Healthy SubjectsNCT01362868
Water Drinking Test During Intraocular Pressure Fluctuation (IOP) Monitoring
A study testing SENSIMED Triggerfish® in people with Healthy Subjects, run by Sensimed AG at 1 site in Switzerland.
Trial summary
The purpose of this study is to investigate the investigational device capacity to detect an intraocular pressure increase (IOP)induced by water intake. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- SENSIMED Triggerfish®
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2011to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteer without previous ocular medical history
- 18 years or more at inclusion
- Maximal weight: 100kg
- BMI lower or equal to 30 kg/m2
- Subjects having provided informed consent
Who cannot join
- Silicone allergy
- Cardiovascular disease
- Diabetes
- Narrow or closed iridocorneal angle
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Unité de Glaucome, Clinique de Montchoisi
Lausanne, 1006
About this study
Official title: Water Drinking Test (WDT) During Continuous Recording of Intraocular Pressure Fluctuation
The purpose of this study is to investigate the investigational device capacity to detect an intraocular pressure increase (IOP)induced by water intake.
Read the detailed description
32 subjects will be enrolled in the investigation. Eligible subjects will receive one session of 4-6-hour continuous IOP monitoring with SENSIMED Triggerfish® following water drinking test (WDT). SENSIMED Triggerfish® will be installed randomly on right or left eyes and the IOP recording will be initiated as soon as the adaptation of the device on the subject's eye is satisfying. Sensor fitting in the eye will then be evaluated every 60 minutes, until no more spontaneous Sensor movement and rotation are observed. Then IOP will be measured on the contra lateral eye using Goldmann tonometer and the subjects will be asked to drink 1 liter of water within 5 minutes.
After the water drinking, IOP will be measured on the contra lateral eye 10 minutes after the beginning of the test then every 5 minutes until returned to normal. The IOP will be measured again every 20 minutes until 2 hours after the water drinking.
- Conditions
- Healthy Subjects
- Being tested
- SENSIMED Triggerfish®
- Keywords
- Glaucoma, Triggerfish, Water drinking test
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SENSIMED Triggerfish®Device
Soft contact lens-based device for the continuous monitoring of IOP fluctuations
What is being measured
The primary outcome is the main question the study is designed to answer.
SENSIMED Triggerfish® signal increase when Goldman IOP increase is ≥ 3 mmHg following WDT
Measured: 30-45 min after WDT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2011 (estimated)
- Study startMay 2011
- Primary completionNov 2011
- Study completionNov 2011
Why it stopped: Too low effect on the output and low rate of responders
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sensimed AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- André Mermoud, MD, Principal investigator, Clinique de Montchoisi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01362868
- Sponsor's protocol ID
- 1012
- Status last verified
- Nov 2011
- First submitted
- 27 May 2011
- Last updated
- 9 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Water Drinking Test (WDT) During Continuous Recording of Intraocular Pressure Fluctuation
- ClinicalTrials.gov ID
- NCT01362868
- Acronym / sponsor ID
- 1012
- Conditions
- Healthy Subjects
- Keywords
- Glaucoma, Triggerfish, Water drinking test
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Too low effect on the output and low rate of responders
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Sensimed AGIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 30 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the investigational device capacity to detect an intraocular pressure increase (IOP)induced by water intake.
Detailed description
32 subjects will be enrolled in the investigation. Eligible subjects will receive one session of 4-6-hour continuous IOP monitoring with SENSIMED Triggerfish® following water drinking test (WDT). SENSIMED Triggerfish® will be installed randomly on right or left eyes and the IOP recording will be initiated as soon as the adaptation of the device on the subject's eye is satisfying. Sensor fitting in the eye will then be evaluated every 60 minutes, until no more spontaneous Sensor movement and rotation are observed. Then IOP will be measured on the contra lateral eye using Goldmann tonometer and the subjects will be asked to drink 1 liter of water within 5 minutes.
After the water drinking, IOP will be measured on the contra lateral eye 10 minutes after the beginning of the test then every 5 minutes until returned to normal. The IOP will be measured again every 20 minutes until 2 hours after the water drinking.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy volunteer without previous ocular medical history
- 18 years or more at inclusion
- Maximal weight: 100kg
- BMI lower or equal to 30 kg/m2
- Subjects having provided informed consent
Key exclusion criteria (4 listed)
- Silicone allergy
- Cardiovascular disease
- Diabetes
- Narrow or closed iridocorneal angle
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SENSIMED Triggerfish®Soft contact lens-based device for the continuous monitoring of IOP fluctuations | Device | – |
Primary outcome
SENSIMED Triggerfish® signal increase when Goldman IOP increase is ≥ 3 mmHg following WDT
Time frame: 30-45 min after WDT
Results and safety
The study was stopped early (reason given: Too low effect on the output and low rate of responders). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
André Mermoud, MD principal investigator
Clinique de Montchoisi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SENSIMED Triggerfish® in people with Healthy Subjects, run by Sensimed AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Too low effect on the output and low rate of responders). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SENSIMED Triggerfish® signal increase when Goldman IOP increase is ≥ 3 mmHg following WDT (time frame: 30-45 min after WDT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2011.