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The purpose of this study is to evaluate the ocular safety, tolerability and efficacy of topical administration of ISV-303 compared with Durasite Vehicle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ISV-303 | Experimental |
| |
| Durasite Vehicle | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ISV-303 | Drug | 0.075% bromfenac in DuraSite dosed BID |
| |
| DuraSite Vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Inflammation | Anterior chamber cell grade 0 at Day 15 measured on a 0 to 4 scale where "0" is 0 cells; "1" is 1-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is > 50 cells, and no rescue medications. | 15 days |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | ISV-303 | 0.075% bromfenac in DuraSite dosed BID |
| FG001 | Vehicle | DuraSite vehicle dosed BID |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Modified Intent-to-Treat: subjects who were randomized into the trial, underwent cataract surgery, and received at least one dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | ISV-303 | 0.075% bromfenac in DuraSite dosed BID |
| BG001 | Vehicle | DuraSite vehicle dosed BID |
| 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 | Ocular Inflammation | Anterior chamber cell grade 0 at Day 15 measured on a 0 to 4 scale where "0" is 0 cells; "1" is 1-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is > 50 cells, and no rescue medications. | Modified Intent-to-Treat (ITT) Population using Last Observation Carried Forward (LOCF) method. | Posted | Number | participants | 15 days |
|
29 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 dosed BID |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular hypertension | Eye disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Manager, Clinical Sciences | InSite Vision | manjiri.desai@sparcmail.com |
| ID | Term |
|---|---|
| C053083 | bromfenac |
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| Other |
DuraSite vehicle dosed BID |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 1 |
| 170 |
| 17 |
| 170 |
| EG001 | Vehicle | DuraSite vehicle dosed BID | 1 | 85 | 5 | 85 |
| Chest pain | General disorders | MedDRA 15.0 | Non-systematic Assessment |
|
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