Anterior Uveitis
Conditions
Brief summary
The purpose of this phase 2 study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of uveitis.
Detailed 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.
Interventions
Sponsors
Sirion Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The anterior chamber cell score was compared between baseline and after completion of the | — |
| study treatment (14 +/- 2 days). The efficacy was evaluated with a 4-point scale based on the | — |
| reduction of anterior chamber cell. | — |
Secondary
| Measure | Time frame |
|---|---|
| The overall efficacy was evaluated with a 4-point-scale based on the change in the flare value | — |
| signs and symptoms after completion of the study treatment (142 days) from baseline. | — |
| (baseline/after completion of the study treatment ratio), as measured with a laser flare cell | — |
| meter, and those in anterior chamber flare as measured with a slitlamp microscope and clinical | — |
Outcome results
None listed