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

Completed · Phase 3

Conditions studied: Cataracts, Inflammation

In brief

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.

Key facts

Study ID

NCT01124045

Run by

Alcon Research

People needed

80

Starts

2010-08-01

Expected to finish

2012-04-01

Last updated by the study team

2013-06-19

Who can join

Age: any, up to 3. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Contact Alcon Call Center For Trial Locations — Fort Worth, Texas, United States

Full record on ClinicalTrials.gov

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