Study of Difluprednate Ophthalmic Emulsion in the Treatme... | NCT00406887

Studies
Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis

NCT00406887

Sponsor

Sirion Therapeutics, Inc.

Status

Completed

Last Update Posted

Dec 4, 2006Estimated

Enrollment

140

Phase

Phase 3

Conditions

Anterior Uveitis
Panuveitis

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

Aug 2002

Primary Completion Date

Not provided

Completion Date

Nov 2003

First Submitted Date

Nov 29, 2006

First Submission Date that Met QC Criteria

Nov 29, 2006

First Posted Date

Dec 4, 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

Dec 4, 2006Estimated

Description Module

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).

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The difference from the baseline in anterior chamber cell score on Day 14
was compared between the two groups.

Secondary Outcomes

Measure	Description	Time Frame
The differences from the baseline in anterior chamber cell score on Days 3 and 7
were compared between the two groups.
The numbers of patients with an anterior chamber cell score of 0 on Days 7 and

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D014606	Uveitis, Anterior
D015864	Panuveitis

ID	Term
D014605	Uveitis
D014603	Uveal Diseases
D005128	Eye Diseases