nepafenac compared to placebo for ocular pain and inflammation

Conditions: Cataract

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.

Keywords: cataract surgery anti-ocular inflammation anti-ocular pain