| 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. | | Posted | | Count of Participants | | Participants | | Baseline to postoperative day 90/ early termination | | | | ID | Title | Description |
|---|
| OG000 | Dexamethasone Depot | A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery | | OG001 | Prednisolone Drops 1% (Standard of Care) | Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks) |
| | | Title | Denominators | Categories |
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| Ocular events: study eye | | | Title | Measurements |
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| Any TEAE | | | Serious TEAE | |
|
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| Secondary | Intraocular Pressure Measurement | Intraocular Pressure was measured by Goldmann applanation tonometry. | | Posted | | Mean | Standard Deviation | mmHG | | Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination | | | | ID | Title | Description |
|---|
| OG000 | Dexamethasone Depot | A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery | | OG001 | Prednisolone Drops 1% (Standard of Care) | Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks) |
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| 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 | | Posted | | Mean | Standard Deviation | LogMar | | Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination | | | | ID | Title | Description |
|---|
| OG000 | Dexamethasone Depot | A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery | | OG001 | Prednisolone Drops 1% (Standard of Care) | Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks) |
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| 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. | | Posted | | Count of Participants | | Participants | | Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination | | | | ID | Title | Description |
|---|
| OG000 | Dexamethasone Depot | A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery | | OG001 | Prednisolone Drops 1% (Standard of Care) | Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks) |
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| 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. | | Posted | | Count of Participants | | Participants | | Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination | | | | ID | Title | Description |
|---|
| OG000 | Dexamethasone Depot | A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery | | OG001 | Prednisolone Drops 1% (Standard of Care) | Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks) |
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| Secondary | Summary of Concomitant Medications Used in the Study Eye or Both Eyes | | | Posted | | Count of Participants | | Participants | | Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination | | | | ID | Title | Description |
|---|
| OG000 | Dexamethasone Depot | A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery | | OG001 | Prednisolone Drops 1% (Standard of Care) | Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks) |
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| Secondary | Changes in the Corneal Endothelial Cell Count | Corneal Endothelial Cell Density was measured by specular microscopy. | | Posted | | Mean | Standard Deviation | cells/mm^2 | | Baseline, Postoperative day 90/Early termination | | | | ID | Title | Description |
|---|
| OG000 | Dexamethasone Depot | A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery | | OG001 | Prednisolone Drops 1% (Standard of Care) | Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks) |
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| 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). | | Posted | | Mean | Standard Deviation | ratio | | Baseline, POD 90/Early termination | | | | ID | Title | Description |
|---|
| OG000 | Dexamethasone Depot | A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery | | OG001 | Prednisolone Drops 1% (Standard of Care) | Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks) |
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| 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 | | Posted | | Count of Participants | | Participants | | Baseline, POD 90/Early termination | | | | ID | Title | Description |
|---|
| OG000 | Dexamethasone Depot | A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery | | OG001 | Prednisolone Drops 1% (Standard of Care) | Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks) |
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| 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 | | Posted | | Count of Participants | | Participants | | Baseline, POD 90/Early termination | | | | ID | Title | Description |
|---|
| OG000 | Dexamethasone Depot | A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery | | OG001 | Prednisolone Drops 1% (Standard of Care) | Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks) |
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| 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. | | Posted | | Count of Participants | | Participants | | Baseline, POD 90/Early termination | | | | ID | Title | Description |
|---|
| OG000 | Dexamethasone Depot | A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery | | OG001 | Prednisolone Drops 1% (Standard of Care) | Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks) |
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| 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 | | Posted | | Count of Participants | | Participants | | Baseline, POD 90/Early termination | | | | ID | Title | Description |
|---|
| OG000 | Dexamethasone Depot | A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery | | OG001 | Prednisolone Drops 1% (Standard of Care) | Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks) |
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| 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 | | Posted | | Count of Participants | | Participants | | Baseline, POD 90/Early termination | | | | ID | Title | Description |
|---|
| OG000 | Dexamethasone Depot | A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery | | OG001 | Prednisolone Drops 1% (Standard of Care) | Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks) |
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