Safety and Efficacy of Difluprednate 0.05% for the Treatment of Anterior Uveitis
- Conditions
- Endogenous Anterior Uveitis
- Interventions
- Registration Number
- NCT01201798
- Lead Sponsor
- Alcon Research
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 111
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Durezol Difluprednate 0.05% ophthalmic emulsion Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period Pred Forte Prednisolone acetate 1.0% ophthalmic suspension Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
- Primary Outcome Measures
Name Time Method Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14 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 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 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 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 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 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 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 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 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.
Trial Locations
- Locations (1)
Contact Alcon Call Center
🇺🇸Fort Worth, Texas, United States