Trial Outcomes & Findings for Study to Evaluate the Safety for the Treatment of Inflammation Associated With Cataract Surgery (NCT NCT02547623)
NCT ID: NCT02547623
Last Updated: 2018-08-21
Results Overview
Treatment-emergent Adverse Events were defined as events that started after the study drug administration, and occurred before termination of the study, or were present before study drug administration and worsened after dose administration.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
194 participants
Primary outcome timeframe
Baseline to postoperative day 90/ early termination
Results posted on
2018-08-21
Participant Flow
The first patient was enrolled into the study on 06 November 2015 and the last patient completed the study on 16 August 2016.
Of the 194 patients randomized, 181 patients were dosed and included in the ITT (intent-to-treat) and safety analysis sets. 13 randomized patients were not dosed and terminated from the study. Some of the patients that were not dosed had at least one significant protocol deviation.
Participant milestones
| Measure |
Dexamethasone Depot
A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery
|
Prednisolone Drops 1% (Standard of Care)
Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
|
|---|---|---|
|
Overall Study
STARTED
|
126
|
55
|
|
Overall Study
COMPLETED
|
122
|
52
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate the Safety for the Treatment of Inflammation Associated With Cataract Surgery
Baseline characteristics by cohort
| Measure |
Dexamethasone Depot
n=126 Participants
A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery
|
Prednisolone Drops 1% (Standard of Care)
n=55 Participants
Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
|
Total
n=181 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
92 Participants
n=93 Participants
|
38 Participants
n=4 Participants
|
130 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
98 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
83 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
117 Participants
n=93 Participants
|
54 Participants
n=4 Participants
|
171 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
111 Participants
n=93 Participants
|
52 Participants
n=4 Participants
|
163 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
126 Participants
n=93 Participants
|
55 Participants
n=4 Participants
|
181 Participants
n=27 Participants
|
|
Study Eye
OD (Right eye)
|
67 study eye
n=93 Participants
|
27 study eye
n=4 Participants
|
94 study eye
n=27 Participants
|
|
Study Eye
OS (Left eye)
|
59 study eye
n=93 Participants
|
28 study eye
n=4 Participants
|
87 study eye
n=27 Participants
|
|
Best Corrected Visual Acuity
study eye number
|
.292 LogMar
STANDARD_DEVIATION .1913 • n=93 Participants
|
.355 LogMar
STANDARD_DEVIATION .2557 • n=4 Participants
|
.311 LogMar
STANDARD_DEVIATION .2141 • n=27 Participants
|
|
Best Corrected Visual Acuity
fellow eye number
|
.126 LogMar
STANDARD_DEVIATION .1394 • n=93 Participants
|
.176 LogMar
STANDARD_DEVIATION .2123 • n=4 Participants
|
.141 LogMar
STANDARD_DEVIATION .1660 • n=27 Participants
|
|
Corneal Endothelial Cell Density - Specular Microscopy
|
2491.91 cells/mm^2
STANDARD_DEVIATION 346.365 • n=93 Participants
|
2398.33 cells/mm^2
STANDARD_DEVIATION 384.092 • n=4 Participants
|
2463.15 cells/mm^2
STANDARD_DEVIATION 359.902 • n=27 Participants
|
|
Intraocular Pressure
Study eye
|
15.1 mmHg
STANDARD_DEVIATION 2.94 • n=93 Participants
|
14.4 mmHg
STANDARD_DEVIATION 2.71 • n=4 Participants
|
14.9 mmHg
STANDARD_DEVIATION 2.88 • n=27 Participants
|
|
Intraocular Pressure
Fellow eye
|
14.9 mmHg
STANDARD_DEVIATION 2.88 • n=93 Participants
|
14.5 mmHg
STANDARD_DEVIATION 2.79 • n=4 Participants
|
14.8 mmHg
STANDARD_DEVIATION 2.85 • n=27 Participants
|
|
Use of Viscoelastic during the Surgery
Yes
|
126 Participants
n=93 Participants
|
55 Participants
n=4 Participants
|
181 Participants
n=27 Participants
|
|
Use of Viscoelastic during the Surgery
No
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Use of Femto prior to the Surgery
Yes
|
25 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Use of Femto prior to the Surgery
No
|
101 Participants
n=93 Participants
|
47 Participants
n=4 Participants
|
148 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline to postoperative day 90/ early terminationTreatment-emergent Adverse Events were defined as events that started after the study drug administration, and occurred before termination of the study, or were present before study drug administration and worsened after dose administration.
Outcome measures
| Measure |
Dexamethasone Depot
n=126 Participants
A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery
|
Prednisolone Drops 1% (Standard of Care)
n=55 Participants
Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Ocular events: study eye · Any TEAE
|
53 Participants
|
13 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Ocular events: study eye · Serious TEAE
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Systemic events · Any TEAE
|
10 Participants
|
6 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Ocular events: study eye · No TEAE
|
72 Participants
|
42 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Ocular events: fellow eye · Any TEAE
|
12 Participants
|
4 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Ocular events: fellow eye · Serious TEAE
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Ocular events: fellow eye · No TEAE
|
114 Participants
|
51 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Systemic events · Serious TEAE
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Systemic events · No TEAE
|
114 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early terminationIntraocular Pressure was measured by Goldmann applanation tonometry.
Outcome measures
| Measure |
Dexamethasone Depot
n=126 Participants
A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery
|
Prednisolone Drops 1% (Standard of Care)
n=55 Participants
Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
|
|---|---|---|
|
Intraocular Pressure Measurement
Screening (Baseline)
|
15.1 mmHG
Standard Deviation 2.94
|
14.4 mmHG
Standard Deviation 2.71
|
|
Intraocular Pressure Measurement
Post Operative Day 1
|
19.1 mmHG
Standard Deviation 6.54
|
17.5 mmHG
Standard Deviation 6.44
|
|
Intraocular Pressure Measurement
Post Operative Day 8
|
15.0 mmHG
Standard Deviation 4.7
|
15.1 mmHG
Standard Deviation 3.64
|
|
Intraocular Pressure Measurement
Post Operative Day 30
|
13.8 mmHG
Standard Deviation 3.2
|
14.1 mmHG
Standard Deviation 3.57
|
|
Intraocular Pressure Measurement
Post Operative Day 90/End of Treatment
|
13.0 mmHG
Standard Deviation 2.89
|
12.7 mmHG
Standard Deviation 2.93
|
SECONDARY outcome
Timeframe: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early terminationVisual Acuity assessed by the Snellen chart, was expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1
Outcome measures
| Measure |
Dexamethasone Depot
n=126 Participants
A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery
|
Prednisolone Drops 1% (Standard of Care)
n=55 Participants
Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
|
|---|---|---|
|
Visual Acuity in Study Eye
Screening (Baseline)
|
.292 LogMar
Standard Deviation 0.1913
|
.355 LogMar
Standard Deviation .2557
|
|
Visual Acuity in Study Eye
Post Operative Day 1
|
.249 LogMar
Standard Deviation .1398
|
.327 LogMar
Standard Deviation .2129
|
|
Visual Acuity in Study Eye
Post Operative Day 8
|
.073 LogMar
Standard Deviation .1353
|
.073 LogMar
Standard Deviation .1746
|
|
Visual Acuity in Study Eye
Post Operative Day 30
|
.039 LogMar
Standard Deviation .0952
|
.040 LogMar
Standard Deviation .1350
|
|
Visual Acuity in Study Eye
Post Operative Day 90/End of Treatment
|
.040 LogMar
Standard Deviation .1012
|
.047 LogMar
Standard Deviation .1150
|
SECONDARY outcome
Timeframe: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early terminationSlit lamp biomicroscopy of the anterior chamber was performed using a slit beam of 1-mm height and 1-mm width with maximum luminance through the highest-powered lens using the Investigator's standard slit lamp equipment and procedure. Conjunctiva hyperemia slit lamp results were summarized by treatment group and time point.
Outcome measures
| Measure |
Dexamethasone Depot
n=126 Participants
A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery
|
Prednisolone Drops 1% (Standard of Care)
n=55 Participants
Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
|
|---|---|---|
|
Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade
Postoperative day 8 · 1 (Mild)
|
11 Participants
|
8 Participants
|
|
Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade
Postoperative day 8 · 2 (Moderate)
|
0 Participants
|
0 Participants
|
|
Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade
Postoperative day 8 · No value
|
0 Participants
|
2 Participants
|
|
Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade
Postoperative day 30 · 3 (Severe)
|
0 Participants
|
0 Participants
|
|
Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade
Postoperative day 30 · No value
|
3 Participants
|
3 Participants
|
|
Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade
Baseline · 0 (Absent)
|
124 Participants
|
55 Participants
|
|
Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade
Baseline · 1 (Mild)
|
1 Participants
|
0 Participants
|
|
Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade
Baseline · 2 (Moderate)
|
1 Participants
|
0 Participants
|
|
Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade
Baseline · 3 (Severe)
|
0 Participants
|
0 Participants
|
|
Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade
Baseline · No value
|
0 Participants
|
0 Participants
|
|
Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade
Postoperative day 1 · 0 (Absent)
|
103 Participants
|
45 Participants
|
|
Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade
Postoperative day 1 · 1 (Mild)
|
21 Participants
|
10 Participants
|
|
Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade
Postoperative day 1 · 2 (Moderate)
|
2 Participants
|
0 Participants
|
|
Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade
Postoperative day 1 · 3 (Severe)
|
0 Participants
|
0 Participants
|
|
Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade
Postoperative day 1 · No value
|
0 Participants
|
0 Participants
|
|
Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade
Postoperative day 8 · 0 (Absent)
|
115 Participants
|
45 Participants
|
|
Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade
Postoperative day 8 · 3 (Severe)
|
0 Participants
|
0 Participants
|
|
Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade
Postoperative day 30 · 0 (Absent)
|
107 Participants
|
44 Participants
|
|
Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade
Postoperative day 30 · 1 (Mild)
|
14 Participants
|
8 Participants
|
|
Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade
Postoperative day 30 · 2 (Moderate)
|
2 Participants
|
0 Participants
|
|
Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade
Postoperative day 90/End of Treatment · 0 (Absent)
|
119 Participants
|
50 Participants
|
|
Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade
Postoperative day 90/End of Treatment · 1 (Mild)
|
4 Participants
|
2 Participants
|
|
Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade
Postoperative day 90/End of Treatment · 2 (Moderate)
|
0 Participants
|
0 Participants
|
|
Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade
Postoperative day 90/End of Treatment · 3 (Severe)
|
0 Participants
|
0 Participants
|
|
Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade
Postoperative day 90/End of Treatment · No value
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early terminationSlit lamp biomicroscopy of the anterior chamber was performed using a slit beam of 1-mm height and 1-mm width with maximum luminance through the highest-powered lens using the Investigator's standard slit lamp equipment and procedure. Cornea edema slit lamp results in the study eye were summarized by treatment group and time point.
Outcome measures
| Measure |
Dexamethasone Depot
n=126 Participants
A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery
|
Prednisolone Drops 1% (Standard of Care)
n=55 Participants
Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
|
|---|---|---|
|
Slit Lamp Biomicroscopy - Cornea Edema Grade
Baseline · No value
|
0 Participants
|
1 Participants
|
|
Slit Lamp Biomicroscopy - Cornea Edema Grade
Postoperative day 1 · 0 (Absent)
|
74 Participants
|
37 Participants
|
|
Slit Lamp Biomicroscopy - Cornea Edema Grade
Postoperative day 1 · 2 (Moderate)
|
9 Participants
|
3 Participants
|
|
Slit Lamp Biomicroscopy - Cornea Edema Grade
Postoperative day 1 · 3 (Severe)
|
0 Participants
|
0 Participants
|
|
Slit Lamp Biomicroscopy - Cornea Edema Grade
Postoperative day 1 · No value
|
0 Participants
|
0 Participants
|
|
Slit Lamp Biomicroscopy - Cornea Edema Grade
Postoperative day 8 · 0 (Absent)
|
109 Participants
|
48 Participants
|
|
Slit Lamp Biomicroscopy - Cornea Edema Grade
Postoperative day 8 · 1 (Mild)
|
16 Participants
|
6 Participants
|
|
Slit Lamp Biomicroscopy - Cornea Edema Grade
Postoperative day 8 · 2 (Moderate)
|
0 Participants
|
0 Participants
|
|
Slit Lamp Biomicroscopy - Cornea Edema Grade
Postoperative day 8 · 3 (Severe)
|
0 Participants
|
0 Participants
|
|
Slit Lamp Biomicroscopy - Cornea Edema Grade
Postoperative day 8 · No value
|
1 Participants
|
1 Participants
|
|
Slit Lamp Biomicroscopy - Cornea Edema Grade
Postoperative day 30 · 0 (Absent)
|
121 Participants
|
52 Participants
|
|
Slit Lamp Biomicroscopy - Cornea Edema Grade
Postoperative day 30 · 1 (Mild)
|
0 Participants
|
0 Participants
|
|
Slit Lamp Biomicroscopy - Cornea Edema Grade
Postoperative day 30 · 2 (Moderate)
|
2 Participants
|
0 Participants
|
|
Slit Lamp Biomicroscopy - Cornea Edema Grade
Postoperative day 30 · 3 (Severe)
|
0 Participants
|
0 Participants
|
|
Slit Lamp Biomicroscopy - Cornea Edema Grade
Postoperative day 30 · No value
|
3 Participants
|
3 Participants
|
|
Slit Lamp Biomicroscopy - Cornea Edema Grade
Postoperative day 90/End of Treatment · 0 (Absent)
|
123 Participants
|
52 Participants
|
|
Slit Lamp Biomicroscopy - Cornea Edema Grade
Postoperative day 90/End of Treatment · 1 (Mild)
|
0 Participants
|
0 Participants
|
|
Slit Lamp Biomicroscopy - Cornea Edema Grade
Postoperative day 90/End of Treatment · 2 (Moderate)
|
0 Participants
|
0 Participants
|
|
Slit Lamp Biomicroscopy - Cornea Edema Grade
Postoperative day 90/End of Treatment · 3 (Severe)
|
0 Participants
|
0 Participants
|
|
Slit Lamp Biomicroscopy - Cornea Edema Grade
Postoperative day 90/End of Treatment · No value
|
3 Participants
|
3 Participants
|
|
Slit Lamp Biomicroscopy - Cornea Edema Grade
Baseline · 0 (Absent)
|
126 Participants
|
54 Participants
|
|
Slit Lamp Biomicroscopy - Cornea Edema Grade
Baseline · 1 (Mild)
|
0 Participants
|
0 Participants
|
|
Slit Lamp Biomicroscopy - Cornea Edema Grade
Baseline · 2 (Moderate)
|
0 Participants
|
0 Participants
|
|
Slit Lamp Biomicroscopy - Cornea Edema Grade
Baseline · 3 (Severe)
|
0 Participants
|
0 Participants
|
|
Slit Lamp Biomicroscopy - Cornea Edema Grade
Postoperative day 1 · 1 (Mild)
|
43 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early terminationOutcome measures
| Measure |
Dexamethasone Depot
n=126 Participants
A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery
|
Prednisolone Drops 1% (Standard of Care)
n=55 Participants
Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
|
|---|---|---|
|
Summary of Concomitant Medications Used in the Study Eye or Both Eyes
Patients reporting at least one concomitant medica
|
124 Participants
|
55 Participants
|
|
Summary of Concomitant Medications Used in the Study Eye or Both Eyes
Antiseptics and disinfectants
|
1 Participants
|
1 Participants
|
|
Summary of Concomitant Medications Used in the Study Eye or Both Eyes
Anesthetics
|
4 Participants
|
1 Participants
|
|
Summary of Concomitant Medications Used in the Study Eye or Both Eyes
Psycholeptics
|
2 Participants
|
1 Participants
|
|
Summary of Concomitant Medications Used in the Study Eye or Both Eyes
Ophthalmologicals
|
124 Participants
|
55 Participants
|
|
Summary of Concomitant Medications Used in the Study Eye or Both Eyes
Thyroid therapy
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Postoperative day 90/Early terminationCorneal Endothelial Cell Density was measured by specular microscopy.
Outcome measures
| Measure |
Dexamethasone Depot
n=126 Participants
A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery
|
Prednisolone Drops 1% (Standard of Care)
n=55 Participants
Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
|
|---|---|---|
|
Changes in the Corneal Endothelial Cell Count
Baseline
|
2483.66 cells/mm^2
Standard Deviation 351.819
|
2398.33 cells/mm^2
Standard Deviation 384.092
|
|
Changes in the Corneal Endothelial Cell Count
Postoperative day 90/End of treatment
|
2141.77 cells/mm^2
Standard Deviation 522.327
|
2106.39 cells/mm^2
Standard Deviation 517.938
|
|
Changes in the Corneal Endothelial Cell Count
Change from Baseline
|
-334.60 cells/mm^2
Standard Deviation 415.071
|
-288.83 cells/mm^2
Standard Deviation 376.775
|
SECONDARY outcome
Timeframe: Baseline, POD 90/Early terminationCalculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc).
Outcome measures
| Measure |
Dexamethasone Depot
n=126 Participants
A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery
|
Prednisolone Drops 1% (Standard of Care)
n=55 Participants
Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
|
|---|---|---|
|
Optic Disc Cup-disc Ratio for the Study Eye
Screening (Baseline)
|
.31 ratio
Standard Deviation .142
|
.32 ratio
Standard Deviation .135
|
|
Optic Disc Cup-disc Ratio for the Study Eye
Postoperative day 90/End of treatment
|
.31 ratio
Standard Deviation .131
|
.33 ratio
Standard Deviation .143
|
SECONDARY outcome
Timeframe: Baseline, POD 90/Early terminationThe number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's optic disc
Outcome measures
| Measure |
Dexamethasone Depot
n=126 Participants
A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery
|
Prednisolone Drops 1% (Standard of Care)
n=55 Participants
Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
|
|---|---|---|
|
Dilated Opthalmoscopy Findings - Optic Disc (Study Eye)
Screening (Baseline) · Normal
|
115 Participants
|
52 Participants
|
|
Dilated Opthalmoscopy Findings - Optic Disc (Study Eye)
Screening (Baseline) · Abnormal
|
2 Participants
|
1 Participants
|
|
Dilated Opthalmoscopy Findings - Optic Disc (Study Eye)
Screening (Baseline) · Not analyzed
|
9 Participants
|
2 Participants
|
|
Dilated Opthalmoscopy Findings - Optic Disc (Study Eye)
Postoperative day 90/End of treatment · Normal
|
119 Participants
|
50 Participants
|
|
Dilated Opthalmoscopy Findings - Optic Disc (Study Eye)
Postoperative day 90/End of treatment · Abnormal
|
2 Participants
|
1 Participants
|
|
Dilated Opthalmoscopy Findings - Optic Disc (Study Eye)
Postoperative day 90/End of treatment · Not analyzed
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline, POD 90/Early terminationThe number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's retina
Outcome measures
| Measure |
Dexamethasone Depot
n=126 Participants
A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery
|
Prednisolone Drops 1% (Standard of Care)
n=55 Participants
Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
|
|---|---|---|
|
Dilated Opthalmoscopy Findings - Retina (Study Eye)
Postoperative day 90/End of treatment · Abnormal
|
5 Participants
|
1 Participants
|
|
Dilated Opthalmoscopy Findings - Retina (Study Eye)
Postoperative day 90/End of treatment · Not analyzed
|
3 Participants
|
4 Participants
|
|
Dilated Opthalmoscopy Findings - Retina (Study Eye)
Screening (Baseline) · Normal
|
120 Participants
|
51 Participants
|
|
Dilated Opthalmoscopy Findings - Retina (Study Eye)
Screening (Baseline) · Abnormal
|
5 Participants
|
4 Participants
|
|
Dilated Opthalmoscopy Findings - Retina (Study Eye)
Screening (Baseline) · Not analyzed
|
1 Participants
|
0 Participants
|
|
Dilated Opthalmoscopy Findings - Retina (Study Eye)
Postoperative day 90/End of treatment · Normal
|
118 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: Baseline, POD 90/Early terminationThe number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's macula.
Outcome measures
| Measure |
Dexamethasone Depot
n=126 Participants
A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery
|
Prednisolone Drops 1% (Standard of Care)
n=55 Participants
Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
|
|---|---|---|
|
Dilated Opthalmoscopy Findings - Macula (Study Eye)
Screening (Baseline) · Normal
|
109 Participants
|
44 Participants
|
|
Dilated Opthalmoscopy Findings - Macula (Study Eye)
Screening (Baseline) · Abnormal
|
15 Participants
|
11 Participants
|
|
Dilated Opthalmoscopy Findings - Macula (Study Eye)
Screening (Baseline) · Not analyzed
|
2 Participants
|
0 Participants
|
|
Dilated Opthalmoscopy Findings - Macula (Study Eye)
Postoperative day 90/End of treatment · Normal
|
107 Participants
|
39 Participants
|
|
Dilated Opthalmoscopy Findings - Macula (Study Eye)
Postoperative day 90/End of treatment · Abnormal
|
16 Participants
|
12 Participants
|
|
Dilated Opthalmoscopy Findings - Macula (Study Eye)
Postoperative day 90/End of treatment · Not analyzed
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline, POD 90/Early terminationThe number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's choroid
Outcome measures
| Measure |
Dexamethasone Depot
n=126 Participants
A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery
|
Prednisolone Drops 1% (Standard of Care)
n=55 Participants
Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
|
|---|---|---|
|
Dilated Opthalmoscopy Findings - Choroid (Study Eye)
Screening (Baseline) · Normal
|
124 Participants
|
54 Participants
|
|
Dilated Opthalmoscopy Findings - Choroid (Study Eye)
Screening (Baseline) · Abnormal
|
0 Participants
|
0 Participants
|
|
Dilated Opthalmoscopy Findings - Choroid (Study Eye)
Screening (Baseline) · Not analyzed
|
2 Participants
|
1 Participants
|
|
Dilated Opthalmoscopy Findings - Choroid (Study Eye)
Postoperative day 90/End of treatment · Normal
|
122 Participants
|
50 Participants
|
|
Dilated Opthalmoscopy Findings - Choroid (Study Eye)
Postoperative day 90/End of treatment · Abnormal
|
1 Participants
|
0 Participants
|
|
Dilated Opthalmoscopy Findings - Choroid (Study Eye)
Postoperative day 90/End of treatment · Not analyzed
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline, POD 90/Early terminationThe number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's vitreous
Outcome measures
| Measure |
Dexamethasone Depot
n=126 Participants
A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery
|
Prednisolone Drops 1% (Standard of Care)
n=55 Participants
Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
|
|---|---|---|
|
Dilated Opthalmoscopy Findings - Vitreous (Study Eye)
Screening (Baseline) · Normal
|
104 Participants
|
49 Participants
|
|
Dilated Opthalmoscopy Findings - Vitreous (Study Eye)
Screening (Baseline) · Abnormal
|
21 Participants
|
5 Participants
|
|
Dilated Opthalmoscopy Findings - Vitreous (Study Eye)
Screening (Baseline) · Not analyzed
|
1 Participants
|
1 Participants
|
|
Dilated Opthalmoscopy Findings - Vitreous (Study Eye)
Postoperative day 90/End of treatment · Normal
|
107 Participants
|
44 Participants
|
|
Dilated Opthalmoscopy Findings - Vitreous (Study Eye)
Postoperative day 90/End of treatment · Abnormal
|
16 Participants
|
7 Participants
|
|
Dilated Opthalmoscopy Findings - Vitreous (Study Eye)
Postoperative day 90/End of treatment · Not analyzed
|
3 Participants
|
4 Participants
|
Adverse Events
Dexamethasone Depot
Serious events: 3 serious events
Other events: 23 other events
Deaths: 0 deaths
Prednisolone Drops 1% (Standard of Care)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dexamethasone Depot
n=126 participants at risk
A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery
|
Prednisolone Drops 1% (Standard of Care)
n=55 participants at risk
Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
|
|---|---|---|
|
Eye disorders
Diabetic retinopathy
|
0.79%
1/126 • Adverse event data was collected from screening until postoperative day 90/end of treatment.
|
0.00%
0/55 • Adverse event data was collected from screening until postoperative day 90/end of treatment.
|
|
Nervous system disorders
Loss of consciousness
|
0.79%
1/126 • Adverse event data was collected from screening until postoperative day 90/end of treatment.
|
0.00%
0/55 • Adverse event data was collected from screening until postoperative day 90/end of treatment.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.79%
1/126 • Adverse event data was collected from screening until postoperative day 90/end of treatment.
|
0.00%
0/55 • Adverse event data was collected from screening until postoperative day 90/end of treatment.
|
Other adverse events
| Measure |
Dexamethasone Depot
n=126 participants at risk
A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery
|
Prednisolone Drops 1% (Standard of Care)
n=55 participants at risk
Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
|
|---|---|---|
|
Investigations
Intraocular pressure increased
|
11.1%
14/126 • Adverse event data was collected from screening until postoperative day 90/end of treatment.
|
3.6%
2/55 • Adverse event data was collected from screening until postoperative day 90/end of treatment.
|
|
Eye disorders
Iritis
|
6.3%
8/126 • Adverse event data was collected from screening until postoperative day 90/end of treatment.
|
0.00%
0/55 • Adverse event data was collected from screening until postoperative day 90/end of treatment.
|
|
Nervous system disorders
Headache
|
0.79%
1/126 • Adverse event data was collected from screening until postoperative day 90/end of treatment.
|
7.3%
4/55 • Adverse event data was collected from screening until postoperative day 90/end of treatment.
|
Additional Information
Vice President, Quality and Compliance
Icon Bioscience, Inc.
Phone: 510-933-8381
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place