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The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy in topical administration of differing dosing regimens of ISV-303 compared to vehicle and Xibrom™ when dosed for 2 weeks in post-cataract-surgery volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ISV-303 BID | Experimental |
| |
| ISV-303 QD | Experimental |
| |
| Xibrom BID | Active Comparator |
| |
| DuraSite Vehicle BID | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ISV-303 | Drug | 0.075% of bromfenac in DuraSite dosed QD |
| |
| ISV-303 |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Inflammation | Anterior Chamber Cell Grade 0 at Day 15 measured on a 0 to 4 scale: "0" is 0 cells; "1" is 1-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is > 50 cells. | 15 days |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28819932 | Derived | Trattler W, Hosseini K. Twice-Daily vs. Once-Daily Dosing with 0.075% Bromfenac in DuraSite: Outcomes from a 14-Day Phase 2 Study. Ophthalmol Ther. 2017 Dec;6(2):277-284. doi: 10.1007/s40123-017-0102-x. Epub 2017 Aug 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ISV-303 BID | ISV-303: 0.075% bromfenac in DuraSite dosed BID |
| FG001 | ISV-303 QD | ISV-303: 0.075% bromfenac in DuraSite dosed QD |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
0.075% of bromfenac in DuraSite dosed BID |
|
| DuraSite Vehicle | Drug | Vehicle dosed BID |
|
| Xibrom™ | Drug | 0.09% bromfenac dosed BID |
|
| FG002 | Xibrom BID | Xibrom™: 0.09% bromfenac dosed BID |
| FG003 | DuraSite Vehicle BID | DuraSite Vehicle: Vehicle dosed BID |
| COMPLETED |
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| NOT COMPLETED |
|
All randomized subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | ISV-303 BID | ISV-303: 0.075% of Bromfenac in DuraSite Dosed BID |
| BG001 | ISV-303 QD | ISV-303: 0.075% of Bromfenac in DuraSite Dosed QD |
| BG002 | Xibrom BID | Xibrom™: Xibrom dosed BID |
| BG003 | DuraSite Vehicle BID | DuraSite Vehicle: Vehicle Dosed BID |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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: "0" is 0 cells; "1" is 1-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is > 50 cells. | 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 BID | ISV-303: 0.075% of Bromfenac in DuraSite Dosed BID | 1 | 40 | 0 | 40 | ||
| EG001 | ISV-303 QD | ISV-303: 0.075% of Bromfenac in DuraSite Dosed QD | 0 | 45 | 4 | 45 | ||
| EG002 | Xibrom BID | Xibrom™: Xibrom dosed BID | 1 | 42 | 1 | 42 | ||
| EG003 | DuraSite Vehicle BID | DuraSite Vehicle: Vehicle Dosed BID | 0 | 42 | 1 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Faecaloma | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iritis | Eye disorders | MedDRA 13.1 | 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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| 31-50 years |
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| 51-70 years |
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| >70 years |
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| Male |
|