Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis

NCT00405496 | Completed Phase 2

• 1 other identifier: SJE2079/2-02-PC
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this phase 2 study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of uveitis.

Conditions

Anterior Uveitis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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.

Interventions

Difluprednate Ophthalmic Emulsion DRUG

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sirion Therapeutics, Inc.: lead

MeSH Terms

Conditions

Uveitis, Anterior

Condition Hierarchy (Ancestors)

Panuveitis; Uveitis; Uveal Diseases; Eye Diseases

Study Officials

• Kanjiro Masudo

  Director, Kanto Rosai Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 29, 2006
• First Posted: November 30, 2006
• Study Start: March 1, 2000
• Study Completion: April 1, 2001
• Last Updated: November 30, 2006

Record last verified: 2006-11