GlaucomaNCT01319604
SENSIMED Triggerfish
A study testing SENSIMED Triggerfish and Tonometer in people with Glaucoma, run by Sensimed AG at 5 sites in 4 countries.
Trial summary
The purpose of the investigation is to investigate the relationship between the study device output and tonometric assessments. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- SENSIMED Triggerfish and Tonometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Mar 2011to May 2012
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent for the investigation
- Confirmed diagnosis of primary open angle glaucoma or normal tension glaucoma of similar degree in both eyes
- Age 18-85
- Stable anti-glaucomatous therapy 4 weeks before and throughout the investigation
Who cannot join
- Patients not able to understand the character and individual consequences of the investigation
- Patients with contraindications for silicone contact lens wear
- Wear of full frame metallic glasses during SENSIMED Triggerfish® monitoring
- Diagnosis of pseudoexfoliation syndrome / pseudoexfoliative glaucoma and of pigment dispersion syndrome / pigmentary glaucoma
- Severe dry eye
- Patients who have had ocular surgery within the last 3 months
Show all 9Show fewer
- Corneal or conjunctival abnormality or irregularity hindering correct contact lens adaptation
- Allergy to corneal anaesthesia
- Simultaneous participation in other clinical research
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Spain2 sites
Hospital Clínico San Carlos
Madrid, 28040
Hospital Universitari i Politècnic la Fe
Valencia, 46026
About this study
Official title: Randomized Clinical Investigation to Assess the Efficacy of SENSIMED Triggerfish Continuous IOP Monitoring
The purpose of the investigation is to investigate the relationship between the study device output and tonometric assessments.
Read the detailed description
60 subjects will be enrolled in total. Enrolled patients will be randomized into one of 8 device groups of 6 subjects each or into the control group containing 12 subjects. Patients in the device arm will receive one session of 3-to 24-hour continuous IOP monitoring with SENSIMED Triggerfish®. SENSIMED Triggerfish® monitoring will begin at 18h ± 2 hours for all patients. SENSIMED Triggerfish® will be installed randomly on right or left eyes. During SENSIMED Triggerfish® monitoring on one eye, GAT and/or Perkins IOP measurements will be taken in the fellow eye every 3 hours. Outside this time they will receive GAT and/or IOP measurements every 3 hours in both eyes until the end of the 24-hours period. Patients in the control group will receive GAT and/or ICare PRO IOP measurements every 3 hours for 24 hours in both eyes.
- Conditions
- Glaucoma
- Being tested
- SENSIMED Triggerfish, Tonometer
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SENSIMED TriggerfishDevice
Soft contact lens-based device for the continuous monitoring of IOP fluctuations
TonometerDevice
Tonometric assessment of IOP
| Study group | Role | What they receive |
|---|---|---|
| Study device during 3 hours | Experimental | Not described Receives: Device: SENSIMED Triggerfish |
| Study device during 6 hours | Experimental | Not described Receives: Device: SENSIMED Triggerfish |
| Study device during 9 hours | Experimental | Not described Receives: Device: SENSIMED Triggerfish |
| Study device during 12 hours | Experimental | Not described Receives: Device: SENSIMED Triggerfish |
| Study device during 15 hours | Experimental | Not described Receives: Device: SENSIMED Triggerfish |
| Study device during 18 hours | Experimental | Not described Receives: Device: SENSIMED Triggerfish |
| Study device during 21 hours | Experimental | Not described Receives: Device: SENSIMED Triggerfish |
| Study device during 24 hours | Experimental | Not described Receives: Device: SENSIMED Triggerfish |
| Tonometric assessment during 24 hours | Active comparator | Not described Receives: Device: Tonometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between study device signal and tonometer reading
Measured: during 24 hours of study device wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sensimed AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Milko Iliev, MD, Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01319604
- Sponsor's protocol ID
- 10/01
- Status last verified
- Aug 2012
- First submitted
- 18 Mar 2011
- Last updated
- 8 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Investigation to Assess the Efficacy of SENSIMED Triggerfish Continuous IOP Monitoring
- ClinicalTrials.gov ID
- NCT01319604
- Acronym / sponsor ID
- 10/01
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Sensimed AGIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 21 Mar 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 the investigation is to investigate the relationship between the study device output and tonometric assessments.
Detailed description
60 subjects will be enrolled in total. Enrolled patients will be randomized into one of 8 device groups of 6 subjects each or into the control group containing 12 subjects. Patients in the device arm will receive one session of 3-to 24-hour continuous IOP monitoring with SENSIMED Triggerfish®. SENSIMED Triggerfish® monitoring will begin at 18h ± 2 hours for all patients. SENSIMED Triggerfish® will be installed randomly on right or left eyes. During SENSIMED Triggerfish® monitoring on one eye, GAT and/or Perkins IOP measurements will be taken in the fellow eye every 3 hours. Outside this time they will receive GAT and/or IOP measurements every 3 hours in both eyes until the end of the 24-hours period. Patients in the control group will receive GAT and/or ICare PRO IOP measurements every 3 hours for 24 hours in both eyes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Study device during 3 hours | Experimental | Device: SENSIMED Triggerfish |
| Study device during 6 hours | Experimental | Device: SENSIMED Triggerfish |
| Study device during 9 hours | Experimental | Device: SENSIMED Triggerfish |
| Study device during 12 hours | Experimental | Device: SENSIMED Triggerfish |
| Study device during 15 hours | Experimental | Device: SENSIMED Triggerfish |
| Study device during 18 hours | Experimental | Device: SENSIMED Triggerfish |
| Study device during 21 hours | Experimental | Device: SENSIMED Triggerfish |
| Study device during 24 hours | Experimental | Device: SENSIMED Triggerfish |
| Tonometric assessment during 24 hours | Active comparator | Device: Tonometer |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent for the investigation
- Confirmed diagnosis of primary open angle glaucoma or normal tension glaucoma of similar degree in both eyes
- Age 18-85
- Stable anti-glaucomatous therapy 4 weeks before and throughout the investigation
Key exclusion criteria (9 listed)
- Patients not able to understand the character and individual consequences of the investigation
- Patients with contraindications for silicone contact lens wear
- Wear of full frame metallic glasses during SENSIMED Triggerfish® monitoring
- Diagnosis of pseudoexfoliation syndrome / pseudoexfoliative glaucoma and of pigment dispersion syndrome / pigmentary glaucoma
- Severe dry eye
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 TriggerfishSoft contact lens-based device for the continuous monitoring of IOP fluctuations | Device | Study device during 12 hours, Study device during 15 hours, Study device during 18 hours, Study device during 21 hours, Study device during 24 hours, Study device during 3 hours, Study device during 6 hours, Study device during 9 hours |
| TonometerTonometric assessment of IOP | Device | Tonometric assessment during 24 hours |
Primary outcome
Relationship between study device signal and tonometer reading
Time frame: during 24 hours of study device wear
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2012.
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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.
Milko Iliev, MD principal investigator
University of Bern
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SENSIMED Triggerfish and Tonometer in people with Glaucoma, run by Sensimed AG at 5 sites in 4 countries.
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 8 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain, Belgium, Denmark, 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Relationship between study device signal and tonometer reading (time frame: during 24 hours of study device wear). 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 8 Aug 2012.