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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
23
Comparison of fluctuation of Intraocular pressures with different class of drugs
Hamilton Glaucoma Center, UCSD
La Jolla, California, United States
24-hour IOP Patterns
Assess IOP patterns between day and night time and changes after the WDT.
Time frame: 24-hour
Intraocular Pressure
IOP monitoring sessions will be carried out in ambulatory mode at 4 week intervals (plus/minus 7 days)
Time frame: 24-hours
Ocular Adverse Events
appearance of any device- or non-device-related ocular adverse events
Time frame: 24-hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.