Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis

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

Detailed Description
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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).

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

Conditions
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Anterior Uveitis, Panuveitis

Intervention / Treatment
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* Drug: Difluprednate Ophthalmic Emulsion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Difluprednate Ophthalmic Emulsion|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference from the baseline in anterior chamber cell score on Day 14 |  |  | 
| was compared between the two groups. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The differences from the baseline in anterior chamber cell score on Days 3 and 7 |  |  | 
| were compared between the two groups. |  |  | 
| The numbers of patients with an anterior chamber cell score of 0 on Days 7 and |  |  | 
| 14 were compared between the two groups. |  |  | 
| The differences from the baseline in total sign and symptom scores on Days 3, 7 |  |  | 
| and 14 were compared between the two groups. |  |  | 
| The numbers of patients with an anterior chamber cell score of 1 or less on Days |  |  | 
| 3, 7 and 14 were compared between the two groups. |  |  |