Study of Difluprednate Ophthalmic Emulsion in the Treatment of Severe Uveitis

NCT00407056 | Completed Phase 3

• 1 other identifier: SJE2079/3-02-PC
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Uveitis; Panuveitis

Outcome Measures

Primary Outcomes (1)

• The anterior chamber cell score was compared between baseline and Day 14.

Secondary Outcomes (7)

• 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

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sirion Therapeutics, Inc.: lead

MeSH Terms

Conditions

Uveitis; Panuveitis

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Study Officials

• Shigeaki Ono

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

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

Record last verified: 2006-11