Back to resultsStudy of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis
Primary Purpose
Anterior Uveitis, Panuveitis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Difluprednate Ophthalmic Emulsion
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Uveitis
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
Sites / Locations
Outcomes
Primary Outcome Measures
The difference from the baseline in anterior chamber cell score on Day 14
was compared between the two groups.
Secondary Outcome Measures
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
14 were compared between the two groups.
The differences from the baseline in total sign and symptom scores on Days 3, 7
and 14 were compared between the two groups.
The numbers of patients with an anterior chamber cell score of 1 or less on Days
3, 7 and 14 were compared between the two groups.
Full Information
NCT ID
NCT00406887
First Posted
November 29, 2006
Last Updated
November 29, 2006
Sponsor
Sirion Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00406887
Brief Title
Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis
Official Title
Phase 3 Confirmatory Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Anterior Uveitis (Including Panuveitis).
Study Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sirion Therapeutics, Inc.
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Uveitis, Panuveitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
140 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Difluprednate Ophthalmic Emulsion
Primary Outcome Measure Information:
Title
The difference from the baseline in anterior chamber cell score on Day 14
Title
was compared between the two groups.
Secondary Outcome Measure Information:
Title
The differences from the baseline in anterior chamber cell score on Days 3 and 7
Title
were compared between the two groups.
Title
The numbers of patients with an anterior chamber cell score of 0 on Days 7 and
Title
14 were compared between the two groups.
Title
The differences from the baseline in total sign and symptom scores on Days 3, 7
Title
and 14 were compared between the two groups.
Title
The numbers of patients with an anterior chamber cell score of 1 or less on Days
Title
3, 7 and 14 were compared between the two groups.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shigeaki Ohno, PhD
Organizational Affiliation
Department of Ophthalmology and Visual Science, Graduate School of Medicine, Hokkaido University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis
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