Study of Difluprednate Ophthalmic Emulsion in the Treatme... | NCT00405496

Studies
Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis

NCT00405496

Sponsor

Sirion Therapeutics, Inc.

Status

Completed

Last Update Posted

Nov 30, 2006Estimated

Enrollment

Phase

Phase 2

Conditions

Anterior Uveitis

Interventions

Difluprednate Ophthalmic Emulsion

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2000

Primary Completion Date

Not provided

Completion Date

Apr 2001

First Submitted Date

Nov 29, 2006

First Submission Date that Met QC Criteria

Nov 29, 2006

First Posted Date

Nov 30, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 29, 2006

Last Update Posted Date

Nov 30, 2006Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Difluprednate Ophthalmic Emulsion	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D015864	Panuveitis
D014605	Uveitis
D014603	Uveal Diseases
D005128	Eye Diseases