Uveitis Clinical Trial
Official title:
Phase 3 Open-Labeled Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Severe Anterior Uveitis (Including Panuveitis).
Verified date | November 2006 |
Source | Sirion Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Institutional Review Board |
Study type | Interventional |
The purpose of this phase 3 open-labeled study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of severe uveitis.
Status | Completed |
Enrollment | 20 |
Est. completion date | June 2003 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sirion Therapeutics, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The anterior chamber cell score was compared between baseline and Day 14. | |||
Secondary | The anterior chamber cell score was compared between baseline and Days 3 and 7. | |||
Secondary | The total symptom score (sum of eye pain, photophobia, blurred | |||
Secondary | vision, foreign body sensation and lacrimation scores) and total | |||
Secondary | sign score (sum of anterior chamber cell, anterior chamber flare, | |||
Secondary | ciliary hyperemia, keratic precipitate and synechia of iris and | |||
Secondary | posterior scores) were compared between baseline and Days 3, 7 | |||
Secondary | and 14. |
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