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Study of Difluprednate Ophthalmic Emulsion in the Treatment of Severe Uveitis

This study has been completed.
Sponsor:
Information provided by:
Sirion Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00407056
First received: November 29, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
  Purpose

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
Uveitis
Panuveitis
 Drug: Difluprednate Ophthalmic Emulsion
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00407056

Sponsors and Collaborators
Sirion Therapeutics, Inc.
Investigators
Principal Investigator: Shigeaki Ono Department of Ophthalmology and Visual Science, Graduate School of Medicine, Hokkaido University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00407056     History of Changes
Other Study ID Numbers: SJE2079/3-02-PC
Study First Received: November 29, 2006
Last Updated: November 29, 2006
Health Authority: Japan: Institutional Review Board

Additional relevant MeSH terms:
Panuveitis
Uveitis
Chorioretinitis
Uveal Diseases
Eye Diseases
Retinitis
Retinal Diseases
Choroiditis
Choroid Diseases
Uveitis, Posterior
 Difluprednate
Fluprednisolone
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013