Overview

Nepafenac Compared to Placebo for Ocular Pain and Inflammation

Status:
Completed
Trial end date:
2012-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Alcon Research
Treatments:
Nepafenac
Ophthalmic Solutions
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.