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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02547623

Enrollment

194

Registered

2015-09-11

Start date

2015-11-06

Completion date

2016-08-16

Last updated

2018-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

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.

Detailed description

Interventions

DRUGDexamethasone

depot intracameral

DRUGPrednisolone

Prednisolone eye drops 1%

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

* undergoing cataract surgery

Exclusion criteria

* glaucoma patient, pregnancy, allergy to dexamethasone

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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.
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.
Summary of Concomitant Medications Used in the Study Eye or Both Eyes	Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination	—
Changes in the Corneal Endothelial Cell Count	Baseline, Postoperative day 90/Early termination	Corneal Endothelial Cell Density was measured by specular microscopy.
Intraocular Pressure Measurement	Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination	Intraocular Pressure was measured by Goldmann applanation tonometry.
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
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
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.
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
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
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).

Countries

United States

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 details

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.

Participants by arm

Arm	Count
Dexamethasone Depot A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery	126
Prednisolone Drops 1% (Standard of Care) Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)	55
Total	181

Baseline characteristics

Characteristic	Total	Prednisolone Drops 1% (Standard of Care)	Dexamethasone Depot
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	130 Participants	38 Participants	92 Participants
Age, Categorical Between 18 and 65 years	51 Participants	17 Participants	34 Participants
Best Corrected Visual Acuity fellow eye number	.141 LogMar STANDARD_DEVIATION 0.166	.176 LogMar STANDARD_DEVIATION 0.2123	.126 LogMar STANDARD_DEVIATION 0.1394
Best Corrected Visual Acuity study eye number	.311 LogMar STANDARD_DEVIATION 0.2141	.355 LogMar STANDARD_DEVIATION 0.2557	.292 LogMar STANDARD_DEVIATION 0.1913
Corneal Endothelial Cell Density - Specular Microscopy	2463.15 cells/mm^2 STANDARD_DEVIATION 359.902	2398.33 cells/mm^2 STANDARD_DEVIATION 384.092	2491.91 cells/mm^2 STANDARD_DEVIATION 346.365
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants	1 Participants	9 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	171 Participants	54 Participants	117 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Intraocular Pressure Fellow eye	14.8 mmHg STANDARD_DEVIATION 2.85	14.5 mmHg STANDARD_DEVIATION 2.79	14.9 mmHg STANDARD_DEVIATION 2.88
Intraocular Pressure Study eye	14.9 mmHg STANDARD_DEVIATION 2.88	14.4 mmHg STANDARD_DEVIATION 2.71	15.1 mmHg STANDARD_DEVIATION 2.94
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	3 Participants	2 Participants	1 Participants
Race (NIH/OMB) Black or African American	12 Participants	1 Participants	11 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants	0 Participants	3 Participants
Race (NIH/OMB) White	163 Participants	52 Participants	111 Participants
Region of Enrollment United States	181 Participants	55 Participants	126 Participants
Sex: Female, Male Female	98 Participants	31 Participants	67 Participants
Sex: Female, Male Male	83 Participants	24 Participants	59 Participants
Study Eye OD (Right eye)	94 study eye	27 study eye	67 study eye
Study Eye OS (Left eye)	87 study eye	28 study eye	59 study eye
Use of Femto prior to the Surgery No	148 Participants	47 Participants	101 Participants
Use of Femto prior to the Surgery Yes	33 Participants	8 Participants	25 Participants
Use of Viscoelastic during the Surgery No	0 Participants	0 Participants	0 Participants
Use of Viscoelastic during the Surgery Yes	181 Participants	55 Participants	126 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 126	0 / 55
other Total, other adverse events	23 / 126	6 / 55
serious Total, serious adverse events	3 / 126	0 / 55

Outcome results

Primary

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

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

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Dexamethasone Depot	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Ocular events: study eye	Serious TEAE	1 Participants
Dexamethasone Depot	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Ocular events: fellow eye	No TEAE	114 Participants
Dexamethasone Depot	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Ocular events: fellow eye	Any TEAE	12 Participants
Dexamethasone Depot	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Systemic events	Any TEAE	10 Participants
Dexamethasone Depot	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Ocular events: study eye	No TEAE	72 Participants
Dexamethasone Depot	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Systemic events	Serious TEAE	2 Participants
Dexamethasone Depot	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Ocular events: fellow eye	Serious TEAE	0 Participants
Dexamethasone Depot	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Systemic events	No TEAE	114 Participants
Dexamethasone Depot	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Ocular events: study eye	Any TEAE	53 Participants
Prednisolone Drops 1% (Standard of Care)	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Systemic events	No TEAE	49 Participants
Prednisolone Drops 1% (Standard of Care)	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Ocular events: study eye	Any TEAE	13 Participants
Prednisolone Drops 1% (Standard of Care)	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Ocular events: study eye	Serious TEAE	0 Participants
Prednisolone Drops 1% (Standard of Care)	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Ocular events: study eye	No TEAE	42 Participants
Prednisolone Drops 1% (Standard of Care)	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Ocular events: fellow eye	Any TEAE	4 Participants
Prednisolone Drops 1% (Standard of Care)	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Ocular events: fellow eye	Serious TEAE	0 Participants
Prednisolone Drops 1% (Standard of Care)	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Ocular events: fellow eye	No TEAE	51 Participants
Prednisolone Drops 1% (Standard of Care)	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Systemic events	Any TEAE	6 Participants
Prednisolone Drops 1% (Standard of Care)	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Systemic events	Serious TEAE	0 Participants

Secondary

Changes in the Corneal Endothelial Cell Count

Corneal Endothelial Cell Density was measured by specular microscopy.

Time frame: Baseline, Postoperative day 90/Early termination

Arm	Measure	Group	Value (MEAN)	Dispersion
Dexamethasone Depot	Changes in the Corneal Endothelial Cell Count	Baseline	2483.66 cells/mm^2	Standard Deviation 351.819
Dexamethasone Depot	Changes in the Corneal Endothelial Cell Count	Postoperative day 90/End of treatment	2141.77 cells/mm^2	Standard Deviation 522.327
Dexamethasone Depot	Changes in the Corneal Endothelial Cell Count	Change from Baseline	-334.60 cells/mm^2	Standard Deviation 415.071
Prednisolone Drops 1% (Standard of Care)	Changes in the Corneal Endothelial Cell Count	Baseline	2398.33 cells/mm^2	Standard Deviation 384.092
Prednisolone Drops 1% (Standard of Care)	Changes in the Corneal Endothelial Cell Count	Postoperative day 90/End of treatment	2106.39 cells/mm^2	Standard Deviation 517.938
Prednisolone Drops 1% (Standard of Care)	Changes in the Corneal Endothelial Cell Count	Change from Baseline	-288.83 cells/mm^2	Standard Deviation 376.775

Secondary

Dilated Opthalmoscopy Findings - Choroid (Study Eye)

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

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Dexamethasone Depot	Dilated Opthalmoscopy Findings - Choroid (Study Eye)	Screening (Baseline)	Normal	124 Participants
Dexamethasone Depot	Dilated Opthalmoscopy Findings - Choroid (Study Eye)	Screening (Baseline)	Abnormal	0 Participants
Dexamethasone Depot	Dilated Opthalmoscopy Findings - Choroid (Study Eye)	Screening (Baseline)	Not analyzed	2 Participants
Dexamethasone Depot	Dilated Opthalmoscopy Findings - Choroid (Study Eye)	Postoperative day 90/End of treatment	Normal	122 Participants
Dexamethasone Depot	Dilated Opthalmoscopy Findings - Choroid (Study Eye)	Postoperative day 90/End of treatment	Abnormal	1 Participants
Dexamethasone Depot	Dilated Opthalmoscopy Findings - Choroid (Study Eye)	Postoperative day 90/End of treatment	Not analyzed	3 Participants
Prednisolone Drops 1% (Standard of Care)	Dilated Opthalmoscopy Findings - Choroid (Study Eye)	Postoperative day 90/End of treatment	Abnormal	0 Participants
Prednisolone Drops 1% (Standard of Care)	Dilated Opthalmoscopy Findings - Choroid (Study Eye)	Screening (Baseline)	Normal	54 Participants
Prednisolone Drops 1% (Standard of Care)	Dilated Opthalmoscopy Findings - Choroid (Study Eye)	Postoperative day 90/End of treatment	Normal	50 Participants
Prednisolone Drops 1% (Standard of Care)	Dilated Opthalmoscopy Findings - Choroid (Study Eye)	Screening (Baseline)	Abnormal	0 Participants
Prednisolone Drops 1% (Standard of Care)	Dilated Opthalmoscopy Findings - Choroid (Study Eye)	Postoperative day 90/End of treatment	Not analyzed	5 Participants
Prednisolone Drops 1% (Standard of Care)	Dilated Opthalmoscopy Findings - Choroid (Study Eye)	Screening (Baseline)	Not analyzed	1 Participants

Secondary

Dilated Opthalmoscopy Findings - Macula (Study Eye)

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

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Dexamethasone Depot	Dilated Opthalmoscopy Findings - Macula (Study Eye)	Screening (Baseline)	Normal	109 Participants
Dexamethasone Depot	Dilated Opthalmoscopy Findings - Macula (Study Eye)	Screening (Baseline)	Abnormal	15 Participants
Dexamethasone Depot	Dilated Opthalmoscopy Findings - Macula (Study Eye)	Screening (Baseline)	Not analyzed	2 Participants
Dexamethasone Depot	Dilated Opthalmoscopy Findings - Macula (Study Eye)	Postoperative day 90/End of treatment	Normal	107 Participants
Dexamethasone Depot	Dilated Opthalmoscopy Findings - Macula (Study Eye)	Postoperative day 90/End of treatment	Abnormal	16 Participants
Dexamethasone Depot	Dilated Opthalmoscopy Findings - Macula (Study Eye)	Postoperative day 90/End of treatment	Not analyzed	3 Participants
Prednisolone Drops 1% (Standard of Care)	Dilated Opthalmoscopy Findings - Macula (Study Eye)	Postoperative day 90/End of treatment	Abnormal	12 Participants
Prednisolone Drops 1% (Standard of Care)	Dilated Opthalmoscopy Findings - Macula (Study Eye)	Screening (Baseline)	Normal	44 Participants
Prednisolone Drops 1% (Standard of Care)	Dilated Opthalmoscopy Findings - Macula (Study Eye)	Postoperative day 90/End of treatment	Normal	39 Participants
Prednisolone Drops 1% (Standard of Care)	Dilated Opthalmoscopy Findings - Macula (Study Eye)	Screening (Baseline)	Abnormal	11 Participants
Prednisolone Drops 1% (Standard of Care)	Dilated Opthalmoscopy Findings - Macula (Study Eye)	Postoperative day 90/End of treatment	Not analyzed	4 Participants
Prednisolone Drops 1% (Standard of Care)	Dilated Opthalmoscopy Findings - Macula (Study Eye)	Screening (Baseline)	Not analyzed	0 Participants

Secondary

Dilated Opthalmoscopy Findings - Optic Disc (Study Eye)

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

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Dexamethasone Depot	Dilated Opthalmoscopy Findings - Optic Disc (Study Eye)	Screening (Baseline)	Normal	115 Participants
Dexamethasone Depot	Dilated Opthalmoscopy Findings - Optic Disc (Study Eye)	Screening (Baseline)	Abnormal	2 Participants
Dexamethasone Depot	Dilated Opthalmoscopy Findings - Optic Disc (Study Eye)	Screening (Baseline)	Not analyzed	9 Participants
Dexamethasone Depot	Dilated Opthalmoscopy Findings - Optic Disc (Study Eye)	Postoperative day 90/End of treatment	Normal	119 Participants
Dexamethasone Depot	Dilated Opthalmoscopy Findings - Optic Disc (Study Eye)	Postoperative day 90/End of treatment	Abnormal	2 Participants
Dexamethasone Depot	Dilated Opthalmoscopy Findings - Optic Disc (Study Eye)	Postoperative day 90/End of treatment	Not analyzed	5 Participants
Prednisolone Drops 1% (Standard of Care)	Dilated Opthalmoscopy Findings - Optic Disc (Study Eye)	Postoperative day 90/End of treatment	Abnormal	1 Participants
Prednisolone Drops 1% (Standard of Care)	Dilated Opthalmoscopy Findings - Optic Disc (Study Eye)	Screening (Baseline)	Normal	52 Participants
Prednisolone Drops 1% (Standard of Care)	Dilated Opthalmoscopy Findings - Optic Disc (Study Eye)	Postoperative day 90/End of treatment	Normal	50 Participants
Prednisolone Drops 1% (Standard of Care)	Dilated Opthalmoscopy Findings - Optic Disc (Study Eye)	Screening (Baseline)	Abnormal	1 Participants
Prednisolone Drops 1% (Standard of Care)	Dilated Opthalmoscopy Findings - Optic Disc (Study Eye)	Postoperative day 90/End of treatment	Not analyzed	4 Participants
Prednisolone Drops 1% (Standard of Care)	Dilated Opthalmoscopy Findings - Optic Disc (Study Eye)	Screening (Baseline)	Not analyzed	2 Participants

Secondary

Dilated Opthalmoscopy Findings - Retina (Study Eye)

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

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Dexamethasone Depot	Dilated Opthalmoscopy Findings - Retina (Study Eye)	Screening (Baseline)	Normal	120 Participants
Dexamethasone Depot	Dilated Opthalmoscopy Findings - Retina (Study Eye)	Screening (Baseline)	Abnormal	5 Participants
Dexamethasone Depot	Dilated Opthalmoscopy Findings - Retina (Study Eye)	Screening (Baseline)	Not analyzed	1 Participants
Dexamethasone Depot	Dilated Opthalmoscopy Findings - Retina (Study Eye)	Postoperative day 90/End of treatment	Normal	118 Participants
Dexamethasone Depot	Dilated Opthalmoscopy Findings - Retina (Study Eye)	Postoperative day 90/End of treatment	Abnormal	5 Participants
Dexamethasone Depot	Dilated Opthalmoscopy Findings - Retina (Study Eye)	Postoperative day 90/End of treatment	Not analyzed	3 Participants
Prednisolone Drops 1% (Standard of Care)	Dilated Opthalmoscopy Findings - Retina (Study Eye)	Postoperative day 90/End of treatment	Abnormal	1 Participants
Prednisolone Drops 1% (Standard of Care)	Dilated Opthalmoscopy Findings - Retina (Study Eye)	Screening (Baseline)	Normal	51 Participants
Prednisolone Drops 1% (Standard of Care)	Dilated Opthalmoscopy Findings - Retina (Study Eye)	Postoperative day 90/End of treatment	Normal	50 Participants
Prednisolone Drops 1% (Standard of Care)	Dilated Opthalmoscopy Findings - Retina (Study Eye)	Screening (Baseline)	Abnormal	4 Participants
Prednisolone Drops 1% (Standard of Care)	Dilated Opthalmoscopy Findings - Retina (Study Eye)	Postoperative day 90/End of treatment	Not analyzed	4 Participants
Prednisolone Drops 1% (Standard of Care)	Dilated Opthalmoscopy Findings - Retina (Study Eye)	Screening (Baseline)	Not analyzed	0 Participants

Secondary

Dilated Opthalmoscopy Findings - Vitreous (Study Eye)

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

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Dexamethasone Depot	Dilated Opthalmoscopy Findings - Vitreous (Study Eye)	Screening (Baseline)	Not analyzed	1 Participants
Dexamethasone Depot	Dilated Opthalmoscopy Findings - Vitreous (Study Eye)	Postoperative day 90/End of treatment	Abnormal	16 Participants
Dexamethasone Depot	Dilated Opthalmoscopy Findings - Vitreous (Study Eye)	Screening (Baseline)	Abnormal	21 Participants
Dexamethasone Depot	Dilated Opthalmoscopy Findings - Vitreous (Study Eye)	Postoperative day 90/End of treatment	Not analyzed	3 Participants
Dexamethasone Depot	Dilated Opthalmoscopy Findings - Vitreous (Study Eye)	Postoperative day 90/End of treatment	Normal	107 Participants
Dexamethasone Depot	Dilated Opthalmoscopy Findings - Vitreous (Study Eye)	Screening (Baseline)	Normal	104 Participants
Prednisolone Drops 1% (Standard of Care)	Dilated Opthalmoscopy Findings - Vitreous (Study Eye)	Postoperative day 90/End of treatment	Normal	44 Participants
Prednisolone Drops 1% (Standard of Care)	Dilated Opthalmoscopy Findings - Vitreous (Study Eye)	Screening (Baseline)	Abnormal	5 Participants
Prednisolone Drops 1% (Standard of Care)	Dilated Opthalmoscopy Findings - Vitreous (Study Eye)	Screening (Baseline)	Not analyzed	1 Participants
Prednisolone Drops 1% (Standard of Care)	Dilated Opthalmoscopy Findings - Vitreous (Study Eye)	Screening (Baseline)	Normal	49 Participants
Prednisolone Drops 1% (Standard of Care)	Dilated Opthalmoscopy Findings - Vitreous (Study Eye)	Postoperative day 90/End of treatment	Abnormal	7 Participants
Prednisolone Drops 1% (Standard of Care)	Dilated Opthalmoscopy Findings - Vitreous (Study Eye)	Postoperative day 90/End of treatment	Not analyzed	4 Participants

Secondary

Intraocular Pressure Measurement

Intraocular Pressure was measured by Goldmann applanation tonometry.

Time frame: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination

Arm	Measure	Group	Value (MEAN)	Dispersion
Dexamethasone Depot	Intraocular Pressure Measurement	Post Operative Day 1	19.1 mmHG	Standard Deviation 6.54
Dexamethasone Depot	Intraocular Pressure Measurement	Post Operative Day 30	13.8 mmHG	Standard Deviation 3.2
Dexamethasone Depot	Intraocular Pressure Measurement	Post Operative Day 8	15.0 mmHG	Standard Deviation 4.7
Dexamethasone Depot	Intraocular Pressure Measurement	Post Operative Day 90/End of Treatment	13.0 mmHG	Standard Deviation 2.89
Dexamethasone Depot	Intraocular Pressure Measurement	Screening (Baseline)	15.1 mmHG	Standard Deviation 2.94
Prednisolone Drops 1% (Standard of Care)	Intraocular Pressure Measurement	Post Operative Day 90/End of Treatment	12.7 mmHG	Standard Deviation 2.93
Prednisolone Drops 1% (Standard of Care)	Intraocular Pressure Measurement	Screening (Baseline)	14.4 mmHG	Standard Deviation 2.71
Prednisolone Drops 1% (Standard of Care)	Intraocular Pressure Measurement	Post Operative Day 1	17.5 mmHG	Standard Deviation 6.44
Prednisolone Drops 1% (Standard of Care)	Intraocular Pressure Measurement	Post Operative Day 8	15.1 mmHG	Standard Deviation 3.64
Prednisolone Drops 1% (Standard of Care)	Intraocular Pressure Measurement	Post Operative Day 30	14.1 mmHG	Standard Deviation 3.57

Secondary

Optic Disc Cup-disc Ratio for the Study Eye

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Dexamethasone Depot	Optic Disc Cup-disc Ratio for the Study Eye	Screening (Baseline)	.31 ratio	Standard Deviation 0.142
Dexamethasone Depot	Optic Disc Cup-disc Ratio for the Study Eye	Postoperative day 90/End of treatment	.31 ratio	Standard Deviation 0.131
Prednisolone Drops 1% (Standard of Care)	Optic Disc Cup-disc Ratio for the Study Eye	Screening (Baseline)	.32 ratio	Standard Deviation 0.135
Prednisolone Drops 1% (Standard of Care)	Optic Disc Cup-disc Ratio for the Study Eye	Postoperative day 90/End of treatment	.33 ratio	Standard Deviation 0.143

Secondary

Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade

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

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Dexamethasone Depot	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Baseline	2 (Moderate)	1 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 8	3 (Severe)	0 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 1	2 (Moderate)	2 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 8	No value	0 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Baseline	No value	0 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 30	0 (Absent)	107 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 1	3 (Severe)	0 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 30	1 (Mild)	14 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Baseline	1 (Mild)	1 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 30	2 (Moderate)	2 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 1	No value	0 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 30	3 (Severe)	0 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 1	0 (Absent)	103 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 30	No value	3 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 8	0 (Absent)	115 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 90/End of Treatment	0 (Absent)	119 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Baseline	3 (Severe)	0 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 90/End of Treatment	1 (Mild)	4 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 8	1 (Mild)	11 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 90/End of Treatment	2 (Moderate)	0 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 1	1 (Mild)	21 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 90/End of Treatment	3 (Severe)	0 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 8	2 (Moderate)	0 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 90/End of Treatment	No value	3 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Baseline	0 (Absent)	124 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 90/End of Treatment	No value	3 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Baseline	0 (Absent)	55 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Baseline	1 (Mild)	0 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Baseline	2 (Moderate)	0 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Baseline	3 (Severe)	0 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Baseline	No value	0 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 1	0 (Absent)	45 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 1	1 (Mild)	10 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 1	2 (Moderate)	0 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 1	3 (Severe)	0 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 1	No value	0 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 8	0 (Absent)	45 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 8	1 (Mild)	8 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 8	2 (Moderate)	0 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 8	3 (Severe)	0 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 8	No value	2 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 30	0 (Absent)	44 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 30	1 (Mild)	8 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 30	2 (Moderate)	0 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 30	3 (Severe)	0 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 30	No value	3 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 90/End of Treatment	0 (Absent)	50 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 90/End of Treatment	1 (Mild)	2 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 90/End of Treatment	2 (Moderate)	0 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade	Postoperative day 90/End of Treatment	3 (Severe)	0 Participants

Secondary

Slit Lamp Biomicroscopy - Cornea Edema Grade

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

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Dexamethasone Depot	Slit Lamp Biomicroscopy - Cornea Edema Grade	Baseline	2 (Moderate)	0 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 8	3 (Severe)	0 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 1	2 (Moderate)	9 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 8	No value	1 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Cornea Edema Grade	Baseline	No value	0 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 30	0 (Absent)	121 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 1	3 (Severe)	0 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 30	1 (Mild)	0 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Cornea Edema Grade	Baseline	0 (Absent)	126 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 30	2 (Moderate)	2 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 1	No value	0 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 30	3 (Severe)	0 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 1	0 (Absent)	74 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 30	No value	3 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 8	0 (Absent)	109 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 90/End of Treatment	0 (Absent)	123 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Cornea Edema Grade	Baseline	3 (Severe)	0 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 90/End of Treatment	1 (Mild)	0 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 8	1 (Mild)	16 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 90/End of Treatment	2 (Moderate)	0 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 1	1 (Mild)	43 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 90/End of Treatment	3 (Severe)	0 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 8	2 (Moderate)	0 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 90/End of Treatment	No value	3 Participants
Dexamethasone Depot	Slit Lamp Biomicroscopy - Cornea Edema Grade	Baseline	1 (Mild)	0 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 90/End of Treatment	No value	3 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Cornea Edema Grade	Baseline	0 (Absent)	54 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Cornea Edema Grade	Baseline	1 (Mild)	0 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Cornea Edema Grade	Baseline	2 (Moderate)	0 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Cornea Edema Grade	Baseline	3 (Severe)	0 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Cornea Edema Grade	Baseline	No value	1 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 1	0 (Absent)	37 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 1	1 (Mild)	15 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 1	2 (Moderate)	3 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 1	3 (Severe)	0 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 1	No value	0 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 8	0 (Absent)	48 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 8	1 (Mild)	6 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 8	2 (Moderate)	0 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 8	3 (Severe)	0 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 8	No value	1 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 30	0 (Absent)	52 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 30	1 (Mild)	0 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 30	2 (Moderate)	0 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 30	3 (Severe)	0 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 30	No value	3 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 90/End of Treatment	0 (Absent)	52 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 90/End of Treatment	1 (Mild)	0 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 90/End of Treatment	2 (Moderate)	0 Participants
Prednisolone Drops 1% (Standard of Care)	Slit Lamp Biomicroscopy - Cornea Edema Grade	Postoperative day 90/End of Treatment	3 (Severe)	0 Participants

Secondary

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Dexamethasone Depot	Summary of Concomitant Medications Used in the Study Eye or Both Eyes	Patients reporting at least one concomitant medica	124 Participants
Dexamethasone Depot	Summary of Concomitant Medications Used in the Study Eye or Both Eyes	Antiseptics and disinfectants	1 Participants
Dexamethasone Depot	Summary of Concomitant Medications Used in the Study Eye or Both Eyes	Anesthetics	4 Participants
Dexamethasone Depot	Summary of Concomitant Medications Used in the Study Eye or Both Eyes	Psycholeptics	2 Participants
Dexamethasone Depot	Summary of Concomitant Medications Used in the Study Eye or Both Eyes	Ophthalmologicals	124 Participants
Dexamethasone Depot	Summary of Concomitant Medications Used in the Study Eye or Both Eyes	Thyroid therapy	0 Participants
Prednisolone Drops 1% (Standard of Care)	Summary of Concomitant Medications Used in the Study Eye or Both Eyes	Ophthalmologicals	55 Participants
Prednisolone Drops 1% (Standard of Care)	Summary of Concomitant Medications Used in the Study Eye or Both Eyes	Patients reporting at least one concomitant medica	55 Participants
Prednisolone Drops 1% (Standard of Care)	Summary of Concomitant Medications Used in the Study Eye or Both Eyes	Psycholeptics	1 Participants
Prednisolone Drops 1% (Standard of Care)	Summary of Concomitant Medications Used in the Study Eye or Both Eyes	Antiseptics and disinfectants	1 Participants
Prednisolone Drops 1% (Standard of Care)	Summary of Concomitant Medications Used in the Study Eye or Both Eyes	Thyroid therapy	1 Participants
Prednisolone Drops 1% (Standard of Care)	Summary of Concomitant Medications Used in the Study Eye or Both Eyes	Anesthetics	1 Participants

Secondary

Visual Acuity in Study Eye

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Dexamethasone Depot	Visual Acuity in Study Eye	Post Operative Day 1	.249 LogMar	Standard Deviation 0.1398
Dexamethasone Depot	Visual Acuity in Study Eye	Post Operative Day 30	.039 LogMar	Standard Deviation 0.0952
Dexamethasone Depot	Visual Acuity in Study Eye	Post Operative Day 8	.073 LogMar	Standard Deviation 0.1353
Dexamethasone Depot	Visual Acuity in Study Eye	Post Operative Day 90/End of Treatment	.040 LogMar	Standard Deviation 0.1012
Dexamethasone Depot	Visual Acuity in Study Eye	Screening (Baseline)	.292 LogMar	Standard Deviation 0.1913
Prednisolone Drops 1% (Standard of Care)	Visual Acuity in Study Eye	Post Operative Day 90/End of Treatment	.047 LogMar	Standard Deviation 0.115
Prednisolone Drops 1% (Standard of Care)	Visual Acuity in Study Eye	Screening (Baseline)	.355 LogMar	Standard Deviation 0.2557
Prednisolone Drops 1% (Standard of Care)	Visual Acuity in Study Eye	Post Operative Day 1	.327 LogMar	Standard Deviation 0.2129
Prednisolone Drops 1% (Standard of Care)	Visual Acuity in Study Eye	Post Operative Day 8	.073 LogMar	Standard Deviation 0.1746
Prednisolone Drops 1% (Standard of Care)	Visual Acuity in Study Eye	Post Operative Day 30	.040 LogMar	Standard Deviation 0.135

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

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

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Changes in the Corneal Endothelial Cell Count

Dilated Opthalmoscopy Findings - Choroid (Study Eye)

Dilated Opthalmoscopy Findings - Macula (Study Eye)

Dilated Opthalmoscopy Findings - Optic Disc (Study Eye)

Dilated Opthalmoscopy Findings - Retina (Study Eye)

Dilated Opthalmoscopy Findings - Vitreous (Study Eye)

Intraocular Pressure Measurement

Optic Disc Cup-disc Ratio for the Study Eye

Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade

Slit Lamp Biomicroscopy - Cornea Edema Grade

Summary of Concomitant Medications Used in the Study Eye or Both Eyes

Visual Acuity in Study Eye