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Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis

Primary Purpose

Anterior Uveitis

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Difluprednate Ophthalmic Emulsion

About this trial

This is an interventional treatment trial for Anterior Uveitis

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

The anterior chamber cell score was compared between baseline and after completion of the

study treatment (14 +/- 2 days). The efficacy was evaluated with a 4-point scale based on the

reduction of anterior chamber cell.

Secondary Outcome Measures

The overall efficacy was evaluated with a 4-point-scale based on the change in the flare value

(baseline/after completion of the study treatment ratio), as measured with a laser flare cell

meter, and those in anterior chamber flare as measured with a slitlamp microscope and clinical

signs and symptoms after completion of the study treatment (142 days) from baseline.

Full Information

NCT ID

NCT00405496

First Posted

November 29, 2006

Last Updated

November 29, 2006

Sponsor

Sirion Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00405496

Brief Title

Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2006

Overall Recruitment Status

Completed

Study Start Date

March 2000 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2001 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Sirion Therapeutics, Inc.

4. Oversight

5. Study Description

Brief Summary

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

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anterior Uveitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

24 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Difluprednate Ophthalmic Emulsion

Primary Outcome Measure Information:

Title

The anterior chamber cell score was compared between baseline and after completion of the

Title

study treatment (14 +/- 2 days). The efficacy was evaluated with a 4-point scale based on the

Title

reduction of anterior chamber cell.

Secondary Outcome Measure Information:

Title

The overall efficacy was evaluated with a 4-point-scale based on the change in the flare value

Title

(baseline/after completion of the study treatment ratio), as measured with a laser flare cell

Title

meter, and those in anterior chamber flare as measured with a slitlamp microscope and clinical

Title

signs and symptoms after completion of the study treatment (142 days) from baseline.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kanjiro Masudo

Organizational Affiliation

Director, Kanto Rosai Hospital

Official's Role

Study Chair

12. IPD Sharing Statement

Learn more about this trial

Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis

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