Panuveitis, Uveitis
Conditions
Brief 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.
Detailed description
The objective of this phase 3 study is to assess the efficacy and safety of 0.05% difluprednate ophthalmic emulsion in patients with severe endogenous anterior uveitis with an open-labeled, no-controlled and no-randomized design.
Interventions
Sponsors
Sirion Therapeutics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The anterior chamber cell score was compared between baseline and Day 14. | — |
Secondary
| Measure | Time frame |
|---|---|
| The total symptom score (sum of eye pain, photophobia, blurred | — |
| vision, foreign body sensation and lacrimation scores) and total | — |
| sign score (sum of anterior chamber cell, anterior chamber flare, | — |
| The anterior chamber cell score was compared between baseline and Days 3 and 7. | — |
| posterior scores) were compared between baseline and Days 3, 7 | — |
| and 14. | — |
| ciliary hyperemia, keratic precipitate and synechia of iris and | — |
Outcome results
None listed