Trial Outcomes & Findings for Difluprednate Pediatric Study for the Treatment of Inflammation Post-Cataract Surgery (NCT NCT01124045)
NCT ID: NCT01124045
Last Updated: 2013-06-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
80 participants
Primary outcome timeframe
Day 15 ± 2 days
Results posted on
2013-06-19
Participant Flow
Patients were screened and recruited from 17 study centers located within the United States.
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.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
40
|
|
Overall Study
COMPLETED
|
39
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
2
|
Baseline Characteristics
Difluprednate Pediatric Study for the Treatment of Inflammation Post-Cataract Surgery
Baseline characteristics by cohort
| Measure |
DUREZOL
n=39 Participants
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
|
PRED FORTE
n=40 Participants
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
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Newborns: 0 to 27 days
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Age, Customized
Infants and Toddlers: 28 days to 23 months
|
28 participants
n=5 Participants
|
26 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Age, Customized
Children: 2 to 3 years
|
8 participants
n=5 Participants
|
11 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
40 participants
n=7 Participants
|
79 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 15 ± 2 daysPopulation: 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.
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.
Outcome measures
| Measure |
DUREZOL
n=38 Participants
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
|
PRED FORTE
n=40 Participants
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
|
|---|---|---|
|
Percentage of Patients With an Anterior Cell Grade of 0 (no Cells) at Day 15 ± 2 Days
|
78.9 Percentage of patients
|
77.5 Percentage of patients
|
SECONDARY outcome
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 weekPopulation: Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
DUREZOL
n=39 Participants
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
|
PRED FORTE
n=40 Participants
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
|
|---|---|---|
|
Global Assessment Score of Postoperative Inflammation by Visit
Day 1: Grade 1
|
69.2 Percentage of patients
|
82.5 Percentage of patients
|
|
Global Assessment Score of Postoperative Inflammation by Visit
1 Week after Last Dose: Grade 2
|
2.6 Percentage of patients
|
2.5 Percentage of patients
|
|
Global Assessment Score of Postoperative Inflammation by Visit
Day 1: Grade 0
|
30.8 Percentage of patients
|
17.5 Percentage of patients
|
|
Global Assessment Score of Postoperative Inflammation by Visit
Day 1: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment Score of Postoperative Inflammation by Visit
Day 8: Grade 0
|
48.7 Percentage of patients
|
25.0 Percentage of patients
|
|
Global Assessment Score of Postoperative Inflammation by Visit
Day 8: Grade 1
|
48.7 Percentage of patients
|
70.0 Percentage of patients
|
|
Global Assessment Score of Postoperative Inflammation by Visit
Day 8: Grade 2
|
2.6 Percentage of patients
|
5.0 Percentage of patients
|
|
Global Assessment Score of Postoperative Inflammation by Visit
Day 15: Grade 0
|
56.4 Percentage of patients
|
50.0 Percentage of patients
|
|
Global Assessment Score of Postoperative Inflammation by Visit
Day 15: Grade 1
|
43.6 Percentage of patients
|
50.0 Percentage of patients
|
|
Global Assessment Score of Postoperative Inflammation by Visit
Day 15: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment Score of Postoperative Inflammation by Visit
Day 29: Grade 0
|
79.5 Percentage of patients
|
72.5 Percentage of patients
|
|
Global Assessment Score of Postoperative Inflammation by Visit
Day 29: Grade 1
|
20.5 Percentage of patients
|
25.0 Percentage of patients
|
|
Global Assessment Score of Postoperative Inflammation by Visit
Day 29: Grade 2
|
0.0 Percentage of patients
|
2.5 Percentage of patients
|
|
Global Assessment Score of Postoperative Inflammation by Visit
1 Week after Last Dose: Grade 0
|
89.7 Percentage of patients
|
90.0 Percentage of patients
|
|
Global Assessment Score of Postoperative Inflammation by Visit
1 Week after Last Dose: Grade 1
|
7.7 Percentage of patients
|
7.5 Percentage of patients
|
|
Global Assessment Score of Postoperative Inflammation by Visit
Month 3: Grade 0
|
92.3 Percentage of patients
|
92.5 Percentage of patients
|
|
Global Assessment Score of Postoperative Inflammation by Visit
Month 3: Grade 1
|
5.1 Percentage of patients
|
7.5 Percentage of patients
|
|
Global Assessment Score of Postoperative Inflammation by Visit
Month 3: Grade 2
|
2.6 Percentage of patients
|
0.0 Percentage of patients
|
SECONDARY outcome
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 weekPopulation: 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.
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.
Outcome measures
| Measure |
DUREZOL
n=38 Participants
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
|
PRED FORTE
n=40 Participants
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
|
|---|---|---|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade
Day 1: Grade 0
|
23.7 Percentage of patients
|
40.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade
Day 8: Grade 3
|
2.6 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade
Day 29: Grade 4
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade
Month 3: Grade 0
|
94.7 Percentage of patients
|
97.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade
Month 3: Grade 1
|
5.3 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade
Month 3: Grade 4
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade
Day 1: Grade 1
|
57.9 Percentage of patients
|
30.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade
Day 1: Grade 2
|
15.8 Percentage of patients
|
27.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade
Day 1: Grade 3
|
2.6 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade
Day 1: Grade 4
|
0.0 Percentage of patients
|
2.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade
Day 8: Grade 0
|
55.3 Percentage of patients
|
57.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade
Day 8: Grade 1
|
36.8 Percentage of patients
|
32.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade
Day 8: Grade 2
|
5.3 Percentage of patients
|
10.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade
Day 8: Grade 4
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade
Day 15: Grade 0
|
78.9 Percentage of patients
|
77.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade
Day 15: Grade 1
|
18.4 Percentage of patients
|
17.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade
Day 15: Grade 2
|
0.0 Percentage of patients
|
5.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade
Day 15: Grade 3
|
2.6 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade
Day 15: Grade 4
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade
Day 29: Grade 0
|
89.5 Percentage of patients
|
95.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade
Day 29: Grade 1
|
10.5 Percentage of patients
|
2.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade
Day 29: Grade 2
|
0.0 Percentage of patients
|
2.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade
Day 29: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
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
|
95.0 Percentage of patients
|
|
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
|
2.5 Percentage of patients
|
|
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
|
2.5 Percentage of patients
|
|
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
|
0.0 Percentage of patients
|
|
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
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade
Month 3: Grade 2
|
0.0 Percentage of patients
|
2.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade
Month 3: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
SECONDARY outcome
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 weekPopulation: Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
DUREZOL
n=38 Participants
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
|
PRED FORTE
n=40 Participants
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
|
|---|---|---|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade
Day 1: Grade 0
|
41.0 Percentage of patients
|
45.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade
Day 1: Grade 1
|
51.3 Percentage of patients
|
37.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade
Day 8: Grade 0
|
61.5 Percentage of patients
|
52.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade
Day 15: Grade 0
|
74.4 Percentage of patients
|
70.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade
Day 15: Grade 1
|
17.9 Percentage of patients
|
27.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade
Day 15: Grade 2
|
7.7 Percentage of patients
|
2.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade
Day 15: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade
Day 29: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
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
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade
Month 3: Grade 2
|
2.6 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade
Day 1: Grade 2
|
7.7 Percentage of patients
|
12.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade
Day 1: Grade 3
|
0.0 Percentage of patients
|
5.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade
Day 8: Grade 1
|
35.9 Percentage of patients
|
40.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade
Day 8: Grade 2
|
2.6 Percentage of patients
|
5.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade
Day 8: Grade 3
|
0.0 Percentage of patients
|
2.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade
Day 29: Grade 0
|
87.2 Percentage of patients
|
92.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade
Day 29: Grade 1
|
12.8 Percentage of patients
|
7.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade
Day 29: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
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
|
92.5 Percentage of patients
|
|
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
|
7.5 Percentage of patients
|
|
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
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade
Month 3: Grade 0
|
92.3 Percentage of patients
|
95.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade
Month 3: Grade 1
|
5.1 Percentage of patients
|
5.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade
Month 3: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
SECONDARY outcome
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 weekPopulation: Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
DUREZOL
n=39 Participants
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
|
PRED FORTE
n=40 Participants
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
|
|---|---|---|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity
Day 1: Grade 1
|
7.7 Percentage of patients
|
12.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity
Day 8: Grade 2
|
0.0 Percentage of patients
|
2.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity
Day 29: Grade 1
|
2.6 Percentage of patients
|
2.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity
Day 1: Grade 0
|
92.3 Percentage of patients
|
87.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity
Day 1: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity
Day 1: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity
Day 8: Grade 0
|
94.9 Percentage of patients
|
90.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity
Day 8: Grade 1
|
5.1 Percentage of patients
|
7.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity
Day 8: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity
Day 15: Grade 0
|
94.9 Percentage of patients
|
90.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity
Day 15: Grade 1
|
5.1 Percentage of patients
|
10.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity
Day 15: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity
Day 15: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity
Day 29: Grade 0
|
97.4 Percentage of patients
|
97.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity
Day 29: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity
Day 29: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity
1 Week after Last Dose: Grade 0
|
100.0 Percentage of patients
|
97.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity
1 Week after Last Dose: Grade 1
|
0.0 Percentage of patients
|
2.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity
1 Week after Last Dose: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity
1 Week after Last Dose: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity
Month 3: Grade 0
|
100.0 Percentage of patients
|
97.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity
Month 3: Grade 1
|
0.0 Percentage of patients
|
2.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity
Month 3: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity
Month 3: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
SECONDARY outcome
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 weekPopulation: Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
DUREZOL
n=39 Participants
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
|
PRED FORTE
n=40 Participants
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
|
|---|---|---|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection
Day 15: Grade 1
|
10.3 Percentage of patients
|
7.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection
Day 15: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection
1 Week after Last Dose: Grade 0
|
100.0 Percentage of patients
|
100.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection
1 Week after Last Dose: Grade 1
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection
Day 1: Grade 0
|
46.2 Percentage of patients
|
25.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection
Day 1: Grade 1
|
48.7 Percentage of patients
|
65.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection
Day 1: Grade 2
|
2.6 Percentage of patients
|
10.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection
Day 1: Grade 3
|
2.6 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection
Day 8: Grade 0
|
79.5 Percentage of patients
|
77.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection
Day 8: Grade 1
|
20.5 Percentage of patients
|
22.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection
Day 8: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection
Day 8: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection
Day 15: Grade 0
|
89.7 Percentage of patients
|
92.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection
Day 15: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection
Day 29: Grade 0
|
97.4 Percentage of patients
|
95.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection
Day 29: Grade 1
|
2.6 Percentage of patients
|
5.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection
Day 29: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection
Day 29: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection
1 Week after Last Dose: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection
1 Week after Last Dose: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection
Month 3: Grade 0
|
100.0 Percentage of patients
|
100.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection
Month 3: Grade 1
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection
Month 3: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection
Month 3: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
SECONDARY outcome
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 weekPopulation: Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
DUREZOL
n=39 Participants
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
|
PRED FORTE
n=40 Participants
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
|
|---|---|---|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection
Day 8: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection
1 Week after Last Dose: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection
Day 1: Grade 0
|
69.2 Percentage of patients
|
57.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection
Day 1: Grade 1
|
28.2 Percentage of patients
|
40.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection
Day 1: Grade 2
|
0.0 Percentage of patients
|
2.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection
Day 1: Grade 3
|
2.6 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection
Day 8: Grade 0
|
89.7 Percentage of patients
|
90.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection
Day 8: Grade 1
|
10.3 Percentage of patients
|
10.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection
Day 8: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection
Day 15: Grade 0
|
100.0 Percentage of patients
|
100.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection
Day 15: Grade 1
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection
Day 15: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection
Day 15: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection
Day 29: Grade 0
|
100.0 Percentage of patients
|
97.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection
Day 29: Grade 1
|
0.0 Percentage of patients
|
2.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection
Day 29: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection
Day 29: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection
1 Week after Last Dose: Grade 0
|
100.0 Percentage of patients
|
100.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection
1 Week after Last Dose: Grade 1
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection
1 Week after Last Dose: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection
Month 3: Grade 0
|
100.0 Percentage of patients
|
100.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection
Month 3: Grade 1
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection
Month 3: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection
Month 3: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
SECONDARY outcome
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 weekPopulation: Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
DUREZOL
n=39 Participants
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
|
PRED FORTE
n=40 Participants
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
|
|---|---|---|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis
Day 15: Grade 0
|
100.0 Percentage of patients
|
97.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis
Day 29: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis
Day 1: Grade 0
|
82.1 Percentage of patients
|
85.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis
Day 1: Grade 1
|
15.4 Percentage of patients
|
15.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis
Day 1: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis
Day 1: Grade 3
|
2.6 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis
Day 8: Grade 0
|
97.4 Percentage of patients
|
100.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis
Day 8: Grade 1
|
2.6 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis
Day 8: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis
Day 8: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis
Day 15: Grade 1
|
0.0 Percentage of patients
|
2.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis
Day 15: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis
Day 15: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis
Day 29: Grade 0
|
100.0 Percentage of patients
|
100.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis
Day 29: Grade 1
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis
Day 29: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis
1 Week after Last Dose: Grade 0
|
100.0 Percentage of patients
|
100.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis
1 Week after Last Dose: Grade 1
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis
1 Week after Last Dose: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis
1 Week after Last Dose: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis
Month 3: Grade 0
|
100.0 Percentage of patients
|
100.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis
Month 3: Grade 1
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis
Month 3: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis
Month 3: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
SECONDARY outcome
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 weekPopulation: Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
DUREZOL
n=39 Participants
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
|
PRED FORTE
n=40 Participants
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
|
|---|---|---|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon
Day 8: Grade 0
|
100.0 Percentage of patients
|
100.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon
Day 8: Grade 1
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon
Day 1: Grade 0
|
100.0 Percentage of patients
|
100.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon
Day 1: Grade 1
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon
Day 1: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon
Day 1: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon
Day 8: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon
Day 8: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon
Day 15: Grade 0
|
100.0 Percentage of patients
|
100.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon
Day 15: Grade 1
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon
Day 15: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon
Day 15: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon
Day 29: Grade 0
|
100.0 Percentage of patients
|
100.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon
Day 29: Grade 1
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon
Day 29: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon
Day 29: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon
1 Week after Last Dose: Grade 0
|
100.0 Percentage of patients
|
100.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon
1 Week after Last Dose: Grade 1
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon
1 Week after Last Dose: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon
1 Week after Last Dose: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon
Month 3: Grade 0
|
100.0 Percentage of patients
|
100.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon
Month 3: Grade 1
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon
Month 3: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon
Month 3: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
SECONDARY outcome
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 weekPopulation: Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
DUREZOL
n=39 Participants
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
|
PRED FORTE
n=40 Participants
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
|
|---|---|---|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis
Day 8: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis
Day 15: Grade 0
|
100.0 Percentage of patients
|
97.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis
Month 3: Grade 1
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis
Day 1: Grade 0
|
100.0 Percentage of patients
|
97.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis
Day 1: Grade 1
|
0.0 Percentage of patients
|
2.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis
Day 1: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis
Day 1: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis
Day 8: Grade 0
|
100.0 Percentage of patients
|
97.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis
Day 8: Grade 1
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis
Day 8: Grade 2
|
0.0 Percentage of patients
|
2.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis
Day 15: Grade 1
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis
Day 15: Grade 2
|
0.0 Percentage of patients
|
2.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis
Day 15: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis
Day 29: Grade 0
|
100.0 Percentage of patients
|
97.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis
Day 29: Grade 1
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis
Day 29: Grade 2
|
0.0 Percentage of patients
|
2.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis
Day 29: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis
1 Week after Last Dose: Grade 0
|
100.0 Percentage of patients
|
97.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis
1 Week after Last Dose: Grade 1
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis
1 Week after Last Dose: Grade 2
|
0.0 Percentage of patients
|
2.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis
1 Week after Last Dose: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis
Month 3: Grade 0
|
100.0 Percentage of patients
|
97.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis
Month 3: Grade 2
|
0.0 Percentage of patients
|
2.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis
Month 3: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
SECONDARY outcome
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 weekPopulation: Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
DUREZOL
n=39 Participants
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
|
PRED FORTE
n=40 Participants
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
|
|---|---|---|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity
Day 1: Grade 1
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity
Day 1: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity
Day 1: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity
Day 8: Grade 0
|
100.0 Percentage of patients
|
100.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity
Day 29: Grade 0
|
100.0 Percentage of patients
|
100.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity
Day 29: Grade 1
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity
Day 29: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity
Day 29: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity
1 Week after Last Dose: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity
Day 1: Grade 0
|
100.0 Percentage of patients
|
100.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity
Day 8: Grade 1
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity
Day 8: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity
Day 8: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity
Day 15: Grade 0
|
100.0 Percentage of patients
|
100.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity
Day 15: Grade 1
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity
Day 15: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity
Day 15: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity
1 Week after Last Dose: Grade 0
|
100.0 Percentage of patients
|
100.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity
1 Week after Last Dose: Grade 1
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity
1 Week after Last Dose: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity
Month 1: Grade 0
|
100.0 Percentage of patients
|
100.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity
Month 1: Grade 1
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity
Month 1: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity
Month 1: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
SECONDARY outcome
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 weekPopulation: Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
DUREZOL
n=39 Participants
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
|
PRED FORTE
n=40 Participants
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
|
|---|---|---|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia
Day 8: Grade 1
|
10.3 Percentage of patients
|
10.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia
Day 8: Grade 2
|
0.0 Percentage of patients
|
2.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia
Day 29: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia
Day 29: Grade 3
|
0.0 Percentage of patients
|
2.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia
1 Week after Last Dose: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia
Day 1: Grade 0
|
71.8 Percentage of patients
|
60.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia
Day 1: Grade 1
|
20.5 Percentage of patients
|
35.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia
Day 1: Grade 2
|
7.7 Percentage of patients
|
5.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia
Day 1: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia
Day 8: Grade 0
|
89.7 Percentage of patients
|
87.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia
Day 8: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia
Day 15: Grade 0
|
97.4 Percentage of patients
|
95.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia
Day 15: Grade 1
|
2.6 Percentage of patients
|
5.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia
Day 15: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia
Day 15: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia
Day 29: Grade 0
|
97.4 Percentage of patients
|
92.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia
Day 29: Grade 1
|
2.6 Percentage of patients
|
5.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia
1 Week after Last Dose: Grade 0
|
100.0 Percentage of patients
|
97.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia
1 Week after Last Dose: Grade 1
|
0.0 Percentage of patients
|
2.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia
1 Week after Last Dose: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia
Month 3: Grade 0
|
100.0 Percentage of patients
|
100.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia
Month 3: Grade 1
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia
Month 3: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia
Month 3: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
SECONDARY outcome
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 weekPopulation: Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
DUREZOL
n=39 Participants
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
|
PRED FORTE
n=40 Participants
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
|
|---|---|---|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation
Day 1: Grade 2
|
5.1 Percentage of patients
|
5.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation
Day 29: Grade 1
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation
Month 3: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation
Month 3: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation
Day 1: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation
Day 8: Grade 0
|
94.9 Percentage of patients
|
97.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation
Day 8: Grade 1
|
5.1 Percentage of patients
|
2.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation
Day 8: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation
Day 8: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation
Day 15: Grade 0
|
100.0 Percentage of patients
|
95.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation
Day 15: Grade 1
|
0.0 Percentage of patients
|
5.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation
Day 15: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation
Day 15: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation
Day 29: Grade 0
|
100.0 Percentage of patients
|
100.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation
Day 29: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation
Day 29: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation
1 Week after Last Dose: Grade 0
|
100.0 Percentage of patients
|
100.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation
1 Week after Last Dose: Grade 1
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation
1 Week after Last Dose: Grade 2
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation
1 Week after Last Dose: Grade 3
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation
Month 3: Grade 0
|
100.0 Percentage of patients
|
100.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation
Month 3: Grade 1
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation
Day 1: Grade 0
|
64.1 Percentage of patients
|
72.5 Percentage of patients
|
|
Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation
Day 1: Grade 1
|
30.8 Percentage of patients
|
22.5 Percentage of patients
|
Adverse Events
DUREZOL
Serious events: 8 serious events
Other events: 16 other events
Deaths: 0 deaths
PRED FORTE
Serious events: 11 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DUREZOL
n=39 participants at risk
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
|
PRED FORTE
n=40 participants at risk
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
|
|---|---|---|
|
Investigations
Medical observation
|
15.4%
6/39 • Adverse events were collected for the duration of the study. The safety population includes all patients who were exposed to the study drug.
An adverse event was considered to be any untoward medical occurrence in the health of a patient who was exposed to study medication, regardless of causal relationship with the study medication. Adverse events were obtained as solicited comments from the study patients and as observations by the study Investigator as outlined in the study protocol.
|
25.0%
10/40 • Adverse events were collected for the duration of the study. The safety population includes all patients who were exposed to the study drug.
An adverse event was considered to be any untoward medical occurrence in the health of a patient who was exposed to study medication, regardless of causal relationship with the study medication. Adverse events were obtained as solicited comments from the study patients and as observations by the study Investigator as outlined in the study protocol.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/39 • Adverse events were collected for the duration of the study. The safety population includes all patients who were exposed to the study drug.
An adverse event was considered to be any untoward medical occurrence in the health of a patient who was exposed to study medication, regardless of causal relationship with the study medication. Adverse events were obtained as solicited comments from the study patients and as observations by the study Investigator as outlined in the study protocol.
|
2.5%
1/40 • Adverse events were collected for the duration of the study. The safety population includes all patients who were exposed to the study drug.
An adverse event was considered to be any untoward medical occurrence in the health of a patient who was exposed to study medication, regardless of causal relationship with the study medication. Adverse events were obtained as solicited comments from the study patients and as observations by the study Investigator as outlined in the study protocol.
|
|
Investigations
Intraocular pressure increased
|
2.6%
1/39 • Adverse events were collected for the duration of the study. The safety population includes all patients who were exposed to the study drug.
An adverse event was considered to be any untoward medical occurrence in the health of a patient who was exposed to study medication, regardless of causal relationship with the study medication. Adverse events were obtained as solicited comments from the study patients and as observations by the study Investigator as outlined in the study protocol.
|
0.00%
0/40 • Adverse events were collected for the duration of the study. The safety population includes all patients who were exposed to the study drug.
An adverse event was considered to be any untoward medical occurrence in the health of a patient who was exposed to study medication, regardless of causal relationship with the study medication. Adverse events were obtained as solicited comments from the study patients and as observations by the study Investigator as outlined in the study protocol.
|
|
Immune system disorders
Cataract cortical
|
2.6%
1/39 • Adverse events were collected for the duration of the study. The safety population includes all patients who were exposed to the study drug.
An adverse event was considered to be any untoward medical occurrence in the health of a patient who was exposed to study medication, regardless of causal relationship with the study medication. Adverse events were obtained as solicited comments from the study patients and as observations by the study Investigator as outlined in the study protocol.
|
0.00%
0/40 • Adverse events were collected for the duration of the study. The safety population includes all patients who were exposed to the study drug.
An adverse event was considered to be any untoward medical occurrence in the health of a patient who was exposed to study medication, regardless of causal relationship with the study medication. Adverse events were obtained as solicited comments from the study patients and as observations by the study Investigator as outlined in the study protocol.
|
Other adverse events
| Measure |
DUREZOL
n=39 participants at risk
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
|
PRED FORTE
n=40 participants at risk
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
|
|---|---|---|
|
Eye disorders
Conjunctivitis
|
7.7%
3/39 • Adverse events were collected for the duration of the study. The safety population includes all patients who were exposed to the study drug.
An adverse event was considered to be any untoward medical occurrence in the health of a patient who was exposed to study medication, regardless of causal relationship with the study medication. Adverse events were obtained as solicited comments from the study patients and as observations by the study Investigator as outlined in the study protocol.
|
0.00%
0/40 • Adverse events were collected for the duration of the study. The safety population includes all patients who were exposed to the study drug.
An adverse event was considered to be any untoward medical occurrence in the health of a patient who was exposed to study medication, regardless of causal relationship with the study medication. Adverse events were obtained as solicited comments from the study patients and as observations by the study Investigator as outlined in the study protocol.
|
|
Eye disorders
Posterior capsule opacification
|
7.7%
3/39 • Adverse events were collected for the duration of the study. The safety population includes all patients who were exposed to the study drug.
An adverse event was considered to be any untoward medical occurrence in the health of a patient who was exposed to study medication, regardless of causal relationship with the study medication. Adverse events were obtained as solicited comments from the study patients and as observations by the study Investigator as outlined in the study protocol.
|
0.00%
0/40 • Adverse events were collected for the duration of the study. The safety population includes all patients who were exposed to the study drug.
An adverse event was considered to be any untoward medical occurrence in the health of a patient who was exposed to study medication, regardless of causal relationship with the study medication. Adverse events were obtained as solicited comments from the study patients and as observations by the study Investigator as outlined in the study protocol.
|
|
Infections and infestations
Nasopharyngitis
|
12.8%
5/39 • Adverse events were collected for the duration of the study. The safety population includes all patients who were exposed to the study drug.
An adverse event was considered to be any untoward medical occurrence in the health of a patient who was exposed to study medication, regardless of causal relationship with the study medication. Adverse events were obtained as solicited comments from the study patients and as observations by the study Investigator as outlined in the study protocol.
|
5.0%
2/40 • Adverse events were collected for the duration of the study. The safety population includes all patients who were exposed to the study drug.
An adverse event was considered to be any untoward medical occurrence in the health of a patient who was exposed to study medication, regardless of causal relationship with the study medication. Adverse events were obtained as solicited comments from the study patients and as observations by the study Investigator as outlined in the study protocol.
|
|
Infections and infestations
Ear infection
|
7.7%
3/39 • Adverse events were collected for the duration of the study. The safety population includes all patients who were exposed to the study drug.
An adverse event was considered to be any untoward medical occurrence in the health of a patient who was exposed to study medication, regardless of causal relationship with the study medication. Adverse events were obtained as solicited comments from the study patients and as observations by the study Investigator as outlined in the study protocol.
|
2.5%
1/40 • Adverse events were collected for the duration of the study. The safety population includes all patients who were exposed to the study drug.
An adverse event was considered to be any untoward medical occurrence in the health of a patient who was exposed to study medication, regardless of causal relationship with the study medication. Adverse events were obtained as solicited comments from the study patients and as observations by the study Investigator as outlined in the study protocol.
|
|
Infections and infestations
Sinusitis
|
5.1%
2/39 • Adverse events were collected for the duration of the study. The safety population includes all patients who were exposed to the study drug.
An adverse event was considered to be any untoward medical occurrence in the health of a patient who was exposed to study medication, regardless of causal relationship with the study medication. Adverse events were obtained as solicited comments from the study patients and as observations by the study Investigator as outlined in the study protocol.
|
0.00%
0/40 • Adverse events were collected for the duration of the study. The safety population includes all patients who were exposed to the study drug.
An adverse event was considered to be any untoward medical occurrence in the health of a patient who was exposed to study medication, regardless of causal relationship with the study medication. Adverse events were obtained as solicited comments from the study patients and as observations by the study Investigator as outlined in the study protocol.
|
|
Investigations
Intraocular pressure increased
|
5.1%
2/39 • Adverse events were collected for the duration of the study. The safety population includes all patients who were exposed to the study drug.
An adverse event was considered to be any untoward medical occurrence in the health of a patient who was exposed to study medication, regardless of causal relationship with the study medication. Adverse events were obtained as solicited comments from the study patients and as observations by the study Investigator as outlined in the study protocol.
|
2.5%
1/40 • Adverse events were collected for the duration of the study. The safety population includes all patients who were exposed to the study drug.
An adverse event was considered to be any untoward medical occurrence in the health of a patient who was exposed to study medication, regardless of causal relationship with the study medication. Adverse events were obtained as solicited comments from the study patients and as observations by the study Investigator as outlined in the study protocol.
|
|
Surgical and medical procedures
Cataract operation (non-study eye)
|
7.7%
3/39 • Adverse events were collected for the duration of the study. The safety population includes all patients who were exposed to the study drug.
An adverse event was considered to be any untoward medical occurrence in the health of a patient who was exposed to study medication, regardless of causal relationship with the study medication. Adverse events were obtained as solicited comments from the study patients and as observations by the study Investigator as outlined in the study protocol.
|
15.0%
6/40 • Adverse events were collected for the duration of the study. The safety population includes all patients who were exposed to the study drug.
An adverse event was considered to be any untoward medical occurrence in the health of a patient who was exposed to study medication, regardless of causal relationship with the study medication. Adverse events were obtained as solicited comments from the study patients and as observations by the study Investigator as outlined in the study protocol.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER