Anterior Uveitis, Panuveitis
Conditions
Brief 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.
Detailed description
The objective of this phase 3 study is to assess the efficacy and safety of 0.05% difluprednate ophthalmic emulsion (DFBA) in patients with endogenous anterior uveitis, in comparison with 0.1% betamethasone sodium phosphate ophthalmic solution (BP).
Interventions
Sponsors
Sirion Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference from the baseline in anterior chamber cell score on Day 14 | — |
| was compared between the two groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| The numbers of patients with an anterior chamber cell score of 0 on Days 7 and | — |
| 14 were compared between the two groups. | — |
| The differences from the baseline in total sign and symptom scores on Days 3, 7 | — |
| The differences from the baseline in anterior chamber cell score on Days 3 and 7 | — |
| The numbers of patients with an anterior chamber cell score of 1 or less on Days | — |
| 3, 7 and 14 were compared between the two groups. | — |
| and 14 were compared between the two groups. | — |
| were compared between the two groups. | — |
Outcome results
None listed