Nepafenac Compared to Placebo for Ocular Pain and Inflammation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01426854
First received: August 30, 2011
Last updated: May 10, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Cataract
Drug: Nepafenac Ophthalmic Suspension, 0.1%
Other: Nepafenac Vehicle Ophthalmic Solution
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Proportion of Subjects With Clinical Cure at Day 14 [ Time Frame: Day 14 postoperative ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Proportion of Subjects Who Were Pain-Free at All Postoperative Visits [ Time Frame: Up to Day 14 ] [ Designated as safety issue: No ]
    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.


Enrollment: 260
Study Start Date: July 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01426854

Locations
China, Guangdong
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Mandy Ye, Director Alcon (China) Ophthalmic Product Co., Ltd.
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01426854     History of Changes
Other Study ID Numbers: C-10-026
Study First Received: August 30, 2011
Results First Received: March 27, 2013
Last Updated: May 10, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Alcon Research:
Cataract Surgery
Anti-ocular Inflammation
Anti-ocular Pain

Additional relevant MeSH terms:
Inflammation
Cataract
Pathologic Processes
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014