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The purpose of this study is to evaluate the aqueous humor concentration of bromfenac sodium in subjects administered multiple topical ocular doses of ISV-303 or Bromday™ QD prior to routine cataract surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ISV-303 | Experimental |
| |
| Bromday™ | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ISV-303 | Drug | 0.075% bromfenac in DuraSite dosed QD |
| |
| Bromday™ |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Aqueous Humor Bromfenac Concentration | Approximately 3 hours post last dose |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | ISV-303 | 0.075% bromfenac in DuraSite vehicle dosed QD |
| FG001 | Bromday | 0.09% bromfenac dosed QD |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Intent-to-treat Population
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| ID | Title | Description |
|---|---|---|
| BG000 | ISV-303 | 0.075% bromfenac in DuraSite vehicle dosed QD |
| BG001 | Bromday | 0.09% bromfenac dosed QD |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Aqueous Humor Bromfenac Concentration | Per-Protocol Population | Posted | Mean | Standard Deviation | ng/mL | Approximately 3 hours post last dose |
|
|
4 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ISV-303 | 0.075% bromfenac in DuraSite vehicle dosed QD |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Manager, Clinical Sciences | InSite Vision | manjiri.desai@sparcmail.com |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C053083 | bromfenac |
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| Drug |
0.09% bromfenac dosed QD |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Bromday | 0.09% bromfenac dosed QD | 0 | 29 | 0 | 29 |
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