Study of Difluprednate Ophthalmic Emulsion in the Treatment of Severe Uveitis

Phase 3 Open-Labeled Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Severe Anterior Uveitis (Including Panuveitis).

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

The objective of this phase 3 study is to assess the efficacy and safety of 0.05% difluprednate ophthalmic emulsion in patients with severe endogenous anterior uveitis with an open-labeled, no-controlled and no-randomized design.

Inclusion Criteria:

• Patients with a diagnosis of endogenous anterior uveitis or panuveitis
• Patients with ≥ 50 anterior chamber cells as observed by slit lamp microscopy (criterion for evaluation of signs 4)
• Patients requiring more frequent instillation of 0.1% betamethasone sodium phosphate ophthalmic solution than the regular frequency specified in its dosage and administration (3 - 4 times/day)
• Patients aged ≥ 12 years (on the day of obtaining informed consent) who were able to actuate symptoms
• Patients giving written informed consent prior to initiation of the study

Exclusion Criteria:

• Patients who did not meet all of the above inclusion criteria
• Patients initiating treatment with systemic administration of any corticosteroid, non-steroidal anti-inflammatory drug, antiphlogistic enzyme or immunosuppressive drug within 2 weeks before instillation of the investigational drug
• Patients receiving topical injection of any corticosteroid in eyes before instillation of the investigational product(solution formulation: within 1 week before instillation of the investigational product, depot formulation: within 2 weeks before instillation of the investigational product)
• Patients receiving instillation of any corticosteroid, non-steroidal anti-inflammatory ophthalmic solution or antiphologistic enzyme within 12 hours before instillation of the investigational drug
• Patients with glaucoma or ocular hypertension
• Patients with corneal erosion or corneal ulcer
• Patients with any viral, bacterial or fungal keratoconjunctival disease or suspected with eye infection
• Patients with allergy to similar drugs of difluprednate
• Patients requiring use of contact lens during the study period
• Women who were or might be pregnant, or lactating women
• Patients participating in another clinical study within 3 months before initiation of the present study