Study of Difluprednate Ophthalmic Emulsion in the Treatment of Severe Uveitis

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Brief Title

Study of Difluprednate Ophthalmic Emulsion in the Treatment of Severe Uveitis

Official Title

Phase 3 Open-Labeled Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Severe Anterior Uveitis (Including Panuveitis).

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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

The anterior chamber cell score was compared between baseline and Day 14.

Secondary Outcome

 The anterior chamber cell score was compared between baseline and Days 3 and 7.

Condition

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

20

Start Date

August 2002

Completion Date

June 2003


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
      

Gender

All

Ages

12 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Shigeaki Ono, , 



Administrative Informations


NCT ID

NCT00407056

Organization ID

SJE2079/3-02-PC



Study Sponsor

Sirion Therapeutics, Inc.


Study Sponsor

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


Verification Date

November 2006