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Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis

This study has been completed.
Sponsor:
Information provided by:
Sirion Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00405496
First received: November 29, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted

November 29, 2006
November 29, 2006
March 2000
Not Provided
  • The anterior chamber cell score was compared between baseline and after completion of the
  • study treatment (14 +/- 2 days). The efficacy was evaluated with a 4-point scale based on the
  • reduction of anterior chamber cell.
Same as current
No Changes Posted
  • The overall efficacy was evaluated with a 4-point-scale based on the change in the flare value
  • (baseline/after completion of the study treatment ratio), as measured with a laser flare cell
  • meter, and those in anterior chamber flare as measured with a slitlamp microscope and clinical
  • signs and symptoms after completion of the study treatment (142 days) from baseline.
Same as current
Not Provided
Not Provided
 
Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis
Phase 2a Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Anterior Uveitis (Inluding Iritis, Cyclitis, Iridocyclitis, and Panuveitis).

The purpose of this phase 2 study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of uveitis.

The primary objective was to investigate the efficacy and safety of 0.05% difluprednate ophthalmic emulsion in patients with endogenous anterior uveitis and to determine its clinical usefulness for treatment of this disease in the early phase of development, in comparison with Rinderon® solution (containing 0.1% betamethasone sodium phosphate) that has widely been used for treatment of postoperative inflammation, uveitis, etc. as a steroid ophthalmic solution.

The secondary objective was to establish the evaluation system for a dose-finding study.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Anterior Uveitis
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
24
April 2001
Not Provided

Inclusion Criteria:

  • Patients with endogenous anterior uveitis (including panuveitis)
  • Patients with 20 or more anterior chamber cell within one field of the aqueous humor (Grade 3 or higher in clinical signs and grading) as measured with a slitlamp microscope
  • Patients aged ≥20 years and <75 years who could clearly express their subjective symptoms (Patients aged 20 years at giving informed consent were included in the study.)
  • 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 receiving systemic administration or topical administration to the head or face including instillation of corticosteroid, nonsteroidal anti-inflammatory drugs, antiphlogistic enzymes, immunosuppressive drugs or colchicines within 1 week before the initial instillation of the study drug
  • Patients with glaucoma or ocular hypertension (IOP ≥21 mmHg)
  • Patients with corneal erosion or corneal ulcer
  • Patients with viral keratoconjunctival diseases, tuberculos eye diseases, fungal eye diseases or bacterial eye diseases
  • Patients with diabetes mellitus
  • Patients with allergy to corticosteroids
  • Patients requiring use of contact lens during the study period
  • Women who were or might be pregnant
  • Patients participating in other clinical studies within 6 months before initiation of the present study
  • Patients with sensitivity to steroids(Patients who previously exhibited increased IOP after instillation of a steroid ophthalmic solution)
  • Patients with fibrins to such an extent that might affect measurement of flare
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00405496
SJE2079/2-02-PC
Not Provided
Not Provided
Sirion Therapeutics, Inc.
Not Provided
Study Chair: Kanjiro Masudo Director, Kanto Rosai Hospital
Sirion Therapeutics, Inc.
November 2006

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