Clinical trial NCT01201798: Safety and Efficacy of Difluprednate 0.05% for the Treatment of Anterior Uveitis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Endogenous Anterior Uveitis
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-09-15
Enrollment: 111
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14
timeFrame: Baseline (Day 0), Day 14
Secondary outcomes:
measure: Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14
timeFrame: Baseline (Day 0), Day 3, Day 7, Day 21, Day 28, Day 35, Day 42
measure: Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points
timeFrame: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42
measure: Proportion of Subjects With Anterior Chamber Cell Grade of 0
timeFrame: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42
measure: Proportion of Subjects With Anterior Chamber Cell Count of 0
timeFrame: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42
measure: Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0
timeFrame: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42
measure: Proportion of Subjects With Anterior Chamber Cell Grade ≤1
timeFrame: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42
measure: Proportion of Subjects Who Discontinued Due to Lack of Efficacy
timeFrame: Time to Event
measure: Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points
timeFrame: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42
measure: Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits
timeFrame: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center
state: Texas
Study officials:
References:
citation: Sheppard JD, Toyos MM, Kempen JH, Kaur P, Foster CS. Difluprednate 0.05% versus prednisolone acetate 1% for endogenous anterior uveitis: a phase III, multicenter, randomized study. Invest Ophthalmol Vis Sci. 2014 May 6;55(5):2993-3002. doi: 10.1167/iovs.13-12660.