Overview

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.