Safety and Efficacy of Difluprednate 0.05% for the Treatment of Anterior Uveitis

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to demonstrate that difluprednate 0.05% (Durezol) dosed 4 times daily is noninferior to prednisolone 1% (Pred Forte) dosed 8 times daily for the treatment of endogenous anterior uveitis.

• 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:

• Diagnosis of endogenous anterior uveitis in at least 1 eye.

• The presence of > 10 cells in the anterior chamber of at least one eye, and a flare score of > 2 in that same eye.

• Age 2 years or older on day of consent.

• Negative urine pregnancy test on Day 0 for females of childbearing potential who are not at least 1 year post-menopausal or surgically sterilized.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Presence of endogenous anterior uveitis diagnosed for > 2 weeks prior to enrollment in the study.

• Presence of intermediate uveitis, posterior uveitis or panuveitis in either eye.

• Instillation of any topical corticosteroid or NSAID in the study eye within 7 days of instillation of study drug.

• History of glaucoma or clinically significant ocular hypertension in the opinion of the Investigator involving an IOP ≥ 21 millimeters mercury in either eye.

• History of steroid-induced elevation of intraocular pressure.

• Any confirmed or suspected active viral, bacterial or fungal keratoconjunctival disease in either eye.

• History of glaucoma or clinically significant ocular hypertension in the opinion of the Investigator involving an intraocular pressure (IOP) > 21 mmHg in either eye.

• Corneal abrasion or ulceration in either eye.

• Pregnancy or lactation.

• Other protocol-defined exclusion criteria may apply.