Clinical Trial: Safety and Efficacy of Difluprednate 0.05% for the Treatment of Anterior Uveitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Alcon Research

Current Primary Outcome: Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14 [ Time Frame: Baseline (Day 0), 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.


Original Primary Outcome: Change from baseline in anterior chamber cell grade [ Time Frame: Change from baseline at Day 14 ]

Current Secondary Outcome:

  • Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14 [ Time Frame: Baseline (Day 0), Day 3, Day 7, Day 21, Day 28, Day 35, Day 42 ]
    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.
  • Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points [ Time Frame: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 ]
    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 of Subjects With Anterior Chamber Cell Grade of 0 [ Time Frame: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 ]
    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.
  • Proportion of Subjects With Anterior Chamber Cell Count of 0 [ Time Frame: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 ]
    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.
  • Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0 [ Time Frame: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 ]
    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.
  • Proportion of Subjects With Anterior Chamber Cell Grade ≤1 [ Time Frame: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 ]
    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.
  • Proportion of Subjects Who Discontinued Due to Lack of Efficacy [ Time Frame: Time to Event ]
    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.
  • Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points [ Time Frame: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 ]
    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.
  • Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits [ Time Frame: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 ]
    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.


Original Secondary Outcome:

  • Anterior chamber flare [ Time Frame: Change from baseline at Day 14 ]
  • Total sign score [ Time Frame: Change from baseline at Day 14 ]


Information By: Alcon Research

Dates:
Date Received: September 13, 2010
Date Started: October 2010
Date Completion:
Last Updated: October 15, 2012
Last Verified: October 2012