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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
111
1 drop in study eye, 4 times a day, for 14 days, followed by a 14-day tapering period dependent on the Investigator's determination of adequate response to treatment
1 drop in study eye, 8 times a day, for 14 days, followed by a 14-day tapering period dependent on the Investigator's determination of adequate response to treatment
Contact Alcon Call Center
Fort Worth, Texas, United States
Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14
Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = \> 50 cell count.
Time frame: Baseline (Day 0), Day 14
Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14
Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = \> 50 cell count.
Time frame: Baseline (Day 0), Day 3, Day 7, Day 21, Day 28, Day 35, Day 42
Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points
Anterior chamber flare (protein escaping from dialated vessels) was assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = none; 1 = mild (trace to clearly noticeable, visible); 2 = moderate; 3 = marked; and 4 = severe.
Time frame: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42
Proportion of Subjects With Anterior Chamber Cell Grade of 0
Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = \> 50 cell count. Proportion is reported as percentage of subjects.
Time frame: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42
Proportion of Subjects With Anterior Chamber Cell Count of 0
Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and recorded based on actual cell count. Proportion is reported as a percentage of subjects.
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Time frame: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42
Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0
Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and recorded based on actual cell count. Anterior chamber flare (protein escaping from dialated vessels) was assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = none; 1 = mild (trace to clearly noticeable, visible); 2 = moderate; 3 = marked; and 4 = severe. Proportion is reported as percentage of subjects.
Time frame: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42
Proportion of Subjects With Anterior Chamber Cell Grade ≤1
As assessed by the investigator during slit lamp examination. Anterior chamber cell grade was graded on a 5-point scale, with 0 = no cells; 1 = 1 to 10 cells; 2 = 11 to 20 cells; 3 = 21 to 50 cells; and 4 = more than 50 cells. Proportion is reported as percentage of subjects.
Time frame: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42
Proportion of Subjects Who Discontinued Due to Lack of Efficacy
Lack of efficacy was defined as those subjects who discontinued study participation either due to treatment failure or an adverse event with a preferred term of iridocyclitis, iritis, uveitis, or vitritis. Proportion is reported as percentage of subjects.
Time frame: Time to Event
Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points
The following symptoms were each graded by the subject according to a 0-100 visual analog scale (VAS) using a mark on a 100 mm line (0 = absent, 100 = maximal): eye pain, photophobia, blurred vision, and lacrimation. The total symptom score was calculated as the sum of the 4 individual symptom scores.
Time frame: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42
Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits
The following signs were each graded on a 0 - 3 scale (0 = absent; 1 = mild; 2 = moderate; 3 = severe): posterior synechia, hypopyon, limbal injection, and keratic precipitates. Peripheral synechia was graded by the combined number of clock hours affected (0 = absent; 1 = \< 3 hrs; 2 = 3-6 hours; 3 = \> 6 hours). The total sign score was calculated as the sum of the 5 individual sign scores, the anterior chamber cell grade and the anterior chamber flare grade. The minimum/best total sign score was 0, and the maximum/worst total sign score was 23.
Time frame: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42