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Study of Difluprednate Ophthalmic Emulsion in the Treatment of Severe 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 3 open-labeled study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of severe uveitis.

Condition Intervention Phase
Drug: Difluprednate Ophthalmic Emulsion
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 3 Open-Labeled Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Severe Anterior Uveitis (Including 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 Day 14.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 20
Study Start Date: August 2002
Estimated Study Completion Date: June 2003
Detailed Description:
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.

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00407056

Sponsors and Collaborators
Sirion Therapeutics, Inc.
Principal Investigator: Shigeaki Ono Department of Ophthalmology and Visual Science, Graduate School of Medicine, Hokkaido University
  More Information Identifier: NCT00407056     History of Changes
Other Study ID Numbers: SJE2079/3-02-PC
Study First Received: November 29, 2006
Last Updated: November 29, 2006

Additional relevant MeSH terms:
Uveal Diseases
Eye Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents processed this record on May 25, 2017