Study to Evaluate the Safety for the Treatment of Inflammation Associated With Cataract Surgery

• Sponsor: ICON Bioscience Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02547623
• Collaborator: (none)
• Enrollment: 194
• Locations: 11
• Arms: 2
• Actual Duration (Months): 9.3
• Patients Per Site: 17.6
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

The study is a prospective, randomized, parallel-design, multicenter trial in patients ≥40 years of age undergoing cataract surgery. Patients who meet all inclusion and no exclusion criteria will be randomized to 1 of 2 treatment groups

• A single 5 mcl anterior chamber injection of IBI 10090, 103.4 mcg/mcl dexamethasone, equivalent dexamethasone dose: 517 mcg at the conclusion of cataract surgery or;

• Prednisolone acetate ophthalmic suspension 1% eye drops administered 1 drop 4 times daily (QID) for 3 weeks Safety will be assessed by adverse events (AEs), slit lamp biomicroscopy, fundus examination, intraocular pressure (IOP), visual acuity, and specular microscopy endothelial cell count.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Drug: Dexamethasone; Drug: Prednisolone	Phase 3

Detailed Description

The study is a prospective, randomized, parallel-design, multicenter trial in patients ≥40 years of age undergoing cataract surgery. Patients who meet all inclusion and no exclusion criteria will be randomized to 1 of 2 treatment groups

• A single 5 mcl anterior chamber injection of IBI 10090, 103.4 mcg/mcl dexamethasone, equivalent dexamethasone dose: 517 mcg at the conclusion of cataract surgery or;

• Prednisolone acetate ophthalmic suspension 1% eye drops administered 1 drop 4 times daily (QID) for 3 weeks

Study Design

• Study Type: Interventional
• Actual Enrollment: 194 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Prospective, Randomized, Parallel-design, Multicenter Study to Evaluate the Safety of Icon Bioscience-10090 for the Treatment of Inflammation Associated With Cataract Surgery
• Actual Study Start Date: Nov 6, 2015
• Actual Primary Completion Date: Aug 16, 2016
• Actual Study Completion Date: Aug 16, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: dexamethasone depot dexamethasone depot 517 mcg	Drug: Dexamethasone; depot intracameral; Other Names: Dexycu
Active Comparator: standard of care prednisolone drops 1%	Drug: Prednisolone; Prednisolone eye drops 1%; Other Names: standard of care

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Baseline to postoperative day 90/ early termination]

   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.

Secondary Outcome Measures

1. Intraocular Pressure Measurement [Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination]

   Intraocular Pressure was measured by Goldmann applanation tonometry.

2. Visual Acuity in Study Eye [Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination]

   Visual 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

3. Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade [Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination]

   Slit 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.

4. Slit Lamp Biomicroscopy - Cornea Edema Grade [Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination]

   Slit 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.

5. Summary of Concomitant Medications Used in the Study Eye or Both Eyes [Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination]

6. Changes in the Corneal Endothelial Cell Count [Baseline, Postoperative day 90/Early termination]

   Corneal Endothelial Cell Density was measured by specular microscopy.

7. Optic Disc Cup-disc Ratio for the Study Eye [Baseline, POD 90/Early termination]

   Calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc).

8. Dilated Opthalmoscopy Findings - Optic Disc (Study Eye) [Baseline, POD 90/Early termination]

   The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's optic disc

9. Dilated Opthalmoscopy Findings - Retina (Study Eye) [Baseline, POD 90/Early termination]

   The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's retina

10. Dilated Opthalmoscopy Findings - Macula (Study Eye) [Baseline, POD 90/Early termination]

    The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's macula.

11. Dilated Opthalmoscopy Findings - Choroid (Study Eye) [Baseline, POD 90/Early termination]

    The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's choroid

12. Dilated Opthalmoscopy Findings - Vitreous (Study Eye) [Baseline, POD 90/Early termination]

    The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's vitreous

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• undergoing cataract surgery

Exclusion Criteria:

• glaucoma patient, pregnancy, allergy to dexamethasone

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kislinger MD inc	Glendora	California	United States	91741
2	Inland Eye Specialists	Hemet	California	United States	92545
3	Harvard Eye Associated	Laguna Hills	California	United States	92653
4	Feinerman Vision Center	Newport Beach	California	United States	92663
5	Cincinnati Eye Institute	Edgewood	Kentucky	United States	41017
6	Associated Eye Care	Stillwater	Minnesota	United States	55082
7	Matossian Eye Associates	Pennington	New Jersey	United States	08534
8	Ophthalmic Consultants of Long Island	Garden City	New York	United States	11530
9	Cincinnati Eye Institute	Cincinnati	Ohio	United States	45242
10	Carolina Eye Care Physicians	Mount Pleasant	South Carolina	United States	29464
11	the eye institute of Utah	Salt Lake City	Utah	United States	84107

Sponsors and Collaborators

• ICON Bioscience Inc

Investigators

• Principal Investigator: Eric Donnenfeld, MD, Ophthalmic Consultants of Long Island

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ICON Bioscience Inc
• ClinicalTrials.gov Identifier: NCT02547623
• Other Study ID Numbers: C15-01
• First Posted: Sep 11, 2015
• Last Update Posted: Aug 21, 2018
• Last Verified: Jul 1, 2018

• Additional relevant MeSH terms: Cataract; Inflammation; Dexamethasone; Prednisolone

Study Results

Participant Flow

Recruitment Details	The first patient was enrolled into the study on 06 November 2015 and the last patient completed the study on 16 August 2016.
Pre-assignment Detail	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.

Arm/Group Title	Dexamethasone Depot	Prednisolone Drops 1% (Standard of Care)
Arm/Group Description	A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery	Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
Period Title: Overall Study
STARTED	126	55
COMPLETED	122	52
NOT COMPLETED	4	3

Baseline Characteristics

Arm/Group Title	Dexamethasone Depot	Prednisolone Drops 1% (Standard of Care)	Total
Arm/Group Description	A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery	Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)	Total of all reporting groups
Overall Participants	126	55	181
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	34 27%	17 30.9%	51 28.2%
>=65 years	92 73%	38 69.1%	130 71.8%
Sex: Female, Male (Count of Participants)
Female	67 53.2%	31 56.4%	98 54.1%
Male	59 46.8%	24 43.6%	83 45.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	9 7.1%	1 1.8%	10 5.5%
Not Hispanic or Latino	117 92.9%	54 98.2%	171 94.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 0.8%	2 3.6%	3 1.7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	11 8.7%	1 1.8%	12 6.6%
White	111 88.1%	52 94.5%	163 90.1%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	3 2.4%	0 0%	3 1.7%
Region of Enrollment (Count of Participants)
United States	126 100%	55 100%	181 100%
Study Eye (study eye) [Number]
OD (Right eye)	67	27	94
OS (Left eye)	59	28	87
Best Corrected Visual Acuity (LogMar) [Mean (Standard Deviation) ]
study eye number	.292 (.1913)	.355 (.2557)	.311 (.2141)
fellow eye number	.126 (.1394)	.176 (.2123)	.141 (.1660)
Corneal Endothelial Cell Density - Specular Microscopy (cells/mm^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cells/mm^2]	2491.91 (346.365)	2398.33 (384.092)	2463.15 (359.902)
Intraocular Pressure (mmHg) [Mean (Standard Deviation) ]
Study eye	15.1 (2.94)	14.4 (2.71)	14.9 (2.88)
Fellow eye	14.9 (2.88)	14.5 (2.79)	14.8 (2.85)
Use of Viscoelastic during the Surgery (Count of Participants)
Yes	126 100%	55 100%	181 100%
No	0 0%	0 0%	0 0%
Use of Femto prior to the Surgery (Count of Participants)
Yes	25 19.8%	8 14.5%	33 18.2%
No	101 80.2%	47 85.5%	148 81.8%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Description	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.
Time Frame	Baseline to postoperative day 90/ early termination

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone Depot	Prednisolone Drops 1% (Standard of Care)
Arm/Group Description	A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery	Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
Measure Participants	126	55
Any TEAE	53 42.1%	13 23.6%
Serious TEAE	1 0.8%	0 0%
No TEAE	72 57.1%	42 76.4%
Any TEAE	12 9.5%	4 7.3%
Serious TEAE	0 0%	0 0%
No TEAE	114 90.5%	51 92.7%
Any TEAE	10 7.9%	6 10.9%
Serious TEAE	2 1.6%	0 0%
No TEAE	114 90.5%	49 89.1%

2. Secondary Outcome

Title	Intraocular Pressure Measurement
Description	Intraocular Pressure was measured by Goldmann applanation tonometry.
Time Frame	Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone Depot	Prednisolone Drops 1% (Standard of Care)
Arm/Group Description	A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery	Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
Measure Participants	126	55
Screening (Baseline)	15.1 (2.94)	14.4 (2.71)
Post Operative Day 1	19.1 (6.54)	17.5 (6.44)
Post Operative Day 8	15.0 (4.7)	15.1 (3.64)
Post Operative Day 30	13.8 (3.2)	14.1 (3.57)
Post Operative Day 90/End of Treatment	13.0 (2.89)	12.7 (2.93)

3. Secondary Outcome

Title	Visual Acuity in Study Eye
Description	Visual 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
Time Frame	Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone Depot	Prednisolone Drops 1% (Standard of Care)
Arm/Group Description	A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery	Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
Measure Participants	126	55
Screening (Baseline)	.292 (0.1913)	.355 (.2557)
Post Operative Day 1	.249 (.1398)	.327 (.2129)
Post Operative Day 8	.073 (.1353)	.073 (.1746)
Post Operative Day 30	.039 (.0952)	.040 (.1350)
Post Operative Day 90/End of Treatment	.040 (.1012)	.047 (.1150)

4. Secondary Outcome

Title	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade
Description	Slit 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.
Time Frame	Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone Depot	Prednisolone Drops 1% (Standard of Care)
Arm/Group Description	A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery	Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
Measure Participants	126	55
0 (Absent)	124 98.4%	55 100%
1 (Mild)	1 0.8%	0 0%
2 (Moderate)	1 0.8%	0 0%
3 (Severe)	0 0%	0 0%
No value	0 0%	0 0%
0 (Absent)	103 81.7%	45 81.8%
1 (Mild)	21 16.7%	10 18.2%
2 (Moderate)	2 1.6%	0 0%
3 (Severe)	0 0%	0 0%
No value	0 0%	0 0%
0 (Absent)	115 91.3%	45 81.8%
1 (Mild)	11 8.7%	8 14.5%
2 (Moderate)	0 0%	0 0%
3 (Severe)	0 0%	0 0%
No value	0 0%	2 3.6%
0 (Absent)	107 84.9%	44 80%
1 (Mild)	14 11.1%	8 14.5%
2 (Moderate)	2 1.6%	0 0%
3 (Severe)	0 0%	0 0%
No value	3 2.4%	3 5.5%
0 (Absent)	119 94.4%	50 90.9%
1 (Mild)	4 3.2%	2 3.6%
2 (Moderate)	0 0%	0 0%
3 (Severe)	0 0%	0 0%
No value	3 2.4%	3 5.5%

5. Secondary Outcome

Title	Slit Lamp Biomicroscopy - Cornea Edema Grade
Description	Slit 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.
Time Frame	Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone Depot	Prednisolone Drops 1% (Standard of Care)
Arm/Group Description	A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery	Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
Measure Participants	126	55
0 (Absent)	126 100%	54 98.2%
1 (Mild)	0 0%	0 0%
2 (Moderate)	0 0%	0 0%
3 (Severe)	0 0%	0 0%
No value	0 0%	1 1.8%
0 (Absent)	74 58.7%	37 67.3%
1 (Mild)	43 34.1%	15 27.3%
2 (Moderate)	9 7.1%	3 5.5%
3 (Severe)	0 0%	0 0%
No value	0 0%	0 0%
0 (Absent)	109 86.5%	48 87.3%
1 (Mild)	16 12.7%	6 10.9%
2 (Moderate)	0 0%	0 0%
3 (Severe)	0 0%	0 0%
No value	1 0.8%	1 1.8%
0 (Absent)	121 96%	52 94.5%
1 (Mild)	0 0%	0 0%
2 (Moderate)	2 1.6%	0 0%
3 (Severe)	0 0%	0 0%
No value	3 2.4%	3 5.5%
0 (Absent)	123 97.6%	52 94.5%
1 (Mild)	0 0%	0 0%
2 (Moderate)	0 0%	0 0%
3 (Severe)	0 0%	0 0%
No value	3 2.4%	3 5.5%

6. Secondary Outcome

Title	Summary of Concomitant Medications Used in the Study Eye or Both Eyes
Time Frame	Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone Depot	Prednisolone Drops 1% (Standard of Care)
Arm/Group Description	A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery	Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
Measure Participants	126	55
Patients reporting at least one concomitant medica	124 98.4%	55 100%
Antiseptics and disinfectants	1 0.8%	1 1.8%
Anesthetics	4 3.2%	1 1.8%
Psycholeptics	2 1.6%	1 1.8%
Ophthalmologicals	124 98.4%	55 100%
Thyroid therapy	0 0%	1 1.8%

7. Secondary Outcome

Title	Changes in the Corneal Endothelial Cell Count
Description	Corneal Endothelial Cell Density was measured by specular microscopy.
Time Frame	Baseline, Postoperative day 90/Early termination

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone Depot	Prednisolone Drops 1% (Standard of Care)
Arm/Group Description	A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery	Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
Measure Participants	126	55
Baseline	2483.66 (351.819)	2398.33 (384.092)
Postoperative day 90/End of treatment	2141.77 (522.327)	2106.39 (517.938)
Change from Baseline	-334.60 (415.071)	-288.83 (376.775)

8. Secondary Outcome

Title	Optic Disc Cup-disc Ratio for the Study Eye
Description	Calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc).
Time Frame	Baseline, POD 90/Early termination

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone Depot	Prednisolone Drops 1% (Standard of Care)
Arm/Group Description	A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery	Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
Measure Participants	126	55
Screening (Baseline)	.31 (.142)	.32 (.135)
Postoperative day 90/End of treatment	.31 (.131)	.33 (.143)

9. Secondary Outcome

Title	Dilated Opthalmoscopy Findings - Optic Disc (Study Eye)
Description	The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's optic disc
Time Frame	Baseline, POD 90/Early termination

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone Depot	Prednisolone Drops 1% (Standard of Care)
Arm/Group Description	A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery	Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
Measure Participants	126	55
Normal	115 91.3%	52 94.5%
Abnormal	2 1.6%	1 1.8%
Not analyzed	9 7.1%	2 3.6%
Normal	119 94.4%	50 90.9%
Abnormal	2 1.6%	1 1.8%
Not analyzed	5 4%	4 7.3%

10. Secondary Outcome

Title	Dilated Opthalmoscopy Findings - Retina (Study Eye)
Description	The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's retina
Time Frame	Baseline, POD 90/Early termination

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone Depot	Prednisolone Drops 1% (Standard of Care)
Arm/Group Description	A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery	Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
Measure Participants	126	55
Normal	120 95.2%	51 92.7%
Abnormal	5 4%	4 7.3%
Not analyzed	1 0.8%	0 0%
Normal	118 93.7%	50 90.9%
Abnormal	5 4%	1 1.8%
Not analyzed	3 2.4%	4 7.3%

11. Secondary Outcome

Title	Dilated Opthalmoscopy Findings - Macula (Study Eye)
Description	The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's macula.
Time Frame	Baseline, POD 90/Early termination

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone Depot	Prednisolone Drops 1% (Standard of Care)
Arm/Group Description	A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery	Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
Measure Participants	126	55
Normal	109 86.5%	44 80%
Abnormal	15 11.9%	11 20%
Not analyzed	2 1.6%	0 0%
Normal	107 84.9%	39 70.9%
Abnormal	16 12.7%	12 21.8%
Not analyzed	3 2.4%	4 7.3%

12. Secondary Outcome

Title	Dilated Opthalmoscopy Findings - Choroid (Study Eye)
Description	The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's choroid
Time Frame	Baseline, POD 90/Early termination

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone Depot	Prednisolone Drops 1% (Standard of Care)
Arm/Group Description	A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery	Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
Measure Participants	126	55
Normal	124 98.4%	54 98.2%
Abnormal	0 0%	0 0%
Not analyzed	2 1.6%	1 1.8%
Normal	122 96.8%	50 90.9%
Abnormal	1 0.8%	0 0%
Not analyzed	3 2.4%	5 9.1%

13. Secondary Outcome

Title	Dilated Opthalmoscopy Findings - Vitreous (Study Eye)
Description	The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's vitreous
Time Frame	Baseline, POD 90/Early termination

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone Depot	Prednisolone Drops 1% (Standard of Care)
Arm/Group Description	A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery	Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
Measure Participants	126	55
Normal	104 82.5%	49 89.1%
Abnormal	21 16.7%	5 9.1%
Not analyzed	1 0.8%	1 1.8%
Normal	107 84.9%	44 80%
Abnormal	16 12.7%	7 12.7%
Not analyzed	3 2.4%	4 7.3%

Adverse Events

Time Frame	Adverse event data was collected from screening until postoperative day 90/end of treatment.
Arm/Group Title	Dexamethasone Depot		Prednisolone Drops 1% (Standard of Care)
Arm/Group Description	A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery		Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
All Cause Mortality
	Dexamethasone Depot		Prednisolone Drops 1% (Standard of Care)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/126 (0%)		0/55 (0%)
Serious Adverse Events
	Dexamethasone Depot		Prednisolone Drops 1% (Standard of Care)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/126 (2.4%)		0/55 (0%)
Eye disorders
Diabetic retinopathy	1/126 (0.8%)		0/55 (0%)
Gastrointestinal disorders
Abdominal hernia	1/126 (0.8%)		0/55 (0%)
Nervous system disorders
Loss of consciousness	1/126 (0.8%)		0/55 (0%)
Other (Not Including Serious) Adverse Events
	Dexamethasone Depot		Prednisolone Drops 1% (Standard of Care)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	23/126 (18.3%)		6/55 (10.9%)
Eye disorders
Iritis	8/126 (6.3%)		0/55 (0%)
Investigations
Intraocular pressure increased	14/126 (11.1%)		2/55 (3.6%)
Nervous system disorders
Headache	1/126 (0.8%)		4/55 (7.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.