| Primary | Change From Baseline in Central Corneal Endothelial Cell Counts | Count of central corneal endothelial cells 12 weeks post cataract surgery, compared to baseline | Intent-to-treat population (all randomized patients) | Posted | | Mean | Standard Deviation | cells/mm^2 | | 12 weeks | | | | ID | Title | Description |
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| OG000 | Vehicle Ophthalmic Solution | A single drop of Vehicle Ophthalmic solution was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery Vehicle Ophthalmic Solution: Opthalmic suspension manufactured to mimic RTA 408 suspension | | OG001 | Omaveloxolone Opthalmic Suspension 0.5% | A single drop of Omaveloxolone Ophthalmic suspension 0.5% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery Omaveloxolone Ophthalmic Suspension 0.5%: 0.5% ophthalmic suspension of RTA 408 | | OG002 | Omaveloxolone Opthalmic Suspension 1% | A single drop of Omaveloxolone Ophthalmic suspension 1.0% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery Omaveloxolone Ophthalmic Suspension 1%: 1% ophthalmic suspension of RTA 408 |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-243.4± 340.58
- OG001-184.8± 237.00
- OG002-260.3± 304.58
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Comparison of Omaveloxolone Ophthalmic Suspension pooled (0.5% and 1.0%) versus Vehicle Ophthalmic Solution | ANCOVA | Missing data were imputed. | 0.4529 | | LS Mean difference (Net) | 26.95 | | | 2-Sided | | | | | | Difference is Omaveloxolone Ophthalmic Suspension (pooled) - Vehicle Ophthalmic Solution | | Superiority | | | |
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| Secondary | Percentage of Patients With Absence of Anterior Chamber Cells at 2 Weeks After Cataract Surgery | Absence of of anterior chamber cells is defined as anterior chamber cells = 0 | Modified intent-to-treat population (all randomized patients with no imputation for missing data) | Posted | | Count of Participants | | Participants | | 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Vehicle Ophthalmic Solution | A single drop of Vehicle Ophthalmic solution was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery Vehicle Ophthalmic Solution: Opthalmic suspension manufactured to mimic RTA 408 suspension | | OG001 | Omaveloxolone Opthalmic Suspension 0.5% | A single drop of Omaveloxolone Ophthalmic suspension 0.5% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery Omaveloxolone Ophthalmic Suspension 0.5%: 0.5% ophthalmic suspension of RTA 408 | | OG002 | Omaveloxolone Opthalmic Suspension 1% | A single drop of Omaveloxolone Ophthalmic suspension 1.0% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery Omaveloxolone Ophthalmic Suspension 1%: 1% ophthalmic suspension of RTA 408 |
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| Secondary | Percentage of Patients With Absence of Anterior Chamber Flare at 2 Weeks After Cataract Surgery | Absence of of anterior chamber flare is defined as anterior chamber flare = 0 | Modified intent-to-treat population (all randomized patients with no imputation for missing data) | Posted | | Count of Participants | | Participants | | 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Vehicle Ophthalmic Solution | A single drop of Vehicle Ophthalmic solution was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery Vehicle Ophthalmic Solution: Opthalmic suspension manufactured to mimic RTA 408 suspension | | OG001 | Omaveloxolone Opthalmic Suspension 0.5% | A single drop of Omaveloxolone Ophthalmic suspension 0.5% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery Omaveloxolone Ophthalmic Suspension 0.5%: 0.5% ophthalmic suspension of RTA 408 | | OG002 | Omaveloxolone Opthalmic Suspension 1% | A single drop of Omaveloxolone Ophthalmic suspension 1.0% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery Omaveloxolone Ophthalmic Suspension 1%: 1% ophthalmic suspension of RTA 408 |
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| Secondary | Percentage of Patients With Clinical Cure (Absence of Anterior Chamber Cells + Flare) at 2 Weeks After Cataract Surgery | Absence of of anterior chamber cells + flare is defined as anterior chamber cells + flare = 0 | Modified intent-to-treat population (all randomized patients with no imputation for missing data) | Posted | | Count of Participants | | Participants | | 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Vehicle Ophthalmic Solution | A single drop of Vehicle Ophthalmic solution was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery Vehicle Ophthalmic Solution: Opthalmic suspension manufactured to mimic RTA 408 suspension | | OG001 | Omaveloxolone Opthalmic Suspension 0.5% | A single drop of Omaveloxolone Ophthalmic suspension 0.5% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery Omaveloxolone Ophthalmic Suspension 0.5%: 0.5% ophthalmic suspension of RTA 408 | | OG002 | Omaveloxolone Opthalmic Suspension 1% | |
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| Secondary | Percentage of Patients Who Were Pain Free 1 Day After Cataract Surgery | | Modified intent-to-treat population (all randomized patients with no imputation for missing data) | Posted | | Count of Participants | | Participants | | 1 day | | | | ID | Title | Description |
|---|
| OG000 | Vehicle Ophthalmic Solution | A single drop of Vehicle Ophthalmic solution was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery Vehicle Ophthalmic Solution: Opthalmic suspension manufactured to mimic RTA 408 suspension | | OG001 | Omaveloxolone Opthalmic Suspension 0.5% | A single drop of Omaveloxolone Ophthalmic suspension 0.5% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery Omaveloxolone Ophthalmic Suspension 0.5%: 0.5% ophthalmic suspension of RTA 408 | | OG002 | Omaveloxolone Opthalmic Suspension 1% | A single drop of Omaveloxolone Ophthalmic suspension 1.0% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery Omaveloxolone Ophthalmic Suspension 1%: 1% ophthalmic suspension of RTA 408 |
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| Secondary | Change From Baseline in Central Corneal Endothelial Cell Counts | Count of central corneal endothelial cells 6 weeks post cataract surgery, compared to baseline | Intent-to-treat population (all randomized patients) | Posted | | Mean | Standard Deviation | cells/mm^2 | | 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Vehicle Ophthalmic Solution | A single drop of Vehicle Ophthalmic solution was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery Vehicle Ophthalmic Solution: Opthalmic suspension manufactured to mimic RTA 408 suspension | | OG001 | Omaveloxolone Opthalmic Suspension 0.5% | A single drop of Omaveloxolone Ophthalmic suspension 0.5% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery Omaveloxolone Ophthalmic Suspension 0.5%: 0.5% ophthalmic suspension of RTA 408 | | OG002 | Omaveloxolone Opthalmic Suspension 1% | A single drop of Omaveloxolone Ophthalmic suspension 1.0% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery Omaveloxolone Ophthalmic Suspension 1%: 1% ophthalmic suspension of RTA 408 |
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