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This is a safety and efficacy study of bromfenac ophthalmic solution
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bromfenac Ophthalmic Solution 0.18% | Experimental |
| |
| Xibrom 0.09% | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bromfenac ophthalmic solution | Drug | sterile opthalmic solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero | Participants with SOIS of 1. Scale: 0=0 cells (complete absence); 0.5=1-5 cells (trace); 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=>50 cells (intense) | Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Are Pain Free | Participant description of being pain free taken from patient questionnaire with multiple possible responses | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tim McNamara, PharmD | ISTA Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ISTA Pharmaceuticals, Inc. | Irvine | California | 92618 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bromfenac Ophthalmic Solution 0.18% | |
| FG001 | Xibrom 0.09% |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bromfenac Ophthalmic Solution 0.18% | |
| BG001 | Xibrom 0.09% | |
| BG002 | Total |
| 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 | Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero | Participants with SOIS of 1. Scale: 0=0 cells (complete absence); 0.5=1-5 cells (trace); 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=>50 cells (intense) | Posted | Number | Participant | Day 15 |
|
|
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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 | Bromfenac Ophthalmic Solution 0.18% |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Necrosis | Skin and subcutaneous tissue disorders | MedDRA 6.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival Hyperaemia | Eye disorders | MedDRA 6.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tim McNamara, PharmD | ISTA Pharmaceuticals, Inc. | 949-788-6000 | tmcnamara@istavision.com |
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| Enrollment met/over-enrolled |
|
Total of all reporting groups
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
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| Secondary | Number of Participants That Are Pain Free | Participant description of being pain free taken from patient questionnaire with multiple possible responses | Posted | Number | Participant | Day 1 |
|
|
|
| 2 |
| 266 |
| 13 |
| 266 |
| EG001 | Xibrom 0.09% | 3 | 278 | 19 | 278 |
| Abnormal Skin Odor | Skin and subcutaneous tissue disorders | MedDRA 6.1 | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA 6.1 | Systematic Assessment |
|
| Anterior Chamber Inflammation | Eye disorders | MedDRA 6.1 | Systematic Assessment |
|
| Upper Abdominal Pain | Gastrointestinal disorders | MedDRA 6.1 | Systematic Assessment |
|
| Kidney Infection | Renal and urinary disorders | MedDRA 6.1 | Systematic Assessment |
|
The PI will provide to the sponsor a copy of the proposed publication information for review, comment and approval following completion of the study and at least sixty (60) days prior to submission for publication of any manuscript, or at least thirty (30) days prior to submission for publication of any abstract. If sponsor requests in writing, the PI will withhold publication for an additional sixty (60) days.