Endogenous Anterior Uveitis
Conditions
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.
Interventions
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
DRUGPrednisolone acetate 1.0% ophthalmic suspension
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
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 21 US study sites.
Pre-assignment details
This reporting group includes all randomized subjects: 110. One subject was enrolled but discontinued prior to receiving study medication, with treatment randomization unknown.
Participants by arm
| Arm | Count |
|---|---|
| Durezol Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period | 56 |
| Pred Forte 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 | 54 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Decision Unrelated to an Adverse Event | 1 | 1 |
| Overall Study | Lost to Follow-up | 3 | 5 |
| Overall Study | Noncompliance | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Treatment Failure | 1 | 8 |
Baseline characteristics
| Characteristic | Durezol | Pred Forte | Total |
|---|---|---|---|
| Age Continuous | 49.8 years STANDARD_DEVIATION 15.2 | 45.5 years STANDARD_DEVIATION 18.29 | 47.7 years STANDARD_DEVIATION 16.85 |
| Sex: Female, Male Female | 31 Participants | 29 Participants | 60 Participants |
| Sex: Female, Male Male | 25 Participants | 25 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 14 / 56 | 8 / 54 |
| serious Total, serious adverse events | 2 / 56 | 0 / 54 |
Outcome results
Primary
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
Population: Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Durezol | Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14 | Baseline (Day 0) | 2.6 Units on a scale | Standard Deviation 0.68 |
| Durezol | Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14 | Day 14 | -2.2 Units on a scale | Standard Deviation 0.96 |
| Pred Forte | Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14 | Baseline (Day 0) | 2.6 Units on a scale | Standard Deviation 0.68 |
| Pred Forte | Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14 | Day 14 | -2.0 Units on a scale | Standard Deviation 1 |
Comparison: A two-tailed 95% confidence interval was calculated for the difference in change from baseline in anterior chamber cell grade at Day 14 (difluprednate minus prednisolone). The confidence interval was derived from an analysis of covariance (ANCOVA), with investigative site included as a fixed effect to match the stratification used in the randomization process. Treatment and baseline anterior chamber cell grade were also included as fixed effects.95% CI: [-0.53, 0.09]ANCOVA
Secondary
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
Population: Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Durezol | Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14 | Day 7 | -1.8 Units on a scale | Standard Deviation 0.77 |
| Durezol | Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14 | Day 28 | -2.3 Units on a scale | Standard Deviation 0.95 |
| Durezol | Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14 | Day 3 | -1.1 Units on a scale | Standard Deviation 0.95 |
| Durezol | Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14 | Day 35 | -2.3 Units on a scale | Standard Deviation 0.94 |
| Durezol | Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14 | Day 21 | -2.4 Units on a scale | Standard Deviation 0.98 |
| Durezol | Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14 | Day 42 | -2.3 Units on a scale | Standard Deviation 1 |
| Durezol | Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14 | Baseline (Day 0) | 2.6 Units on a scale | Standard Deviation 0.68 |
| Pred Forte | Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14 | Day 42 | -2.1 Units on a scale | Standard Deviation 1.01 |
| Pred Forte | Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14 | Baseline (Day 0) | 2.6 Units on a scale | Standard Deviation 0.68 |
| Pred Forte | Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14 | Day 3 | -1.0 Units on a scale | Standard Deviation 0.86 |
| Pred Forte | Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14 | Day 7 | -1.6 Units on a scale | Standard Deviation 0.85 |
| Pred Forte | Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14 | Day 21 | -2.1 Units on a scale | Standard Deviation 0.8 |
| Pred Forte | Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14 | Day 28 | -2.1 Units on a scale | Standard Deviation 0.95 |
| Pred Forte | Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14 | Day 35 | -2.1 Units on a scale | Standard Deviation 1.04 |
Secondary
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
Population: Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Durezol | Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points | Baseline (Day 0) | 2.2 Units on a scale | Standard Deviation 0.48 |
| Durezol | Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points | Day 3 | -1.1 Units on a scale | Standard Deviation 0.83 |
| Durezol | Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points | Day 7 | -1.6 Units on a scale | Standard Deviation 0.77 |
| Durezol | Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points | Day 14 | -2.0 Units on a scale | Standard Deviation 0.75 |
| Durezol | Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points | Day 21 | -2.0 Units on a scale | Standard Deviation 0.77 |
| Durezol | Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points | Day 28 | -2.0 Units on a scale | Standard Deviation 0.76 |
| Durezol | Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points | Day 35 | -2.0 Units on a scale | Standard Deviation 0.77 |
| Durezol | Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points | Day 42 | -2.0 Units on a scale | Standard Deviation 0.77 |
| Pred Forte | Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points | Day 42 | -2.0 Units on a scale | Standard Deviation 0.82 |
| Pred Forte | Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points | Baseline (Day 0) | 2.3 Units on a scale | Standard Deviation 0.54 |
| Pred Forte | Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points | Day 21 | -2.0 Units on a scale | Standard Deviation 0.78 |
| Pred Forte | Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points | Day 3 | -1.2 Units on a scale | Standard Deviation 1.07 |
| Pred Forte | Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points | Day 35 | -2.0 Units on a scale | Standard Deviation 0.83 |
| Pred Forte | Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points | Day 7 | -1.6 Units on a scale | Standard Deviation 0.95 |
| Pred Forte | Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points | Day 28 | -2.0 Units on a scale | Standard Deviation 0.79 |
| Pred Forte | Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points | Day 14 | -1.9 Units on a scale | Standard Deviation 0.91 |
Secondary
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
Population: Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Durezol | Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits | Day 14 | -6.1 Units on a scale | Standard Deviation 2.81 |
| Durezol | Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits | Day 3 | -3.5 Units on a scale | Standard Deviation 2.71 |
| Durezol | Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits | Day 21 | -6.5 Units on a scale | Standard Deviation 3.07 |
| Durezol | Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits | Day 35 | -6.3 Units on a scale | Standard Deviation 2.98 |
| Durezol | Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits | Day 28 | -6.4 Units on a scale | Standard Deviation 2.96 |
| Durezol | Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits | Day 7 | -5.2 Units on a scale | Standard Deviation 2.31 |
| Durezol | Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits | Day 42 | -6.2 Units on a scale | Standard Deviation 3.21 |
| Durezol | Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits | Baseline (Day 0) | 7.1 Units on a scale | Standard Deviation 2.71 |
| Pred Forte | Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits | Day 42 | -6.3 Units on a scale | Standard Deviation 3.27 |
| Pred Forte | Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits | Day 35 | -6.2 Units on a scale | Standard Deviation 3.34 |
| Pred Forte | Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits | Day 3 | -3.6 Units on a scale | Standard Deviation 2.95 |
| Pred Forte | Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits | Day 7 | -5.0 Units on a scale | Standard Deviation 3.05 |
| Pred Forte | Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits | Day 14 | -5.8 Units on a scale | Standard Deviation 3.34 |
| Pred Forte | Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits | Day 21 | -6.2 Units on a scale | Standard Deviation 3.04 |
| Pred Forte | Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits | Day 28 | -6.2 Units on a scale | Standard Deviation 3.18 |
| Pred Forte | Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits | Baseline (Day 0) | 7.3 Units on a scale | Standard Deviation 2.87 |
Secondary
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
Population: Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Durezol | Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points | Baseline (Day 0) | 186.7 Units on a scale | Standard Deviation 112.6 |
| Durezol | Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points | Day 21 | -138.8 Units on a scale | Standard Deviation 112.7 |
| Durezol | Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points | Day 28 | -140.1 Units on a scale | Standard Deviation 111.4 |
| Durezol | Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points | Day 7 | -108.2 Units on a scale | Standard Deviation 114.2 |
| Durezol | Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points | Day 35 | -143.9 Units on a scale | Standard Deviation 111 |
| Durezol | Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points | Day 3 | -88.4 Units on a scale | Standard Deviation 92.55 |
| Durezol | Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points | Day 42 | -146.2 Units on a scale | Standard Deviation 111.7 |
| Durezol | Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points | Day 14 | -133.3 Units on a scale | Standard Deviation 109.3 |
| Pred Forte | Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points | Day 42 | -155.5 Units on a scale | Standard Deviation 112.1 |
| Pred Forte | Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points | Baseline (Day 0) | 203.2 Units on a scale | Standard Deviation 110.8 |
| Pred Forte | Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points | Day 3 | -88.4 Units on a scale | Standard Deviation 92.71 |
| Pred Forte | Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points | Day 7 | -123.8 Units on a scale | Standard Deviation 100.4 |
| Pred Forte | Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points | Day 14 | -137.4 Units on a scale | Standard Deviation 108.8 |
| Pred Forte | Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points | Day 28 | -152.4 Units on a scale | Standard Deviation 115.9 |
| Pred Forte | Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points | Day 35 | -147.3 Units on a scale | Standard Deviation 111.3 |
| Pred Forte | Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points | Day 21 | -149.5 Units on a scale | Standard Deviation 108 |
Secondary
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
Population: Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Durezol | Proportion of Subjects Who Discontinued Due to Lack of Efficacy | 0 Percentage of subjects |
| Pred Forte | Proportion of Subjects Who Discontinued Due to Lack of Efficacy | 14.9 Percentage of subjects |
Secondary
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
Population: Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Durezol | Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0 | Day 42 | 80.4 Percentage of subjects |
| Durezol | Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0 | Day 7 | 41.3 Percentage of subjects |
| Durezol | Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0 | Day 14 | 78.3 Percentage of subjects |
| Durezol | Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0 | Day 21 | 82.6 Percentage of subjects |
| Durezol | Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0 | Day 28 | 80.4 Percentage of subjects |
| Durezol | Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0 | Day 35 | 82.6 Percentage of subjects |
| Durezol | Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0 | Day 3 | 13.0 Percentage of subjects |
| Pred Forte | Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0 | Day 28 | 76.6 Percentage of subjects |
| Pred Forte | Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0 | Day 3 | 14.9 Percentage of subjects |
| Pred Forte | Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0 | Day 21 | 76.6 Percentage of subjects |
| Pred Forte | Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0 | Day 7 | 40.4 Percentage of subjects |
| Pred Forte | Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0 | Day 42 | 78.7 Percentage of subjects |
| Pred Forte | Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0 | Day 35 | 76.6 Percentage of subjects |
| Pred Forte | Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0 | Day 14 | 61.7 Percentage of subjects |
Secondary
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.
Time frame: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42
Population: Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Durezol | Proportion of Subjects With Anterior Chamber Cell Count of 0 | Day 42 | 69.6 Percentage of subjects |
| Durezol | Proportion of Subjects With Anterior Chamber Cell Count of 0 | Day 3 | 13.0 Percentage of subjects |
| Durezol | Proportion of Subjects With Anterior Chamber Cell Count of 0 | Day 7 | 21.7 Percentage of subjects |
| Durezol | Proportion of Subjects With Anterior Chamber Cell Count of 0 | Day 14 | 52.2 Percentage of subjects |
| Durezol | Proportion of Subjects With Anterior Chamber Cell Count of 0 | Day 21 | 73.9 Percentage of subjects |
| Durezol | Proportion of Subjects With Anterior Chamber Cell Count of 0 | Day 28 | 73.9 Percentage of subjects |
| Durezol | Proportion of Subjects With Anterior Chamber Cell Count of 0 | Day 35 | 69.6 Percentage of subjects |
| Pred Forte | Proportion of Subjects With Anterior Chamber Cell Count of 0 | Day 21 | 48.9 Percentage of subjects |
| Pred Forte | Proportion of Subjects With Anterior Chamber Cell Count of 0 | Day 42 | 68.1 Percentage of subjects |
| Pred Forte | Proportion of Subjects With Anterior Chamber Cell Count of 0 | Day 35 | 63.8 Percentage of subjects |
| Pred Forte | Proportion of Subjects With Anterior Chamber Cell Count of 0 | Day 14 | 38.3 Percentage of subjects |
| Pred Forte | Proportion of Subjects With Anterior Chamber Cell Count of 0 | Day 3 | 2.1 Percentage of subjects |
| Pred Forte | Proportion of Subjects With Anterior Chamber Cell Count of 0 | Day 28 | 63.8 Percentage of subjects |
| Pred Forte | Proportion of Subjects With Anterior Chamber Cell Count of 0 | Day 7 | 21.3 Percentage of subjects |
Secondary
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
Population: Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Durezol | Proportion of Subjects With Anterior Chamber Cell Grade ≤1 | Day 35 | 93.5 Percentage of subjects |
| Durezol | Proportion of Subjects With Anterior Chamber Cell Grade ≤1 | Day 42 | 91.3 Percentage of subjects |
| Durezol | Proportion of Subjects With Anterior Chamber Cell Grade ≤1 | Day 3 | 50.0 Percentage of subjects |
| Durezol | Proportion of Subjects With Anterior Chamber Cell Grade ≤1 | Day 7 | 87.0 Percentage of subjects |
| Durezol | Proportion of Subjects With Anterior Chamber Cell Grade ≤1 | Day 14 | 93.5 Percentage of subjects |
| Durezol | Proportion of Subjects With Anterior Chamber Cell Grade ≤1 | Day 21 | 93.5 Percentage of subjects |
| Durezol | Proportion of Subjects With Anterior Chamber Cell Grade ≤1 | Day 28 | 93.5 Percentage of subjects |
| Pred Forte | Proportion of Subjects With Anterior Chamber Cell Grade ≤1 | Day 42 | 85.1 Percentage of subjects |
| Pred Forte | Proportion of Subjects With Anterior Chamber Cell Grade ≤1 | Day 35 | 85.1 Percentage of subjects |
| Pred Forte | Proportion of Subjects With Anterior Chamber Cell Grade ≤1 | Day 14 | 85.1 Percentage of subjects |
| Pred Forte | Proportion of Subjects With Anterior Chamber Cell Grade ≤1 | Day 28 | 87.2 Percentage of subjects |
| Pred Forte | Proportion of Subjects With Anterior Chamber Cell Grade ≤1 | Day 3 | 57.4 Percentage of subjects |
| Pred Forte | Proportion of Subjects With Anterior Chamber Cell Grade ≤1 | Day 21 | 89.4 Percentage of subjects |
| Pred Forte | Proportion of Subjects With Anterior Chamber Cell Grade ≤1 | Day 7 | 80.9 Percentage of subjects |
Secondary
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
Population: Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Durezol | Proportion of Subjects With Anterior Chamber Cell Grade of 0 | Day 14 | 65.2 Percentage of subjects |
| Durezol | Proportion of Subjects With Anterior Chamber Cell Grade of 0 | Day 28 | 80.4 Percentage of subjects |
| Durezol | Proportion of Subjects With Anterior Chamber Cell Grade of 0 | Day 7 | 34.8 Percentage of subjects |
| Durezol | Proportion of Subjects With Anterior Chamber Cell Grade of 0 | Day 35 | 78.3 Percentage of subjects |
| Durezol | Proportion of Subjects With Anterior Chamber Cell Grade of 0 | Day 21 | 84.8 Percentage of subjects |
| Durezol | Proportion of Subjects With Anterior Chamber Cell Grade of 0 | Day 42 | 76.1 Percentage of subjects |
| Durezol | Proportion of Subjects With Anterior Chamber Cell Grade of 0 | Day 3 | 15.2 Percentage of subjects |
| Pred Forte | Proportion of Subjects With Anterior Chamber Cell Grade of 0 | Day 42 | 74.5 Percentage of subjects |
| Pred Forte | Proportion of Subjects With Anterior Chamber Cell Grade of 0 | Day 3 | 6.4 Percentage of subjects |
| Pred Forte | Proportion of Subjects With Anterior Chamber Cell Grade of 0 | Day 7 | 25.5 Percentage of subjects |
| Pred Forte | Proportion of Subjects With Anterior Chamber Cell Grade of 0 | Day 14 | 55.3 Percentage of subjects |
| Pred Forte | Proportion of Subjects With Anterior Chamber Cell Grade of 0 | Day 21 | 63.8 Percentage of subjects |
| Pred Forte | Proportion of Subjects With Anterior Chamber Cell Grade of 0 | Day 28 | 70.2 Percentage of subjects |
| Pred Forte | Proportion of Subjects With Anterior Chamber Cell Grade of 0 | Day 35 | 70.2 Percentage of subjects |