Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis

Phase 3 Confirmatory Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Anterior Uveitis (Including Panuveitis).

The purpose of this phase 3 confirmatory study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of treatment of uveitis.

The objective of this phase 3 study is to assess the efficacy and safety of 0.05% difluprednate ophthalmic emulsion (DFBA) in patients with endogenous anterior uveitis, in comparison with 0.1% betamethasone sodium phosphate ophthalmic solution (BP).

Inclusion Criteria:

• Patients diagnosed with endogenous anterior uveitis or panuveitis
• Patients with 10 - 49 anterior chamber cells within one field of the anterior chamber as observed by slit lamp microscopy (criterion for rating of signs 2 or 3)
• Patients aged ‰1425 years (on the day of obtaining informed consent) who were able to accurately express their own symptoms
• Patients provided written informed consent prior to initiation of the study

Exclusion Criteria:

• Patients who did not meet all of the above inclusion criteria
• Patients received systemic administration of any corticosteroid or immunosuppressive drug within the past 1 week prior to instillation of the investigational product
• Patients received topical injection of any corticosteroid in eyes prior to instillation of the investigational product (Solution formulation: within the past 1 week, depot: within the past 2 weeks)
• Patients received systemic administration of any non-steroidal anti-inflammatory drug or antiphlogistic enzyme within the past 3 days prior to instillation of the investigational product
• Patients received instillation of any corticosteroid, non-steroidal anti-inflammatory drug or antiphlogistic enzyme within 12 hours prior to instillation of the investigational product
• Patients with glaucoma or ocular hypertension
• Patients with corneal abrasion or ulcer
• Patients with any confirmed or suspected viral, bacterial or fungal keratoconjunctival disease
• Patients with allergy to similar drugs such as other corticosteroids
• Patients requiring use of contact lens during the study period
• Women who are or might be pregnant, or lactating women
• Patients participating in another clinical study within the past 3 months before initiation of the present study