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:
NCT00406887
First received: November 29, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
  Purpose

The purpose of this phase 3 confirmatory study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of treatment of uveitis.


Condition Intervention Phase
Anterior Uveitis
Panuveitis
Drug: Difluprednate Ophthalmic Emulsion
Phase 3

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 3 Confirmatory Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Anterior Uveitis (Including Panuveitis).

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The difference from the baseline in anterior chamber cell score on Day 14
  • was compared between the two groups.

Secondary Outcome Measures:
  • The differences from the baseline in anterior chamber cell score on Days 3 and 7
  • were compared between the two groups.
  • The numbers of patients with an anterior chamber cell score of 0 on Days 7 and
  • 14 were compared between the two groups.
  • The differences from the baseline in total sign and symptom scores on Days 3, 7
  • and 14 were compared between the two groups.
  • The numbers of patients with an anterior chamber cell score of 1 or less on Days
  • 3, 7 and 14 were compared between the two groups.

Estimated Enrollment: 140
Study Start Date: August 2002
Estimated Study Completion Date: November 2003
Detailed Description:

The objective of this phase 3 study is to assess the efficacy and safety of 0.05% difluprednate ophthalmic emulsion (DFBA) in patients with endogenous anterior uveitis, in comparison with 0.1% betamethasone sodium phosphate ophthalmic solution (BP).

  Eligibility

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

Inclusion Criteria:

  • Patients diagnosed with endogenous anterior uveitis or panuveitis
  • Patients with 10 - 49 anterior chamber cells within one field of the anterior chamber as observed by slit lamp microscopy (criterion for rating of signs 2 or 3)
  • Patients aged ‰1425 years (on the day of obtaining informed consent) who were able to accurately express their own symptoms
  • Patients provided written informed consent prior to initiation of the study

Exclusion Criteria:

  • Patients who did not meet all of the above inclusion criteria
  • Patients received systemic administration of any corticosteroid or immunosuppressive drug within the past 1 week prior to instillation of the investigational product
  • Patients received topical injection of any corticosteroid in eyes prior to instillation of the investigational product (Solution formulation: within the past 1 week, depot: within the past 2 weeks)
  • Patients received systemic administration of any non-steroidal anti-inflammatory drug or antiphlogistic enzyme within the past 3 days prior to instillation of the investigational product
  • Patients received instillation of any corticosteroid, non-steroidal anti-inflammatory drug or antiphlogistic enzyme within 12 hours prior to instillation of the investigational product
  • Patients with glaucoma or ocular hypertension
  • Patients with corneal abrasion or ulcer
  • Patients with any confirmed or suspected viral, bacterial or fungal keratoconjunctival disease
  • Patients with allergy to similar drugs such as other corticosteroids
  • Patients requiring use of contact lens during the study period
  • Women who are or might be pregnant, or lactating women
  • Patients participating in another clinical study within the past 3 months before initiation of the present study
  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: NCT00406887

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

No publications provided

ClinicalTrials.gov Identifier: NCT00406887     History of Changes
Other Study ID Numbers: SJE2079/3-01-PC
Study First Received: November 29, 2006
Last Updated: November 29, 2006
Health Authority: Japan: Institutional Review Board

Additional relevant MeSH terms:
Uveitis
Chorioretinitis
Panuveitis
Uveitis, Anterior
Iridocyclitis
Uveal Diseases
Eye Diseases
Retinitis
Retinal Diseases
Choroiditis
Choroid Diseases
Uveitis, Posterior
Iris Diseases
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 September 18, 2014