Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis

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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).

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).
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

The difference from the baseline in anterior chamber cell score on Day 14

Secondary Outcome

 The differences from the baseline in anterior chamber cell score on Days 3 and 7

Condition

Anterior Uveitis

Intervention

Difluprednate Ophthalmic Emulsion


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

140

Start Date

August 2002

Completion Date

November 2003


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
      

Gender

All

Ages

12 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Shigeaki Ohno, PhD, , 



Administrative Informations


NCT ID

NCT00406887

Organization ID

SJE2079/3-01-PC



Study Sponsor

Sirion Therapeutics, Inc.


Study Sponsor

Shigeaki Ohno, PhD, Principal Investigator, Department of Ophthalmology and Visual Science, Graduate School of Medicine, Hokkaido University


Verification Date

November 2006