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This clinical trial is designed to investigate the efficacy profile of the SENSIMED Triggerfish® during 24-hour IOP monitoring in patients with glaucoma or ocular hypertension, done three times at monthly intervals under different therapeutic regimen. This trial will also evaluate the efficacy of SENSIMED Triggerfish® to detect changes in intraocular pressure (IOP) after the water drinking test (WDT) will be investigated.
The investigation will recruit male and female patients 18-80 years old and diagnosed with glaucoma or ocular hypertension requiring hypotensive ocular treatment. Up to 100 subjects will be enrolled in the study to ensure a minimum of 80 completing three IOP fluctuation monitoring sessions. Patients will be considered enrolled in the study upon signature of informed consent. A screening visit and three 26-hour IOP fluctuation monitoring sessions are planned for each patient. IOP monitoring sessions will be carried out in ambulatory mode at 4 week intervals (plus/minus 7 days). All subjects will be monitored during the same period of the day (± 1hr). The expected duration of participation for each patient is of 3.5 days over three to four months. Patients will be recruited over a 16-month period. The total expected study duration is 16 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prostaglandin Analogue | Active Comparator | WDT protocol Visit 1 - (WDT after washout) 20 Visit 2 - (WDT with treatment) 20 Visit 3 - (WDT with PGA or BB add-on) 20 (PGA + BB) |
|
| Carbonic Anhydrase Inhibitor | Active Comparator | WDT protocol Visit 1 - (WDT after washout) 20 Visit 2 - (WDT with treatment) 20 Visit 3 - (WDT with PGA or BB add-on) 20 (CAI+ BB) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SENSIMED Triggerfish | Device | Comparison of fluctuation of Intraocular pressures with different class of drugs |
|
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour IOP Patterns | Assess IOP patterns between day and night time and changes after the WDT. | 24-hour |
| Intraocular Pressure | IOP monitoring sessions will be carried out in ambulatory mode at 4 week intervals (plus/minus 7 days) | 24-hours |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Adverse Events | appearance of any device- or non-device-related ocular adverse events | 24-hours |
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Inclusion Criteria:
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Kaweh Mansouri, MD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton Glaucoma Center, UCSD | La Jolla | California | 92093 | United States |
The PI has left the institution and the study data can not be located. Multiple attempts where made to reach the study team, so there are no results to report.
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| ID | Title | Description |
|---|---|---|
| FG000 | ALL PARTICIPANTS |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The PI has left the institution and the study data can not be located. Multiple attempts where made to reach the study team, so there are no results to report.
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| ID | Title | Description |
|---|---|---|
| BG000 | ALL PARTICIPANTS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous |
| 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 | 24-hour IOP Patterns | Assess IOP patterns between day and night time and changes after the WDT. | The PI has left the institution and the study data can not be located. Multiple attempts where made to reach the study team, so there are no results to report. | Posted | 24-hour |
|
|
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The PI has left the institution and the study data can not be located. Multiple attempts where made to reach the study team, so there are no results to report.
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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 | ALL PARTICIPANTS | 0 | 0 |
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The PI has left the institution and the study data can not be located. Multiple attempts where made to reach the study team, so there are no results to report.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eunice Williams-Steppe | ucsdmed | 8588221133 | emwilliamssteppe@ucsd.edu |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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|
| years |
| Sex: Female, Male |
|
| Primary | Intraocular Pressure | IOP monitoring sessions will be carried out in ambulatory mode at 4 week intervals (plus/minus 7 days) | The PI has left the institution and the study data can not be located. Multiple attempts where made to reach the study team, so there are no results to report. | Posted | 24-hours |
|
|
| Secondary | Ocular Adverse Events | appearance of any device- or non-device-related ocular adverse events | The PI has left the institution and the study data can not be located. Multiple attempts where made to reach the study team, so there are no results to report. | Posted | 24-hours |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
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