Back to resultsSafety and Efficacy of Difluprednate 0.05% for the Treatment of Anterior Uveitis
Primary Purpose
Endogenous Anterior Uveitis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Difluprednate 0.05% ophthalmic emulsion
Prednisolone acetate 1.0% ophthalmic suspension
Sponsored by
About this trial
This is an interventional treatment trial for 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.
Sites / Locations
- Contact Alcon Call Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Durezol
Pred Forte
Arm Description
Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01201798
Brief Title
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
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endogenous Anterior Uveitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Durezol
Arm Type
Experimental
Arm Description
Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
Arm Title
Pred Forte
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Difluprednate 0.05% ophthalmic emulsion
Other Intervention Name(s)
Durezol
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Prednisolone acetate 1.0% ophthalmic suspension
Other Intervention Name(s)
Pred Forte
Intervention Description
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
Primary Outcome Measure Information:
Title
Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14
Description
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
Secondary Outcome Measure Information:
Title
Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14
Description
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
Title
Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points
Description
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
Title
Proportion of Subjects With Anterior Chamber Cell Grade of 0
Description
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
Title
Proportion of Subjects With Anterior Chamber Cell Count of 0
Description
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.
Time Frame
Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42
Title
Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0
Description
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
Title
Proportion of Subjects With Anterior Chamber Cell Grade ≤1
Description
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
Title
Proportion of Subjects Who Discontinued Due to Lack of Efficacy
Description
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
Title
Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points
Description
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
Title
Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Contact Alcon Call Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24677110
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.
Results Reference
derived
Learn more about this trial
Safety and Efficacy of Difluprednate 0.05% for the Treatment of Anterior Uveitis
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