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
  Purpose

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00405496

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

No publications provided

ClinicalTrials.gov 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:
Chorioretinitis
Iridocyclitis
Uveitis
Uveitis, Anterior
Choroid Diseases
Choroiditis
Eye Diseases
Iris Diseases
Panuveitis
Retinal Diseases
Retinitis
Uveal Diseases
Uveitis, Posterior
Difluprednate
Fluprednisolone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014