Study of Difluprednate Ophthalmic Emulsion in the Treatment of Severe Uveitis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Outcome Measures
Primary Outcome Measures
- The anterior chamber cell score was compared between baseline and Day 14. []
Secondary Outcome Measures
- The anterior chamber cell score was compared between baseline and Days 3 and 7. []
- 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, []
- ciliary hyperemia, keratic precipitate and synechia of iris and []
- posterior scores) were compared between baseline and Days 3, 7 []
- and 14. []
Eligibility Criteria
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)
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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)
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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
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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
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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)
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Patients receiving instillation of any corticosteroid, non-steroidal anti-inflammatory ophthalmic solution or antiphologistic enzyme within 12 hours before instillation of the investigational drug
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Patients with glaucoma or ocular hypertension
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Patients with corneal erosion or corneal ulcer
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Patients with any viral, bacterial or fungal keratoconjunctival disease or suspected with eye infection
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Patients with allergy to similar drugs of difluprednate
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Patients requiring use of contact lens during the study period
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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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sirion Therapeutics, Inc.
Investigators
- Principal Investigator: Shigeaki Ono, Department of Ophthalmology and Visual Science, Graduate School of Medicine, Hokkaido University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SJE2079/3-02-PC