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

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Difluprednate; Fluprednisolone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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.