Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis

Sirion Therapeutics

Status and phase

Completed

Phase 2

Conditions

Anterior Uveitis

Treatments

Drug: Difluprednate Ophthalmic Emulsion

Study type

Interventional

Funder types

Industry

Identifiers

NCT00405496

SJE2079/2-02-PC

Details and patient eligibility

About

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

Full description

The primary objective was to investigate the efficacy and safety of 0.05% difluprednate ophthalmic emulsion in patients with endogenous anterior uveitis and to determine its clinical usefulness for treatment of this disease in the early phase of development, in comparison with Rinderon® solution (containing 0.1% betamethasone sodium phosphate) that has widely been used for treatment of postoperative inflammation, uveitis, etc. as a steroid ophthalmic solution.

The secondary objective was to establish the evaluation system for a dose-finding study.

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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