Clinical trial NCT00406887: Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis
Official title: Phase 3 Confirmatory Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Anterior Uveitis (Including Panuveitis).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anterior Uveitis
Panuveitis
Lead sponsor: Sirion Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2006-12-04
Enrollment: 140
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: The difference from the baseline in anterior chamber cell score on Day 14
measure: was compared between the two groups.
Secondary outcomes:
measure: The differences from the baseline in anterior chamber cell score on Days 3 and 7
measure: were compared between the two groups.
measure: The numbers of patients with an anterior chamber cell score of 0 on Days 7 and
measure: 14 were compared between the two groups.
measure: The differences from the baseline in total sign and symptom scores on Days 3, 7
measure: and 14 were compared between the two groups.
measure: The numbers of patients with an anterior chamber cell score of 1 or less on Days
measure: 3, 7 and 14 were compared between the two groups.
Other outcomes:
Locations:
Study officials:
affiliation: Department of Ophthalmology and Visual Science, Graduate School of Medicine, Hokkaido University
name: Shigeaki Ohno, PhD
role: PRINCIPAL_INVESTIGATOR
References: