Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis

NCT00406887 | Completed Phase 3

• 1 other identifier: SJE2079/3-01-PC
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Anterior Uveitis; Panuveitis

Outcome Measures

Primary Outcomes (2)

• The difference from the baseline in anterior chamber cell score on Day 14

• was compared between the two groups.

Secondary Outcomes (8)

• 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

Interventions

Difluprednate Ophthalmic Emulsion DRUG

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sirion Therapeutics, Inc.: lead

MeSH Terms

Conditions

Uveitis, Anterior; Panuveitis

Condition Hierarchy (Ancestors)

Uveitis; Uveal Diseases; Eye Diseases

Study Officials

• Shigeaki Ohno, PhD

  Department of Ophthalmology and Visual Science, Graduate School of Medicine, Hokkaido University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 29, 2006
• First Posted: December 4, 2006
• Study Start: August 1, 2002
• Study Completion: November 1, 2003
• Last Updated: December 4, 2006

Record last verified: 2006-11