Nepafenac Compared to Placebo for Ocular Pain and Inflammation

NCT ID: NCT01426854

Last Updated: 2013-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2012-04-30

Brief Summary

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.

Conditions

Cataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Nepafenac Ophthalmic Suspension, 0.1%

Intervention Type: DRUG

Topical ocular administration

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.

Group Type: PLACEBO_COMPARATOR

Nepafenac Vehicle Ophthalmic Solution

Intervention Type: OTHER

Inactive ingredients used as placebo; topical ocular administration

Interventions

Nepafenac Ophthalmic Suspension, 0.1%

Topical ocular administration

Intervention Type: DRUG

Nepafenac Vehicle Ophthalmic Solution

Inactive ingredients used as placebo; topical ocular administration

Intervention Type: OTHER

Eligibility 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;

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mandy Ye, Director

Role: STUDY_DIRECTOR

Alcon (China) Ophthalmic Product Co., Ltd.

Locations

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

C-10-026

Identifier Type: -

Identifier Source: org_study_id