Study of Difluprednate Ophthalmic Emulsion in the Treatme... | NCT00407056

Studies
Study of Difluprednate Ophthalmic Emulsion in the Treatment of Severe Uveitis

NCT00407056

Sponsor

Sirion Therapeutics, Inc.

Status

Completed

Last Update Posted

Dec 4, 2006Estimated

Enrollment

Phase

Phase 3

Conditions

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

Jun 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 open-labeled study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of severe uveitis.

Detailed Description

The objective of this phase 3 study is to assess the efficacy and safety of 0.05% difluprednate ophthalmic emulsion in patients with severe endogenous anterior uveitis with an open-labeled, no-controlled and no-randomized design.

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

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

Measure	Description	Time Frame
The anterior chamber cell score was compared between baseline and Day 14.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with a diagnosis of endogenous anterior uveitis or panuveitis
Patients with ≥ 50 anterior chamber cells as observed by slit lamp microscopy (criterion for evaluation of signs 4)
Patients requiring more frequent instillation of 0.1% betamethasone sodium phosphate ophthalmic solution than the regular frequency specified in its dosage and administration (3 - 4 times/day)
Patients aged ≥ 12 years (on the day of obtaining informed consent) who were able to actuate symptoms
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 initiating treatment with systemic administration of any corticosteroid, non-steroidal anti-inflammatory drug, antiphlogistic enzyme or immunosuppressive drug within 2 weeks before instillation of the investigational drug
Patients receiving topical injection of any corticosteroid in eyes before instillation of the investigational product(solution formulation: within 1 week before instillation of the investigational product, depot formulation: within 2 weeks before instillation of the investigational product)
Patients receiving instillation of any corticosteroid, non-steroidal anti-inflammatory ophthalmic solution or antiphologistic enzyme within 12 hours before instillation of the investigational drug
Patients with glaucoma or ocular hypertension
Patients with corneal erosion or corneal ulcer
Patients with any viral, bacterial or fungal keratoconjunctival disease or suspected with eye infection
Patients with allergy to similar drugs of difluprednate
Patients requiring use of contact lens during the study period
Women who were or might be pregnant, or lactating women
Patients participating in another clinical study within 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
D014603	Uveal Diseases
D005128	Eye Diseases

Measure	Description	Time Frame
The anterior chamber cell score was compared between baseline and Days 3 and 7.
The total symptom score (sum of eye pain, photophobia, blurred
vision, foreign body sensation and lacrimation scores) and total

ID	Term
D014605	Uveitis
D015864	Panuveitis