVANAC Vehicle; Nepafenac vehicle, one drop in affected eye three times daily, for 16 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients Cured at Day 14	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 cells and flare.	Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients Pain-Free at Day 14	Ocular pain as assessed by the investigator on a scale ranging from 0 (none) to 5 (severe). Pain-free was defined as a score of 0 on the investigator's assessment of ocular pain.	Day 14

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Dana Sager, MS, Alcon Research

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (ACTUAL): May 1, 2011

Study Registration Dates

• First Submitted: April 21, 2010
• First Submitted That Met QC Criteria: April 22, 2010
• First Posted (ESTIMATE): April 23, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): November 30, 2012
• Last Update Submitted That Met QC Criteria: November 29, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Nepafenac
• Other Study ID Numbers: C-09-055