Study of Difluprednate Ophthalmic Emulsion in the Treatment of Severe Uveitis

• Status: Completed
• Trial end date: 2003-06-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

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

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

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

• 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