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Evaluation of the ocular safety and efficacy of a drug delivery system in open-angle glaucoma or ocular hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Dose Drug Device/ bimatoprost 0.03% | Experimental | drug device containing 65 micrograms of bimatoprost released over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period). |
|
| Low Dose Drug Device / bimatoprost 0.03% | Experimental | drug device containing 45 micrograms of bimatoprost released over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period). |
|
| Placebo Device / bimatoprost 0.03% | Other | placebo drug device worn over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Dose Drug Device | Drug | device inserted for 4 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Intraocular Pressure at Day 1 | Baseline to Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Intraocular Pressure at Day 2 | Baseline to Day 2 | |
| Mean Change in Intraocular Pressure at Day 3 | Baseline to Day 3 | |
| Mean Change in Intraocular Pressure at Day 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami | Florida | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | High Dose Drug Device/ Bimatoprost 0.03% | high dose drug device during first period, bimatoprost 0.03% during second period. |
| FG001 | Low Dose Drug Device / Bimatoprost 0.03% | low-dose drug device during first period, bimatoprost 0.03% during second period. |
| FG002 | Placebo Device / Bimatoprost 0.03% | placebo device during first period, bimatoprost 0.03% during second period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Dose Drug Device/ Bimatoprost 0.03% | high dose drug device during first period, bimatoprost 0.03% during second period. |
| BG001 | Low Dose Drug Device / Bimatoprost 0.03% | low-dose drug device during first period, bimatoprost 0.03% during second period. |
| 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 Change in Intraocular Pressure at Day 1 | per-protocol population | Posted | Mean | Standard Deviation | mmHg | Baseline to Day 1 |
|
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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 | High Dose Drug Device/ Bimatoprost 0.03% | high dose drug device during first period, bimatoprost 0.03% during second period. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival Hyperemia | Eye disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Schwam MD | Vistakon | 1-904-443-1482 | bschwam@its.jnj.com |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| Low Dose Drug Device |
| Drug |
device inserted for 4 days |
|
| Placebo Device | Drug | device inserted for 4 days |
|
| bimatoprost 0.03% | Drug | one drop in each eye on one day only |
|
| Baseline to Day 4 |
| Mean Change in Intraocular Pressure at Day 5 | Day 4 to Day 5 |
| Philadelphia |
| Pennsylvania |
| United States |
| Mt. Pleasant | South Carolina | United States |
| Rapid City | South Dakota | United States |
| Maryville | Tennessee | United States |
| BG002 | Placebo Device / Bimatoprost 0.03% | placebo device during first period, bimatoprost 0.03% during second period. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
placebo device during first period, bimatoprost 0.03% during second period.
|
|
| Secondary | Mean Change in Intraocular Pressure at Day 2 | Not Posted | Baseline to Day 2 |
| Secondary | Mean Change in Intraocular Pressure at Day 3 | Not Posted | Baseline to Day 3 |
| Secondary | Mean Change in Intraocular Pressure at Day 4 | Not Posted | Baseline to Day 4 |
| Secondary | Mean Change in Intraocular Pressure at Day 5 | Not Posted | Day 4 to Day 5 |
| 0 |
| 17 |
| 12 |
| 17 |
| EG001 | Low Dose Drug Device / Bimatoprost 0.03% | low-dose drug device during first period, bimatoprost 0.03% during second period. | 0 | 12 | 7 | 12 |
| EG002 | Placebo Device / Bimatoprost 0.03% | placebo device during first period, bimatoprost 0.03% during second period. | 0 | 18 | 8 | 18 |
| Eye Irritation | Eye disorders |
|
| Eye Pain | Eye disorders |
|
| Eye Pruritus | Eye disorders |
|
| Eyelid Pruritus | Eye disorders |
|
| Eyelid Margin Crusting | Eye disorders |
|
| Eyelid Oedema | Eye disorders |
|
| Foreign Body Sensation in Eye | Eye disorders |
|
| Punctate Keratitis | Eye disorders |
|
| Ocular Hyperemia | Eye disorders |
|
| Lid Margin Discharge | Eye disorders |
|
| Abnormal Sensation in Eye | Eye disorders |
|
| Eye Disorder | Eye disorders |
|
| Gingivitis | Gastrointestinal disorders |
|
| Medical Device Complication | Injury, poisoning and procedural complications |
|
| Medical Device Discomfort | Injury, poisoning and procedural complications |
|
| Procedural Pain | Injury, poisoning and procedural complications |
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| Muscle Spasms | Musculoskeletal and connective tissue disorders |
|
| Headache | Nervous system disorders |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders |
|
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