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This is an open-label, observational extension of patients who received POLAT-001 in LipoLat-CS202.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation only | Other | No intervention in this study. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure (IOP) | Mean change from baseline (Visit 1 in Study LipoLat-CS202, NCT02466399) IOP at Month 3 (6 months after treatment in LipoLat-CS202). | 3 months |
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Inclusion criteria
Exclusion criteria
Excluded from the study will be individuals with the following characteristics:
1. The development, during study LipoLat-CS202, of any exclusion criteria from that study (e.g., concomitant medication or co-morbid disease).
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Patients who were randomized to received POLAT-001 and successfully completed LipoLat-CS202
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Professional Research Network | Goose Creek | South Carolina | 29445 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Post Treatment Follow-up | Post treatment follow-up |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Post Treatment Follow-up | Post treatment follow-up |
| 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 | Intraocular Pressure (IOP) | Mean change from baseline (Visit 1 in Study LipoLat-CS202, NCT02466399) IOP at Month 3 (6 months after treatment in LipoLat-CS202). | Per protocol | Posted | Mean | Standard Deviation | mm Hg | 3 months |
|
|
3 months
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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 | Post Treatment Follow-up | Post treatment follow-up | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infections and infestations | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Operating Officer | Peregrine Ophthalmic Pte Ltd | 65 97914382 | jchua@peregrineop.com |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| 18 |
| 0 |
| 18 |
| 16 |
| 18 |
| Musculoskeletal and connective tissue disorders | Eye disorders | MedDRA (17.0) | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA (17.0) | Systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA (17.0) | Systematic Assessment |
|
| Foreign body sensation in eyes | Eye disorders | MedDRA (17.0) | Systematic Assessment |
|
If multi-center study publication not published within two (2) years after the completion of the Study at all sites, Investigator may publish the results of the Study obtained by Investigator with 60 days notice to Sponsor