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Trial record 3 of 6 for:    Durezol | Uveitis

Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00405496
Recruitment Status : Completed
First Posted : November 30, 2006
Last Update Posted : November 30, 2006
Information provided by:
Sirion Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Anterior Uveitis Drug: Difluprednate Ophthalmic Emulsion Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Phase 2a Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Anterior Uveitis (Inluding Iritis, Cyclitis, Iridocyclitis, and Panuveitis).
Study Start Date : March 2000
Study Completion Date : April 2001

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. The anterior chamber cell score was compared between baseline and after completion of the
  2. study treatment (14 +/- 2 days). The efficacy was evaluated with a 4-point scale based on the
  3. reduction of anterior chamber cell.

Secondary Outcome Measures :
  1. The overall efficacy was evaluated with a 4-point-scale based on the change in the flare value
  2. (baseline/after completion of the study treatment ratio), as measured with a laser flare cell
  3. meter, and those in anterior chamber flare as measured with a slitlamp microscope and clinical
  4. signs and symptoms after completion of the study treatment (142 days) from baseline.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00405496

Sponsors and Collaborators
Sirion Therapeutics, Inc.
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Study Chair: Kanjiro Masudo Director, Kanto Rosai Hospital
Layout table for additonal information Identifier: NCT00405496    
Other Study ID Numbers: SJE2079/2-02-PC
First Posted: November 30, 2006    Key Record Dates
Last Update Posted: November 30, 2006
Last Verified: November 2006
Additional relevant MeSH terms:
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Uveitis, Anterior
Uveal Diseases
Eye Diseases
Iris Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs