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The purpose of this study is to evaluate the ocular safety and efficacy of a glaucoma drug delivery system in open-angle glaucoma or ocular hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Dose Device | Experimental | device worn continuously for 14 days |
|
| Low Dose Device | Experimental | device worn continuously for 14 days |
|
| Placebo Device | Placebo Comparator | device worn continuously for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Dose Device | Drug | inserted for 14 days |
| |
| Low Dose Device |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity - Right Eye | This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR). The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal. | at 14 days |
| Visual Acuity - Left Eye | This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR. The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal. | at 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure (IOP) | from baseline to 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Artesia | California | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | High Dose Bimatoprost Punctal Plug | punctal plug with bimatoprost, high dose |
| FG001 | Low Dose Bimatoprost Punctal Plug | punctal plug with bimatoprost, low dose |
| FG002 | Placebo | punctal plug without bimatoprost |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Dose Bimatoprost Punctal Plug | punctal plug with bimatoprost, high dose |
| BG001 | Low Dose Bimatoprost Punctal Plug | punctal plug with bimatoprost, low dose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | This baseline measure includes all subjects with a plug insertion. |
| 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 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Intraocular Pressure (IOP) | The analysis population includes all subjects with a plug insertion that completed the study per protocol. | Posted | Mean | Standard Deviation | mmHg | from baseline to 14 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 | High Dose Bimatoprost Punctal Plug | punctal plug with bimatoprost, high dose |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cerebrovascular accident | Nervous system disorders | unrelated to study treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Foreign body sensation | Eye disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Schwam MD/Director Clinical Affairs & Ocular Sciences | Vistakon | 904-443-1482 |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| Drug |
inserted for 14 days |
|
| Placebo Device | Device | inserted for 14 days |
|
| Louisville |
| Kentucky |
| United States |
| Baltimore | Maryland | USA | United States |
| Mt. Pleasant | South Carolina | United States |
| BG002 | Placebo | punctal plug without bimatoprost |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Primary | Visual Acuity - Right Eye | This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR). The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal. | Posted | Mean | Standard Deviation | logMAR units | at 14 days |
|
|
|
| Primary | Visual Acuity - Left Eye | This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR. The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal. | Posted | Mean | Standard Deviation | logMARs | at 14 days |
|
|
|
| 1 |
| 16 |
| 13 |
| 16 |
| EG001 | Low Dose Bimatoprost Punctal Plug | punctal plug with bimatoprost, low dose | 0 | 15 | 11 | 15 |
| EG002 | Placebo | punctal plug without bimatoprost | 0 | 20 | 11 | 20 |
| Eye pain | Eye disorders |
|
| abnormal sensation in eyes | Eye disorders |
|
| Conjunctival hyperaemia | Eye disorders |
|
| corneal erosion | Eye disorders |
|
| dry eye | Eye disorders |
|
| erythema of eyelid | Eye disorders |
|
| eye irritation | Eye disorders |
|
| eye puritus | Eye disorders |
|
| eyelid margin crusting | Eye disorders |
|
| eyelid pain | Eye disorders |
|
| eyelids puritus | Eye disorders |
|
| inflammation of lacrimal passage | Eye disorders |
|
| lacrimation increased | Eye disorders |
|
| ocular hyperaemia | Eye disorders |
|
| visual acuity reduced | Eye disorders |
|
| upper respiratory tract infection | Infections and infestations |
|
| contusion | Injury, poisoning and procedural complications |
|
| procedural complication | Injury, poisoning and procedural complications |
|
| musculoskeletal chest pain | Musculoskeletal and connective tissue disorders |
|
| sinus headache | Nervous system disorders |
|
Prior to submission for publication or presentation, the PI will provide the Sponsor 60 days for review of the manuscript. The Sponsor may request that the PI withhold the publication for an additional 60 days.