Nepafenac Compared to Placebo for Ocular Pain and Inflammation

Clinical Evaluation of Safety and Efficacy of Nepafenac Ophthalmic Suspension, 0.1% Compared to Placebo for the Prevention and Treatment of Ocular Inflammation and Pain Associated With Cataract Surgery in Adult Chinese Subjects

The purpose of this study was to demonstrate that Nepafenac Ophthalmic Suspension, 0.1% is superior to Nepafenac Vehicle (placebo) for the prevention and treatment of ocular inflammation and pain associated with cataract surgery in Chinese subjects.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 260
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Zhongshan Ophthalmic Center, Sun Yat-sen University

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:

• Adult Chinese subjects, 18 years of age or older, of either sex who have a cataract, and are expected to undergo cataract extraction with the implantation of a posterior chamber intraocular lens;
• Study eye of subjects, who in the opinion of the Investigator, will have improvement in best-corrected visual acuity after surgery;
• Subjects should be able to understand and sign an informed consent that has been approved by an Independent Ethics Committee;
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Use of topical ocular or systemic steroids within 14 days prior to surgery;
• Use of topical ocular or systemic non-steroidal anti-inflammatory drugs within 7 days of surgery, except an allowed daily dose of baby aspirin (81 mg);
• Subjects planning to have cataract surgery in their fellow, non-study eye prior to the 14 day postoperative study visit;
• Any intraocular inflammation or ocular pain greater than Grade 0 in the study eye that is present during the baseline slit-lamp exam;

• Women of childbearing potential (those who are not surgically sterilized or post menopausal) may not participate in the study if any of the following conditions exist:

  • they are breast feeding;
  • they have a positive urine pregnancy test at baseline;
  • they are not willing to undergo a urine pregnancy test upon exiting the study;
  • they intend to become pregnant during the duration of the study; or,
  • they do not agree to using adequate birth control methods for the duration of the study.
• Any abnormality that prevents reliable tonometry;
• Planned multiple procedures during cataract/IOL implantation surgery;
• Lens pseudoexfoliation syndrome with glaucoma or zonular compromise;
• Previous ocular trauma to the operative eye;
• A history of chronic or recurrent inflammatory eye disease;
• Ocular infection or ocular pain;
• Proliferative diabetic retinopathy;
• Uncontrolled diabetes mellitus;
• Congenital ocular anomaly;
• Iris atrophy in the operative eye;
• A nonfunctional fellow eye;
• Use of an investigational intraocular lens;
• Participation in any other clinical study within 30 days before surgery;
• Known or suspected allergy or hypersensitivity to non-steroidal anti-inflammatory agents, or to any component of the study medication;
• Subjects with known bleeding tendencies, or who are receiving medications that may prolong bleeding time, may be enrolled at the physician's discretion; continuation of previous therapy for these subjects will be left to the judgment of the physician;
• The fellow eye of an individual currently or previously enrolled in the study;
• Subjects using a topical ophthalmic prostaglandin;
• Subjects, who in the opinion of the investigator, might be at increased risk of complications from topical NSAIDs;
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nepafenac; Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.	Drug: Nepafenac Ophthalmic Suspension, 0.1%; Topical ocular administration
Placebo Comparator: Placebo; Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.	Other: Nepafenac Vehicle Ophthalmic Solution; Inactive ingredients used as placebo; topical ocular administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Subjects With Clinical Cure 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 aqueous cells and aqueous flare. The proportion of subjects with a clinical cure is reported as percentage.	Day 14 postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Subjects Who Were Pain-Free at All Postoperative Visits	Ocular pain is defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. The Investigator scored ocular pain based on the description of pain by the subject. Pain was scored on a 6-unit scale ranging from 0 (none, absence of positive sensation) to 5 (severe, subject reports intense ocular, periocular or radiating pain requiring prescription analgesic). To be considered pain-free at all post operative visits, the patient must have had a score of 0 at Days 1, 3, 7, and 14 and any unscheduled visit. The proportion of subjects who were pain-free at all post-operative visits is reported as percentage.	Up to Day 14

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Mandy Ye, Director, Alcon (China) Ophthalmic Product Co., Ltd.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: August 30, 2011
• First Submitted That Met QC Criteria: August 31, 2011
• First Posted (Estimate): September 1, 2011

Study Record Updates

• Last Update Posted (Estimate): May 13, 2013
• Last Update Submitted That Met QC Criteria: May 10, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Cataract Surgery; Anti-ocular Inflammation; Anti-ocular Pain
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Lens Diseases; Inflammation; 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; Pharmaceutical Solutions; Ophthalmic Solutions; Nepafenac
• Other Study ID Numbers: C-10-026