Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study of Difluprednate Ophthalmic Emulsion in the Treatment of Severe Uveitis

This study has been completed.
Sponsor:
Information provided by:
Sirion Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00407056
First received: November 29, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted

November 29, 2006
November 29, 2006
August 2002
Not Provided
The anterior chamber cell score was compared between baseline and Day 14.
Same as current
No Changes Posted
  • 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
  • sign score (sum of anterior chamber cell, anterior chamber flare,
  • ciliary hyperemia, keratic precipitate and synechia of iris and
  • posterior scores) were compared between baseline and Days 3, 7
  • and 14.
Same as current
Not Provided
Not Provided
 
Study of Difluprednate Ophthalmic Emulsion in the Treatment of Severe Uveitis
Phase 3 Open-Labeled Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Severe Anterior Uveitis (Including Panuveitis).

The purpose of this phase 3 open-labeled study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of severe uveitis.

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Uveitis
  • Panuveitis
Drug: Difluprednate Ophthalmic Emulsion
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
June 2003
Not Provided

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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00407056
SJE2079/3-02-PC
Not Provided
Not Provided
Sirion Therapeutics, Inc.
Not Provided
Principal Investigator: Shigeaki Ono Department of Ophthalmology and Visual Science, Graduate School of Medicine, Hokkaido University
Sirion Therapeutics, Inc.
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP