The Effects of the Water Drinking Test on Intraocular Pressure

Not Applicable

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Prostaglandin Analogue	SENSIMED Triggerfish	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	SENSIMED Triggerfish	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)

Primary Outcome Measures

Name	Time	Method
24-hour IOP Patterns	24-hour	Assess IOP patterns between day and night time and changes after the WDT.
Intraocular Pressure	24-hours	IOP monitoring sessions will be carried out in ambulatory mode at 4 week intervals (plus/minus 7 days)

Secondary Outcome Measures