Status:
COMPLETED
Nepafenac Compared to Placebo for Ocular Pain and Inflammation
Lead Sponsor:
Alcon Research
Conditions:
Cataract
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 asso...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT01426854
Start Date
July 1 2011
End Date
April 1 2012
Last Update
May 13 2013
Active Locations (1)
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1
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060