Safety and Efficacy of Difluprednate 0.05% for the Treatment of Anterior Uveitis
Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Endogenous Anterior Uveitis
Intervention: Difluprednate 0.05% ophthalmic emulsion (Drug); Prednisolone acetate 1.0% ophthalmic suspension (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Alcon Research
Summary
The purpose of this study was to demonstrate that difluprednate 0. 05% (Durezol) dosed 4
times daily is noninferior to prednisolone 1% (Pred Forte) dosed 8 times daily for the
treatment of endogenous anterior uveitis.
Clinical Details
Official title: A Phase 3 Multicenter, Randomized, Double-Masked Study of the Safety and Efficacy of Difluprednate 0.05% Ophthalmic Emulsion Compared to Prednisolone Acetate 1% Ophthalmic Suspension in the Treatment of Endogenous Anterior Uveitis
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14
Secondary outcome: Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points Proportion of Subjects With Anterior Chamber Cell Grade of 0 Proportion of Subjects With Anterior Chamber Cell Count of 0 Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0 Proportion of Subjects With Anterior Chamber Cell Grade ≤1 Proportion of Subjects Who Discontinued Due to Lack of Efficacy Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits
Eligibility
Minimum age: 2 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of endogenous anterior uveitis in at least 1 eye.
- The presence of > 10 cells in the anterior chamber of at least one eye, and a flare
score of > 2 in that same eye.
- Age 2 years or older on day of consent.
- Negative urine pregnancy test on Day 0 for females of childbearing potential who are
not at least 1 year post-menopausal or surgically sterilized.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Presence of endogenous anterior uveitis diagnosed for > 2 weeks prior to enrollment
in the study.
- Presence of intermediate uveitis, posterior uveitis or panuveitis in either eye.
- Instillation of any topical corticosteroid or NSAID in the study eye within 7 days of
instillation of study drug.
- History of glaucoma or clinically significant ocular hypertension in the opinion of
the Investigator involving an IOP ≥ 21 millimeters mercury in either eye.
- History of steroid-induced elevation of intraocular pressure.
- Any confirmed or suspected active viral, bacterial or fungal keratoconjunctival
disease in either eye.
- History of glaucoma or clinically significant ocular hypertension in the opinion of
the Investigator involving an intraocular pressure (IOP) > 21 mmHg in either eye.
- Corneal abrasion or ulceration in either eye.
- Pregnancy or lactation.
- Other protocol-defined exclusion criteria may apply.
Locations and Contacts
Contact Alcon Call Center, Fort Worth, Texas 76134, United States
Additional Information
Starting date: October 2010
Last updated: October 15, 2012
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