Difluprednate Pediatric Study for the Treatment of Inflammation Post-Cataract Surgery

A Phase IIIB, Multicenter, Randomized, Double-Masked, Parallel-Group, Active-Controlled Study of the Safety and Efficacy of Difluprednate Ophthalmic Emulsion, 0.05% (Durezol™) 4 Times Daily (QID) and Prednisolone Acetate Ophthalmic Suspension, 1.0% (Pred Forte™) QID for the Treatment of Inflammation Following Cataract Surgery in Children 0 to 3 Years of Age

The primary objective of this study was to compare the safety and efficacy of Durezol™ compared to Pred Forte™ for the treatment of inflammation following cataract surgery in a pediatric population 0 to 3 years of age.

Parents or guardians instilled patients' assigned study medications once on the day of surgery (Day 0) and 4 times daily (QID) beginning on the day after surgery (Day 1) for 14 days followed by a tapering period of 14 days (dependent upon the Investigator's determination of adequate response to treatment). Patients were evaluated for safety and efficacy on the following visits: Day 0 (day of surgery), Day 1, Day 8 ± 1 day, Day 15 ± 2 days and Day 29 ± 2 days (end of study drug treatment). Additional safety visits occurred at 1 week after the last dose + 2 days and at 3 Months + 1 week. No inferential statistical analysis was planned for this study. Data was summarized using descriptive statistics.

Inclusion Criteria:

• 0 to 3 years of age.
• Undergoing uncomplicated cataract extraction in 1 eye with or without intraocular lens.
• Informed consent signed by a parent or legal guardian.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Presence of any active or suspected viral, bacterial, or fungal disease in the study eye.
• Use of any topical medication in the study within 7 days prior to surgery, except for drops that are needed to examine the eye or to prepare for surgery.
• Patients with posttraumatic cataract.
• Active uveitis in the study eye.
• Ocular neoplasm in the study eye.
• Human immunodeficiency virus (HIV); acquired immunodeficiency syndrome (AIDS).
• Suspected permanent low vision or blindness in the fellow nonstudy eye. The study eye must not be the patient's only good eye.
• Patients on systemic steroids or nonsteroidal anti-inflammatory drugs.
• History of steroid-induced intraocular pressure (IOP) rise.
• Currently on medication for ocular hypertension or glaucoma in the study eye.
• Diabetes.
• Other protocol-defined exclusion criteria may apply.