Cataracts, Inflammation
Conditions
Keywords
Pediatric, Cataracts, Inflammation, Durezol, Pred Forte, Difluprednate, Prednisolone
Brief summary
The primary objective of this study was to compare the safety and efficacy of Durezol™ compared to Pred Forte™ for the treatment of inflammation following cataract surgery in a pediatric population 0 to 3 years of age.
Detailed description
Parents or guardians instilled patients' assigned study medications once on the day of surgery (Day 0) and 4 times daily (QID) beginning on the day after surgery (Day 1) for 14 days followed by a tapering period of 14 days (dependent upon the Investigator's determination of adequate response to treatment). Patients were evaluated for safety and efficacy on the following visits: Day 0 (day of surgery), Day 1, Day 8 ± 1 day, Day 15 ± 2 days and Day 29 ± 2 days (end of study drug treatment). Additional safety visits occurred at 1 week after the last dose + 2 days and at 3 Months + 1 week. No inferential statistical analysis was planned for this study. Data was summarized using descriptive statistics.
Interventions
DRUGDifluprednate ophthalmic emulsion, 0.05%
Topical ocular administration
DRUGPrednisolone acetate ophthalmic suspension, 1.0%
Topical ocular administration
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Years
Healthy volunteers
No
Inclusion criteria
* 0 to 3 years of age. * Undergoing uncomplicated cataract extraction in 1 eye with or without intraocular lens. * Informed consent signed by a parent or legal guardian. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Presence of any active or suspected viral, bacterial, or fungal disease in the study eye. * Use of any topical medication in the study within 7 days prior to surgery, except for drops that are needed to examine the eye or to prepare for surgery. * Patients with posttraumatic cataract. * Active uveitis in the study eye. * Ocular neoplasm in the study eye. * Human immunodeficiency virus (HIV); acquired immunodeficiency syndrome (AIDS). * Suspected permanent low vision or blindness in the fellow nonstudy eye. The study eye must not be the patient's only good eye. * Patients on systemic steroids or nonsteroidal anti-inflammatory drugs. * History of steroid-induced intraocular pressure (IOP) rise. * Currently on medication for ocular hypertension or glaucoma in the study eye. * Diabetes. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With an Anterior Cell Grade of 0 (no Cells) at Day 15 ± 2 Days | Day 15 ± 2 days | Anterior cell grade was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 5-point scale: Grade 0=0 cells; Grade 1=1 to 10 cells; Grade 2=11 to 20 cells; Grade 3=21 to 50 cells; Grade 4=\>50 cells. The presence of blood cells (red and white) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week | Anterior chamber cell grade was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 5-point scale: Grade 0=0 cells; Grade 1=1 to 10 cells; Grade 2=11 to 20 cells; Grade 3=21 to 50 cells; Grade 4=\>50 cells. The presence of blood cells (red and white) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. |
| Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week | Anterior chamber flare was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. The presence of flare (increased protein levels) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. |
| Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week | Corneal clarity was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Lack of corneal clarity (1-3) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. |
| Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week | Conjunctival injection was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Conjunctival injection (redness of the white sclera of the eye) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. |
| Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week | Ciliary/limbal injection was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Ciliary/limbal injection (redness of the white sclera of the eye near the limbal ring) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. |
| Global Assessment Score of Postoperative Inflammation by Visit | Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week | A Global Assessment Score (GAS) was assigned by the Investigator based on the clinical evidence of postoperative inflammation: 0=clear, 1=improving satisfactorily; 2=not improving or worsening, withdrawal from study indicated to allow appropriate alternative therapy to be instituted. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. |
| Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week | Hypopyon was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Hypopyon (pus in the anterior chamber of the eye) is a sign of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. |
| Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week | Vitritis was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Vitritis (accumulation of inflammatory cells or exudates in the vitreous humor, the fluid that fills the middle chamber of the eye) is a sign of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. |
| Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week | Wound integrity was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Lack of wound integrity (healing, 1-3) is a sign of inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. |
| Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week | Photophobia was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Photophobia (abnormal intolerance to visual perception of light) is a symptom of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. |
| Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week | Lacrimation was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Excessive lacrimation (tear production and secretion, 1-3) is a symptom of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. |
| Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week | Chemosis was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Chemosis (swelling of the conjunctiva) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. |
Countries
United States
Participant flow
Recruitment details
Patients were screened and recruited from 17 study centers located within the United States.
Pre-assignment details
This reporting group includes all patients who were exposed to the study drug. One patient randomized to DUREZOL withdrew consent prior to receiving study medication.
Participants by arm
| Arm | Count |
|---|---|
| DUREZOL Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment | 39 |
| PRED FORTE Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment | 40 |
| Total | 79 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Physician Decision | 0 | 2 |
Baseline characteristics
| Characteristic | Total | DUREZOL | PRED FORTE |
|---|---|---|---|
| Age, Customized Children: 2 to 3 years | 19 participants | 8 participants | 11 participants |
| Age, Customized Infants and Toddlers: 28 days to 23 months | 54 participants | 28 participants | 26 participants |
| Age, Customized Newborns: 0 to 27 days | 6 participants | 3 participants | 3 participants |
| Region of Enrollment United States | 79 participants | 39 participants | 40 participants |
| Sex: Female, Male Female | 42 Participants | 22 Participants | 20 Participants |
| Sex: Female, Male Male | 37 Participants | 17 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 39 | 10 / 40 |
| serious Total, serious adverse events | 8 / 39 | 11 / 40 |
Outcome results
Primary
Percentage of Patients With an Anterior Cell Grade of 0 (no Cells) at Day 15 ± 2 Days
Anterior cell grade was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 5-point scale: Grade 0=0 cells; Grade 1=1 to 10 cells; Grade 2=11 to 20 cells; Grade 3=21 to 50 cells; Grade 4=\>50 cells. The presence of blood cells (red and white) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation.
Time frame: Day 15 ± 2 days
Population: Intent-to-treat (ITT): All patients who received at least 1 dose of study medication. One patient (DUREZOL) had missing anterior cell grade assessment at all visits.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DUREZOL | Percentage of Patients With an Anterior Cell Grade of 0 (no Cells) at Day 15 ± 2 Days | 78.9 Percentage of patients |
| PRED FORTE | Percentage of Patients With an Anterior Cell Grade of 0 (no Cells) at Day 15 ± 2 Days | 77.5 Percentage of patients |
Secondary
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade
Anterior chamber cell grade was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 5-point scale: Grade 0=0 cells; Grade 1=1 to 10 cells; Grade 2=11 to 20 cells; Grade 3=21 to 50 cells; Grade 4=\>50 cells. The presence of blood cells (red and white) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.
Time frame: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week
Population: Intent-to-treat (ITT): All patients who received at least 1 dose of study medication. One patient had missing anterior cell grade assessment at all visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 15: Grade 0 | 78.9 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 29: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 29: Grade 4 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | 1 Week after Last Dose: Grade 0 | 97.4 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | 1 Week after Last Dose: Grade 1 | 2.6 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | 1 Week after Last Dose: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | 1 Week after Last Dose: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | 1 Week After Last Dose: Grade 4 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Month 3: Grade 0 | 94.7 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Month 3: Grade 1 | 5.3 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Month 3: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Month 3: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Month 3: Grade 4 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 1: Grade 0 | 23.7 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 1: Grade 1 | 57.9 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 1: Grade 2 | 15.8 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 1: Grade 3 | 2.6 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 1: Grade 4 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 8: Grade 0 | 55.3 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 8: Grade 1 | 36.8 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 8: Grade 2 | 5.3 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 8: Grade 3 | 2.6 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 8: Grade 4 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 15: Grade 1 | 18.4 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 15: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 15: Grade 3 | 2.6 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 15: Grade 4 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 29: Grade 0 | 89.5 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 29: Grade 1 | 10.5 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 29: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 1: Grade 2 | 27.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 15: Grade 0 | 77.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 29: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 1: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 29: Grade 4 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 29: Grade 0 | 95.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | 1 Week after Last Dose: Grade 0 | 95.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 1: Grade 4 | 2.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | 1 Week after Last Dose: Grade 1 | 2.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 15: Grade 1 | 17.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | 1 Week after Last Dose: Grade 2 | 2.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 8: Grade 0 | 57.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | 1 Week after Last Dose: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 15: Grade 4 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | 1 Week After Last Dose: Grade 4 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 8: Grade 1 | 32.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Month 3: Grade 0 | 97.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 15: Grade 2 | 5.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Month 3: Grade 1 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 8: Grade 2 | 10.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Month 3: Grade 2 | 2.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 29: Grade 1 | 2.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Month 3: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 8: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Month 3: Grade 4 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 15: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 1: Grade 0 | 40.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 8: Grade 4 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 1: Grade 1 | 30.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Day 29: Grade 2 | 2.5 Percentage of patients |
Secondary
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade
Anterior chamber flare was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. The presence of flare (increased protein levels) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.
Time frame: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week
Population: Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Day 8: Grade 2 | 2.6 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Day 1: Grade 1 | 51.3 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Day 1: Grade 2 | 7.7 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Day 1: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Day 8: Grade 0 | 61.5 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Day 8: Grade 1 | 35.9 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Day 1: Grade 0 | 41.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Day 8: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Day 15: Grade 0 | 74.4 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Day 15: Grade 1 | 17.9 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Day 15: Grade 2 | 7.7 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Day 15: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Day 29: Grade 0 | 87.2 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Day 29: Grade 1 | 12.8 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Day 29: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Day 29: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | 1 Week after Last Dose: Grade 0 | 94.9 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | 1 Week after Last Dose: Grade 1 | 2.6 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | 1 Week after Last Dose: Grade 2 | 2.6 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | 1 Week after Last Dose: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Month 3: Grade 0 | 92.3 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Month 3: Grade 1 | 5.1 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Month 3: Grade 2 | 2.6 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Month 3: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Month 3: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Day 1: Grade 0 | 45.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Day 29: Grade 0 | 92.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Day 1: Grade 1 | 37.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | 1 Week after Last Dose: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Day 1: Grade 2 | 12.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Day 29: Grade 1 | 7.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Day 1: Grade 3 | 5.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Month 3: Grade 1 | 5.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Day 8: Grade 0 | 52.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Day 29: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Day 8: Grade 1 | 40.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | 1 Week after Last Dose: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Day 8: Grade 2 | 5.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Day 29: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Day 8: Grade 3 | 2.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Month 3: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Day 15: Grade 0 | 70.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | 1 Week after Last Dose: Grade 0 | 92.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Day 15: Grade 1 | 27.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Month 3: Grade 0 | 95.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Day 15: Grade 2 | 2.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | 1 Week after Last Dose: Grade 1 | 7.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Day 15: Grade 3 | 0.0 Percentage of patients |
Secondary
Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis
Chemosis was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Chemosis (swelling of the conjunctiva) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.
Time frame: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week
Population: Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Day 8: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Day 1: Grade 1 | 15.4 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Day 1: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Day 1: Grade 3 | 2.6 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Day 8: Grade 0 | 97.4 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Day 8: Grade 1 | 2.6 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Day 1: Grade 0 | 82.1 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Day 8: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Day 15: Grade 0 | 100.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Day 15: Grade 1 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Day 15: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Day 15: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Day 29: Grade 0 | 100.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Day 29: Grade 1 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Day 29: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Day 29: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | 1 Week after Last Dose: Grade 0 | 100.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | 1 Week after Last Dose: Grade 1 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | 1 Week after Last Dose: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | 1 Week after Last Dose: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Month 3: Grade 0 | 100.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Month 3: Grade 1 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Month 3: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Month 3: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Month 3: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Day 1: Grade 0 | 85.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Day 29: Grade 0 | 100.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Day 1: Grade 1 | 15.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | 1 Week after Last Dose: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Day 1: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Day 29: Grade 1 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Day 1: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Month 3: Grade 1 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Day 8: Grade 0 | 100.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Day 29: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Day 8: Grade 1 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | 1 Week after Last Dose: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Day 8: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Day 29: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Day 8: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Month 3: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Day 15: Grade 0 | 97.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | 1 Week after Last Dose: Grade 0 | 100.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Day 15: Grade 1 | 2.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Month 3: Grade 0 | 100.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Day 15: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | 1 Week after Last Dose: Grade 1 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Day 15: Grade 3 | 0.0 Percentage of patients |
Secondary
Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection
Ciliary/limbal injection was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Ciliary/limbal injection (redness of the white sclera of the eye near the limbal ring) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.
Time frame: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week
Population: Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Day 8: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Day 1: Grade 1 | 28.2 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Day 1: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Day 1: Grade 3 | 2.6 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Day 8: Grade 0 | 89.7 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Day 8: Grade 1 | 10.3 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Day 1: Grade 0 | 69.2 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Day 8: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Day 15: Grade 0 | 100.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Day 15: Grade 1 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Day 15: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Day 15: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Day 29: Grade 0 | 100.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Day 29: Grade 1 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Day 29: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Day 29: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | 1 Week after Last Dose: Grade 0 | 100.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | 1 Week after Last Dose: Grade 1 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | 1 Week after Last Dose: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | 1 Week after Last Dose: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Month 3: Grade 0 | 100.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Month 3: Grade 1 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Month 3: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Month 3: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Month 3: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Day 1: Grade 0 | 57.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Day 29: Grade 0 | 97.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Day 1: Grade 1 | 40.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | 1 Week after Last Dose: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Day 1: Grade 2 | 2.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Day 29: Grade 1 | 2.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Day 1: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Month 3: Grade 1 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Day 8: Grade 0 | 90.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Day 29: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Day 8: Grade 1 | 10.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | 1 Week after Last Dose: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Day 8: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Day 29: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Day 8: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Month 3: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Day 15: Grade 0 | 100.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | 1 Week after Last Dose: Grade 0 | 100.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Day 15: Grade 1 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Month 3: Grade 0 | 100.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Day 15: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | 1 Week after Last Dose: Grade 1 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Day 15: Grade 3 | 0.0 Percentage of patients |
Secondary
Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection
Conjunctival injection was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Conjunctival injection (redness of the white sclera of the eye) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.
Time frame: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week
Population: Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Day 8: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Day 1: Grade 1 | 48.7 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Day 1: Grade 2 | 2.6 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Day 1: Grade 3 | 2.6 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Day 8: Grade 0 | 79.5 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Day 8: Grade 1 | 20.5 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Day 1: Grade 0 | 46.2 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Day 8: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Day 15: Grade 0 | 89.7 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Day 15: Grade 1 | 10.3 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Day 15: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Day 15: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Day 29: Grade 0 | 97.4 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Day 29: Grade 1 | 2.6 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Day 29: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Day 29: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | 1 Week after Last Dose: Grade 0 | 100.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | 1 Week after Last Dose: Grade 1 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | 1 Week after Last Dose: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | 1 Week after Last Dose: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Month 3: Grade 0 | 100.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Month 3: Grade 1 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Month 3: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Month 3: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Month 3: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Day 1: Grade 0 | 25.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Day 29: Grade 0 | 95.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Day 1: Grade 1 | 65.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | 1 Week after Last Dose: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Day 1: Grade 2 | 10.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Day 29: Grade 1 | 5.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Day 1: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Month 3: Grade 1 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Day 8: Grade 0 | 77.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Day 29: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Day 8: Grade 1 | 22.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | 1 Week after Last Dose: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Day 8: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Day 29: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Day 8: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Month 3: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Day 15: Grade 0 | 92.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | 1 Week after Last Dose: Grade 0 | 100.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Day 15: Grade 1 | 7.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Month 3: Grade 0 | 100.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Day 15: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | 1 Week after Last Dose: Grade 1 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Day 15: Grade 3 | 0.0 Percentage of patients |
Secondary
Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity
Corneal clarity was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Lack of corneal clarity (1-3) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.
Time frame: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week
Population: Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Day 8: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Day 1: Grade 1 | 7.7 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Day 1: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Day 1: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Day 8: Grade 0 | 94.9 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Day 8: Grade 1 | 5.1 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Day 1: Grade 0 | 92.3 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Day 8: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Day 15: Grade 0 | 94.9 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Day 15: Grade 1 | 5.1 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Day 15: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Day 15: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Day 29: Grade 0 | 97.4 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Day 29: Grade 1 | 2.6 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Day 29: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Day 29: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | 1 Week after Last Dose: Grade 0 | 100.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | 1 Week after Last Dose: Grade 1 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | 1 Week after Last Dose: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | 1 Week after Last Dose: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Month 3: Grade 0 | 100.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Month 3: Grade 1 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Month 3: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Month 3: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Month 3: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Day 1: Grade 0 | 87.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Day 29: Grade 0 | 97.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Day 1: Grade 1 | 12.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | 1 Week after Last Dose: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Day 1: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Day 29: Grade 1 | 2.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Day 1: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Month 3: Grade 1 | 2.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Day 8: Grade 0 | 90.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Day 29: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Day 8: Grade 1 | 7.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | 1 Week after Last Dose: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Day 8: Grade 2 | 2.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Day 29: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Day 8: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Month 3: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Day 15: Grade 0 | 90.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | 1 Week after Last Dose: Grade 0 | 97.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Day 15: Grade 1 | 10.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Month 3: Grade 0 | 97.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Day 15: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | 1 Week after Last Dose: Grade 1 | 2.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Day 15: Grade 3 | 0.0 Percentage of patients |
Secondary
Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon
Hypopyon was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Hypopyon (pus in the anterior chamber of the eye) is a sign of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.
Time frame: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week
Population: Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Day 8: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Day 1: Grade 1 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Day 1: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Day 1: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Day 8: Grade 0 | 100.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Day 8: Grade 1 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Day 1: Grade 0 | 100.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Day 8: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Day 15: Grade 0 | 100.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Day 15: Grade 1 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Day 15: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Day 15: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Day 29: Grade 0 | 100.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Day 29: Grade 1 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Day 29: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Day 29: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | 1 Week after Last Dose: Grade 0 | 100.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | 1 Week after Last Dose: Grade 1 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | 1 Week after Last Dose: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | 1 Week after Last Dose: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Month 3: Grade 0 | 100.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Month 3: Grade 1 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Month 3: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Month 3: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Month 3: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Day 1: Grade 0 | 100.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Day 29: Grade 0 | 100.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Day 1: Grade 1 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | 1 Week after Last Dose: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Day 1: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Day 29: Grade 1 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Day 1: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Month 3: Grade 1 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Day 8: Grade 0 | 100.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Day 29: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Day 8: Grade 1 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | 1 Week after Last Dose: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Day 8: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Day 29: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Day 8: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Month 3: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Day 15: Grade 0 | 100.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | 1 Week after Last Dose: Grade 0 | 100.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Day 15: Grade 1 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Month 3: Grade 0 | 100.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Day 15: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | 1 Week after Last Dose: Grade 1 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Day 15: Grade 3 | 0.0 Percentage of patients |
Secondary
Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation
Lacrimation was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Excessive lacrimation (tear production and secretion, 1-3) is a symptom of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.
Time frame: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week
Population: Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Day 1: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Day 29: Grade 0 | 100.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Day 8: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Day 1: Grade 2 | 5.1 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Day 29: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Day 8: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Day 29: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Day 29: Grade 1 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | 1 Week after Last Dose: Grade 0 | 100.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Day 15: Grade 0 | 100.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | 1 Week after Last Dose: Grade 1 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Day 8: Grade 0 | 94.9 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | 1 Week after Last Dose: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Day 15: Grade 1 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | 1 Week after Last Dose: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Day 1: Grade 1 | 30.8 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Month 3: Grade 0 | 100.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Day 15: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Month 3: Grade 1 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Day 8: Grade 1 | 5.1 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Month 3: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Day 15: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Month 3: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Day 1: Grade 0 | 64.1 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Month 3: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Day 1: Grade 0 | 72.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Day 1: Grade 1 | 22.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Day 1: Grade 2 | 5.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Day 1: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Day 8: Grade 0 | 97.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Day 8: Grade 1 | 2.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Day 8: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Day 8: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Day 15: Grade 0 | 95.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Day 15: Grade 1 | 5.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Day 15: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Day 15: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Day 29: Grade 0 | 100.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Day 29: Grade 1 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Day 29: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Day 29: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | 1 Week after Last Dose: Grade 0 | 100.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | 1 Week after Last Dose: Grade 1 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | 1 Week after Last Dose: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | 1 Week after Last Dose: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Month 3: Grade 0 | 100.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Month 3: Grade 1 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Month 3: Grade 2 | 0.0 Percentage of patients |
Secondary
Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia
Photophobia was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Photophobia (abnormal intolerance to visual perception of light) is a symptom of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.
Time frame: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week
Population: Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Day 8: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Day 1: Grade 1 | 20.5 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Day 1: Grade 2 | 7.7 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Day 1: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Day 8: Grade 0 | 89.7 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Day 8: Grade 1 | 10.3 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Day 1: Grade 0 | 71.8 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Day 8: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Day 15: Grade 0 | 97.4 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Day 15: Grade 1 | 2.6 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Day 15: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Day 15: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Day 29: Grade 0 | 97.4 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Day 29: Grade 1 | 2.6 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Day 29: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Day 29: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | 1 Week after Last Dose: Grade 0 | 100.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | 1 Week after Last Dose: Grade 1 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | 1 Week after Last Dose: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | 1 Week after Last Dose: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Month 3: Grade 0 | 100.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Month 3: Grade 1 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Month 3: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Month 3: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Month 3: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Day 1: Grade 0 | 60.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Day 29: Grade 0 | 92.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Day 1: Grade 1 | 35.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | 1 Week after Last Dose: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Day 1: Grade 2 | 5.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Day 29: Grade 1 | 5.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Day 1: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Month 3: Grade 1 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Day 8: Grade 0 | 87.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Day 29: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Day 8: Grade 1 | 10.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | 1 Week after Last Dose: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Day 8: Grade 2 | 2.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Day 29: Grade 3 | 2.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Day 8: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Month 3: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Day 15: Grade 0 | 95.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | 1 Week after Last Dose: Grade 0 | 97.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Day 15: Grade 1 | 5.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Month 3: Grade 0 | 100.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Day 15: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | 1 Week after Last Dose: Grade 1 | 2.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Day 15: Grade 3 | 0.0 Percentage of patients |
Secondary
Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis
Vitritis was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Vitritis (accumulation of inflammatory cells or exudates in the vitreous humor, the fluid that fills the middle chamber of the eye) is a sign of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.
Time frame: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week
Population: Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Day 8: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Day 1: Grade 1 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Day 1: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Day 1: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Day 8: Grade 0 | 100.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Day 8: Grade 1 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Day 1: Grade 0 | 100.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Day 8: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Day 15: Grade 0 | 100.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Day 15: Grade 1 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Day 15: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Day 15: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Day 29: Grade 0 | 100.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Day 29: Grade 1 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Day 29: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Day 29: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | 1 Week after Last Dose: Grade 0 | 100.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | 1 Week after Last Dose: Grade 1 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | 1 Week after Last Dose: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | 1 Week after Last Dose: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Month 3: Grade 0 | 100.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Month 3: Grade 1 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Month 3: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Month 3: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Month 3: Grade 2 | 2.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Day 1: Grade 0 | 97.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Day 29: Grade 0 | 97.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Day 1: Grade 1 | 2.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | 1 Week after Last Dose: Grade 2 | 2.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Day 1: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Day 29: Grade 1 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Day 1: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Month 3: Grade 1 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Day 8: Grade 0 | 97.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Day 29: Grade 2 | 2.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Day 8: Grade 1 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | 1 Week after Last Dose: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Day 8: Grade 2 | 2.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Day 29: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Day 8: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Month 3: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Day 15: Grade 0 | 97.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | 1 Week after Last Dose: Grade 0 | 97.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Day 15: Grade 1 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Month 3: Grade 0 | 97.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Day 15: Grade 2 | 2.5 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | 1 Week after Last Dose: Grade 1 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Day 15: Grade 3 | 0.0 Percentage of patients |
Secondary
Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity
Wound integrity was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Lack of wound integrity (healing, 1-3) is a sign of inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.
Time frame: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week
Population: Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Day 8: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Day 1: Grade 1 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Day 1: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Day 1: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Day 8: Grade 0 | 100.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Day 8: Grade 1 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Day 1: Grade 0 | 100.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Day 8: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Day 15: Grade 0 | 100.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Day 15: Grade 1 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Day 15: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Day 15: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Day 29: Grade 0 | 100.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Day 29: Grade 1 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Day 29: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Day 29: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | 1 Week after Last Dose: Grade 0 | 100.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | 1 Week after Last Dose: Grade 1 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | 1 Week after Last Dose: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | 1 Week after Last Dose: Grade 3 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Month 1: Grade 0 | 100.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Month 1: Grade 1 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Month 1: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Month 1: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Month 1: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Day 1: Grade 0 | 100.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Day 29: Grade 0 | 100.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Day 1: Grade 1 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | 1 Week after Last Dose: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Day 1: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Day 29: Grade 1 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Day 1: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Month 1: Grade 1 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Day 8: Grade 0 | 100.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Day 29: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Day 8: Grade 1 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | 1 Week after Last Dose: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Day 8: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Day 29: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Day 8: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Month 1: Grade 3 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Day 15: Grade 0 | 100.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | 1 Week after Last Dose: Grade 0 | 100.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Day 15: Grade 1 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Month 1: Grade 0 | 100.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Day 15: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | 1 Week after Last Dose: Grade 1 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Day 15: Grade 3 | 0.0 Percentage of patients |
Secondary
Global Assessment Score of Postoperative Inflammation by Visit
A Global Assessment Score (GAS) was assigned by the Investigator based on the clinical evidence of postoperative inflammation: 0=clear, 1=improving satisfactorily; 2=not improving or worsening, withdrawal from study indicated to allow appropriate alternative therapy to be instituted. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.
Time frame: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week
Population: Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DUREZOL | Global Assessment Score of Postoperative Inflammation by Visit | Day 8: Grade 1 | 48.7 Percentage of patients |
| DUREZOL | Global Assessment Score of Postoperative Inflammation by Visit | Day 29: Grade 0 | 79.5 Percentage of patients |
| DUREZOL | Global Assessment Score of Postoperative Inflammation by Visit | Day 1: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment Score of Postoperative Inflammation by Visit | Day 29: Grade 1 | 20.5 Percentage of patients |
| DUREZOL | Global Assessment Score of Postoperative Inflammation by Visit | Day 8: Grade 2 | 2.6 Percentage of patients |
| DUREZOL | Global Assessment Score of Postoperative Inflammation by Visit | Day 29: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment Score of Postoperative Inflammation by Visit | Day 1: Grade 1 | 69.2 Percentage of patients |
| DUREZOL | Global Assessment Score of Postoperative Inflammation by Visit | 1 Week after Last Dose: Grade 0 | 89.7 Percentage of patients |
| DUREZOL | Global Assessment Score of Postoperative Inflammation by Visit | Day 15: Grade 0 | 56.4 Percentage of patients |
| DUREZOL | Global Assessment Score of Postoperative Inflammation by Visit | 1 Week after Last Dose: Grade 1 | 7.7 Percentage of patients |
| DUREZOL | Global Assessment Score of Postoperative Inflammation by Visit | Day 8: Grade 0 | 48.7 Percentage of patients |
| DUREZOL | Global Assessment Score of Postoperative Inflammation by Visit | 1 Week after Last Dose: Grade 2 | 2.6 Percentage of patients |
| DUREZOL | Global Assessment Score of Postoperative Inflammation by Visit | Day 15: Grade 1 | 43.6 Percentage of patients |
| DUREZOL | Global Assessment Score of Postoperative Inflammation by Visit | Month 3: Grade 0 | 92.3 Percentage of patients |
| DUREZOL | Global Assessment Score of Postoperative Inflammation by Visit | Day 1: Grade 0 | 30.8 Percentage of patients |
| DUREZOL | Global Assessment Score of Postoperative Inflammation by Visit | Month 3: Grade 1 | 5.1 Percentage of patients |
| DUREZOL | Global Assessment Score of Postoperative Inflammation by Visit | Day 15: Grade 2 | 0.0 Percentage of patients |
| DUREZOL | Global Assessment Score of Postoperative Inflammation by Visit | Month 3: Grade 2 | 2.6 Percentage of patients |
| PRED FORTE | Global Assessment Score of Postoperative Inflammation by Visit | Day 15: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment Score of Postoperative Inflammation by Visit | Day 1: Grade 0 | 17.5 Percentage of patients |
| PRED FORTE | Global Assessment Score of Postoperative Inflammation by Visit | Day 1: Grade 1 | 82.5 Percentage of patients |
| PRED FORTE | Global Assessment Score of Postoperative Inflammation by Visit | Day 1: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment Score of Postoperative Inflammation by Visit | Day 8: Grade 0 | 25.0 Percentage of patients |
| PRED FORTE | Global Assessment Score of Postoperative Inflammation by Visit | Day 8: Grade 1 | 70.0 Percentage of patients |
| PRED FORTE | Global Assessment Score of Postoperative Inflammation by Visit | Day 8: Grade 2 | 5.0 Percentage of patients |
| PRED FORTE | Global Assessment Score of Postoperative Inflammation by Visit | Day 15: Grade 0 | 50.0 Percentage of patients |
| PRED FORTE | Global Assessment Score of Postoperative Inflammation by Visit | Day 15: Grade 1 | 50.0 Percentage of patients |
| PRED FORTE | Global Assessment Score of Postoperative Inflammation by Visit | Month 3: Grade 2 | 0.0 Percentage of patients |
| PRED FORTE | Global Assessment Score of Postoperative Inflammation by Visit | Day 29: Grade 0 | 72.5 Percentage of patients |
| PRED FORTE | Global Assessment Score of Postoperative Inflammation by Visit | Day 29: Grade 1 | 25.0 Percentage of patients |
| PRED FORTE | Global Assessment Score of Postoperative Inflammation by Visit | Day 29: Grade 2 | 2.5 Percentage of patients |
| PRED FORTE | Global Assessment Score of Postoperative Inflammation by Visit | 1 Week after Last Dose: Grade 0 | 90.0 Percentage of patients |
| PRED FORTE | Global Assessment Score of Postoperative Inflammation by Visit | 1 Week after Last Dose: Grade 1 | 7.5 Percentage of patients |
| PRED FORTE | Global Assessment Score of Postoperative Inflammation by Visit | 1 Week after Last Dose: Grade 2 | 2.5 Percentage of patients |
| PRED FORTE | Global Assessment Score of Postoperative Inflammation by Visit | Month 3: Grade 0 | 92.5 Percentage of patients |
| PRED FORTE | Global Assessment Score of Postoperative Inflammation by Visit | Month 3: Grade 1 | 7.5 Percentage of patients |