Glaucoma
Conditions
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.
Interventions
DEVICESENSIMED Triggerfish
Comparison of fluctuation of Intraocular pressures with different class of drugs
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Ocular Adverse Events | 24-hours | appearance of any device- or non-device-related ocular adverse events |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| ALL PARTICIPANTS | 0 |
| Total | 0 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
24-hour IOP Patterns
Assess IOP patterns between day and night time and changes after the WDT.
Time frame: 24-hour
Population: 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.
Primary
Intraocular Pressure
IOP monitoring sessions will be carried out in ambulatory mode at 4 week intervals (plus/minus 7 days)
Time frame: 24-hours
Population: 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.
Secondary
Ocular Adverse Events
appearance of any device- or non-device-related ocular adverse events
Time frame: 24-hours
Population: 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.