The Effects of the Water Drinking Test on Intraocular Pressure

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effects of the Water Drinking Test on Intraocular Pressure of Glaucoma Patients Undergoing 24 Hour Continuous Monitoring With the SENSIMED Triggerfish

Conditions
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Glaucoma

Intervention / Treatment
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* Device: SENSIMED Triggerfish


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is able to comply with the study procedures 18-80 years old Subjects diagnosed with glaucoma, based on presence of repeatable visual field loss and/or glaucomatous optic neuropathy based on masked review of optic disc stereophotographs and under ocular hypotensive treatment, or diagnosed with ocular hypertension, with an IOP of > 22 mmHg at the screening visit and under ocular hypotensive treatment. Subject has consented to be in the trial Visual acuity of 20/80 or better Ability to understand the character and individual consequences of the study For women of childbearing potential, adequate contraception Stable anti-hypertensive treatment regimen 4 weeks prior to the screening visit and throughout the study. Exclusion criteria Subjects with chronic kidney failure and chronic hear disease Subjects with contraindications for wearing contact lenses Severe dry eye syndrome Keratoconus or other corneal abnormality Conjunctival or intraocular inflammation Eye surgery prior to and throughout the study, except prior uncomplicated cataract surgery and laser a minimum of 3 months prior to the screening visit. Full frame metal glasses during SENSIMED Triggerfish® monitoring Known hypersensitivity to silicone, plaster or ocular anesthesia (proparacaine) Pregnancy and lactation Simultaneous participation in other clinical studies No patient will be allowed to participate in this trial more than once

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prostaglandin Analogue<br>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) | Device: SENSIMED Triggerfish<br>* Comparison of fluctuation of Intraocular pressures with different class of drugs<br>* Other names: bimatoprost (Lumigan); brinzolamide (azopt);|
| Active Comparator: Carbonic Anhydrase Inhibitor<br>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) | Device: SENSIMED Triggerfish<br>* Comparison of fluctuation of Intraocular pressures with different class of drugs<br>* Other names: bimatoprost (Lumigan); brinzolamide (azopt);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Adverse Events | appearance of any device- or non-device-related ocular adverse events | 24-hours |