Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis

• Status: Completed
• Trial end date: 2003-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sirion Therapeutics, Inc.
• Treatments: Difluprednate; Fluprednisolone

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