Nepafenac Compared to Placebo for Ocular Pain and Inflammation
Condition: Cataract
MeSH terms: Cataract; Inflammation
Intervention: Nepafenac Ophthalmic Suspension, 0.1%; Nepafenac Vehicle Ophthalmic Solution
Intervention description: Topical ocular administration; Inactive ingredients used as placebo; topical ocular administration
Intervention MeSH terms: Nepafenac; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 260.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cataract Surgery; Anti-ocular Inflammation; Anti-ocular Pain

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.
    

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;

          -  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.