Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis

Panuveitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00406887
• Other study ID #: SJE2079/3-01-PC
• Status: Completed
• Phase: Phase 3
• First received: November 29, 2006
• Last updated: November 29, 2006
• Start date: August 2002
• Est. completion date: November 2003

Study information

• Verified date: November 2006
• Source: Sirion Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: November 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anterior Uveitis
• Iridocyclitis
• Iritis
• Panuveitis
• Uveitis
• Uveitis, Anterior

Intervention

Drug:
• Difluprednate Ophthalmic Emulsion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sirion Therapeutics, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference from the baseline in anterior chamber cell score on Day 14
Primary	was compared between the two groups.
Secondary	The differences from the baseline in anterior chamber cell score on Days 3 and 7
Secondary	were compared between the two groups.
Secondary	The numbers of patients with an anterior chamber cell score of 0 on Days 7 and
Secondary	14 were compared between the two groups.
Secondary	The differences from the baseline in total sign and symptom scores on Days 3, 7
Secondary	and 14 were compared between the two groups.
Secondary	The numbers of patients with an anterior chamber cell score of 1 or less on Days
Secondary	3, 7 and 14 were compared between the two groups.