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Nepafenac Compared to Placebo for Ocular Pain and Inflammation

Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cataract

Intervention: Nepafenac Ophthalmic Suspension, 0.1% (Drug); Nepafenac Vehicle Ophthalmic Solution (Other)

Phase: Phase 3

Status: Completed

Sponsored by: Alcon Research

Official(s) and/or principal investigator(s):
Mandy Ye, Director, Study Director, Affiliation: Alcon (China) Ophthalmic Product Co., Ltd.

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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Proportion of Subjects With Clinical Cure at Day 14

Secondary outcome: Proportion of Subjects Who Were Pain-Free at All Postoperative Visits

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

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

Starting date: July 2011
Last updated: May 10, 2013

Page last updated: August 23, 2015

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