Nepafenac Compared to Placebo for Ocular Pain and Inflammation

NCT01426854 | Completed Phase 3 Results

• 1 other identifier: C-10-026
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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

Keywords

Cataract Surgery; Anti-ocular Inflammation; Anti-ocular Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Proportion of Subjects Who Were Pain-Free at All Postoperative Visits

  Up to Day 14

Study Arms (2)

Nepafenac

ACTIVE COMPARATOR

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%

Placebo

PLACEBO COMPARATOR

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

Interventions

Nepafenac Ophthalmic Suspension, 0.1% DRUG

Topical ocular administration

Nepafenac

Nepafenac Vehicle Ophthalmic Solution OTHER

Inactive ingredients used as placebo; topical ocular administration

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Terence Li, Clinical Research Manager, Development & Medical Affairs, China
• Organization: Alcon (China) Ophthalmic Product Co., Ltd.

Terence.li@alcon.com

+86 10 5829 1452

Study Officials

• Mandy Ye, Director

  Alcon (China) Ophthalmic Product Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2011
• First Posted: September 1, 2011
• Study Start: July 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 13, 2013
• Results First Posted: May 13, 2013

Record last verified: 2013-05

Locations

CN (1)