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A dose ranging study to evaluate safety and efficacy of bromfenac ophthalmic solution in dry eye disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bromfenac Ophthalmic Solution A | Experimental | Bromfenac ophthalmic solution A |
|
| Bromfenac Ophthalmic Solution B | Experimental | Bromfenac ophthalmic solution B |
|
| Placebo Comparator | Placebo Comparator | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bromfenac Ophthalmic Solution A | Drug | sterile ophthalmic solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Ocular Surface Disease Index (OSDI) Total Score | The Ocular Surface Disease Index (OSDI) is a 12 item questionnaire. Each question about discomfort/limitations is scored from 0 to 4, with 0 being 'None of the Time' and 4 being 'All of the Time'. The minimum total score is 0 and the maximum total score is 48, with higher scores indicating worse outcomes. | 42 days |
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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 0.06% | Bromfenac Ophthalmic Solution 0.06% twice a day |
| FG001 | Bromfenac Ophthalmic Solution 0.03% | Bromfenac Ophthalmic Solution 0.03% twice a day |
| FG002 | Placebo Comparator | Placebo Comparator Placebo Comparator: sterile ophthalmic solution |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bromfenac Ophthalmic Solution 0.06% | Bromfenac Ophthalmic Solution 0.06% twice a day |
| BG001 | Bromfenac Ophthalmic Solution 0.03% | Bromfenac Ophthalmic Solution 0.03% twice a day |
| 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 Ocular Surface Disease Index (OSDI) Total Score | The Ocular Surface Disease Index (OSDI) is a 12 item questionnaire. Each question about discomfort/limitations is scored from 0 to 4, with 0 being 'None of the Time' and 4 being 'All of the Time'. The minimum total score is 0 and the maximum total score is 48, with higher scores indicating worse outcomes. | Posted | Mean | Standard Deviation | score on a scale | 42 days |
|
10 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 | Bromfenac Ophthalmic Solution 0.06% | Bromfenac Ophthalmic Solution 0.06% twice a day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Carotid artery disease | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry eye | Eye disorders | MedDRA (13.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health | susan.harris@bauschhealth.com |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Bromfenac Ophthalmic Solution B |
| Drug |
sterile ophthalmic solution |
|
| Placebo Comparator | Drug | sterile ophthalmic solution |
|
| BG002 | Placebo Comparator | Placebo Comparator Placebo Comparator: sterile ophthalmic solution |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 |
| Placebo Comparator |
Placebo Comparator Placebo Comparator: sterile ophthalmic solution |
|
|
| 0 |
| 141 |
| 2 |
| 141 |
| 9 |
| 141 |
| EG001 | Bromfenac Ophthalmic Solution 0.03% | Bromfenac Ophthalmic Solution 0.03% twice a day | 0 | 140 | 3 | 140 | 8 | 140 |
| EG002 | Placebo Comparator | Placebo Comparator Placebo Comparator: sterile ophthalmic solution | 0 | 139 | 1 | 139 | 7 | 139 |
| Cerebrovascular event | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Diverticulum | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Gastritis atrophic | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Upper Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Mental status change | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
Contact sponsor directly for details.