Panuveitis Clinical Trial
Official title:
Phase 3 Confirmatory Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of 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 confirmatory study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of treatment of uveitis.
Status | Completed |
Enrollment | 140 |
Est. completion date | November 2003 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sirion Therapeutics, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The difference from the baseline in anterior chamber cell score on Day 14 | |||
Primary | was compared between the two groups. | |||
Secondary | The differences from the baseline in anterior chamber cell score on Days 3 and 7 | |||
Secondary | were compared between the two groups. | |||
Secondary | The numbers of patients with an anterior chamber cell score of 0 on Days 7 and | |||
Secondary | 14 were compared between the two groups. | |||
Secondary | The differences from the baseline in total sign and symptom scores on Days 3, 7 | |||
Secondary | and 14 were compared between the two groups. | |||
Secondary | The numbers of patients with an anterior chamber cell score of 1 or less on Days | |||
Secondary | 3, 7 and 14 were compared between the two groups. |
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