Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis

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

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

Condition Intervention Phase
Anterior Uveitis
Drug: Difluprednate Ophthalmic Emulsion
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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).

Resource links provided by NLM:

Further study details as provided by Sirion Therapeutics, Inc.:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 24
Study Start Date: March 2000
Estimated Study Completion Date: April 2001
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.


Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its identifier: NCT00405496

Sponsors and Collaborators
Sirion Therapeutics, Inc.
Study Chair: Kanjiro Masudo Director, Kanto Rosai Hospital
  More Information

No publications provided Identifier: NCT00405496     History of Changes
Other Study ID Numbers: SJE2079/2-02-PC
Study First Received: November 29, 2006
Last Updated: November 29, 2006
Health Authority: Japan: Institutional Review Board

Additional relevant MeSH terms:
Uveitis, Anterior
Uveal Diseases
Eye Diseases
Retinal Diseases
Choroid Diseases
Uveitis, Posterior
Iris Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses processed this record on April 14, 2014