Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis

• Status: Completed
• Trial end date: 2001-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients who did not meet all of the above inclusion criteria

• 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