Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis

Anterior Uveitis Clinical Trial

Official title:

Phase 2a Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Anterior Uveitis (Inluding Iritis, Cyclitis, Iridocyclitis, and Panuveitis).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00405496
• Other study ID #: SJE2079/2-02-PC
• Status: Completed
• Phase: Phase 2
• First received: November 29, 2006
• Last updated: November 29, 2006
• Start date: March 2000
• Est. completion date: April 2001

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 2 study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of uveitis.

Description:

The primary objective was to investigate the efficacy and safety of 0.05% difluprednate ophthalmic emulsion in patients with endogenous anterior uveitis and to determine its clinical usefulness for treatment of this disease in the early phase of development, in comparison with Rinderon® solution (containing 0.1% betamethasone sodium phosphate) that has widely been used for treatment of postoperative inflammation, uveitis, etc. as a steroid ophthalmic solution.

The secondary objective was to establish the evaluation system for a dose-finding study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients with endogenous anterior uveitis (including panuveitis)

• Patients with 20 or more anterior chamber cell within one field of the aqueous humor (Grade 3 or higher in clinical signs and grading) as measured with a slitlamp microscope

• Patients aged =20 years and <75 years who could clearly express their subjective symptoms (Patients aged 20 years at giving informed consent were included in the study.)

• 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 receiving systemic administration or topical administration to the head or face including instillation of corticosteroid, nonsteroidal anti-inflammatory drugs, antiphlogistic enzymes, immunosuppressive drugs or colchicines within 1 week before the initial instillation of the study drug

• Patients with glaucoma or ocular hypertension (IOP =21 mmHg)

• Patients with corneal erosion or corneal ulcer

• Patients with viral keratoconjunctival diseases, tuberculos eye diseases, fungal eye diseases or bacterial eye diseases

• Patients with diabetes mellitus

• Patients with allergy to corticosteroids

• Patients requiring use of contact lens during the study period

• Women who were or might be pregnant

• Patients participating in other clinical studies within 6 months before initiation of the present study

• Patients with sensitivity to steroids(Patients who previously exhibited increased IOP after instillation of a steroid ophthalmic solution)

• Patients with fibrins to such an extent that might affect measurement of flare

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
• 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 anterior chamber cell score was compared between baseline and after completion of the
Primary	study treatment (14 +/- 2 days). The efficacy was evaluated with a 4-point scale based on the
Primary	reduction of anterior chamber cell.
Secondary	The overall efficacy was evaluated with a 4-point-scale based on the change in the flare value
Secondary	(baseline/after completion of the study treatment ratio), as measured with a laser flare cell
Secondary	meter, and those in anterior chamber flare as measured with a slitlamp microscope and clinical
Secondary	signs and symptoms after completion of the study treatment (14?2 days) from baseline.