GlaucomaPhase 4NCT01263535
Use of an Ocular Telemetry Sensor in Tafluprost Treated Patients
A Phase 4 study testing SENSIMED Triggerfish in people with Glaucoma, run by Sensimed AG at 1 site in Switzerland.
Trial summary
This clinical trial is designed to investigate the performance of SENSIMED Triggerfish® during 24-hour continuous IOP fluctuation monitoring, defined as the number of valid recording intervals over the 24-hour period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- SENSIMED Triggerfish
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2010to May 2012
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 18 years.
- Untreated IOP of ≥22 mmHg in both eyes.
- Documented, typical glaucomatous visual field (VF) loss (nasal step, or arcuate, paracentral or Seidel's scotoma) determined by automated static threshold perimetry (Octopus 100), and glaucomatous optic nerve head cupping (neural rim notching or saucerization) in both eyes.
- Patients under tafluprost treatment since at least 4 weeks in both eyes.
- Patients who accept signing an informed consent approved by the Ethics Committee.
Who cannot join
- Patients not able to understand the nature of the research
- Patients under tutorship
- Corneal abnormalities in both eyes
- Subjects with contraindications for wearing contact lenses
- History of ocular surgery within the last 3 months
- Known hypersensitivity to tafluprost or to any of its excipients
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- Full-frame metal glasses during monitoring with SENSIMED Triggerfish®
- Pregnancy and lactation
- Simultaneous participation in other clinical research
- Patients with evidence of ocular infection or inflammation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Circadian Continuous Intraocular Pressure Monitoring With SENSIMED Triggerfish® Ocular Telemetry Sensor in Patients on Tafluprost Treatment
This clinical trial is designed to investigate the performance of SENSIMED Triggerfish® during 24-hour continuous IOP fluctuation monitoring, defined as the number of valid recording intervals over the 24-hour period.
The investigation will recruit male and female patients older than 18 years and diagnosed with glaucoma and treated with tafluprost in both eyes. 20 subjects will be enrolled in the study. Patients will be considered enrolled in the study upon signature of informed consent. A screening visit and one 24-hour IOP fluctuation monitoring session during a 36-hour hospitalisation, are planned for each patient.
- Conditions
- Glaucoma
- Being tested
- SENSIMED Triggerfish
- 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
Contact lens-based device for the continuous recording of IOP fluctuations, with a portable recording system
| Study group | Role | What they receive |
|---|---|---|
| SENSIMED Triggerfish | Experimental | Not described Receives: Device: SENSIMED Triggerfish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acquisition of 24-hour Sensor output signal
Performance is assessed as the portion of valid data (actual number of valid data points recorded compared to expected number of recorded data points) during 24-hour recording.
Measured: After 24-hour continuous recording
Secondary outcomes (1)
Possible IOP fluctuation
Fluctuation is defined as a change of 25% or more from the mean Sensor output over 24 hours for each participant.
Measured: After 24-hour recording with study device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2010 (estimated)
- Study startSep 2010
- Primary completionApr 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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sensimed AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01263535
- Sponsor's protocol ID
- 09/06
- Status last verified
- Aug 2012
- First submitted
- 2 Dec 2010
- Last updated
- 28 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circadian Continuous Intraocular Pressure Monitoring With SENSIMED Triggerfish® Ocular Telemetry Sensor in Patients on Tafluprost Treatment
- ClinicalTrials.gov ID
- NCT01263535
- Acronym / sponsor ID
- 09/06
- Conditions
- Glaucoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Sensimed AGIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital, Geneva
- Study start
- Sep 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 20 Dec 2010 (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.
This clinical trial is designed to investigate the performance of SENSIMED Triggerfish® during 24-hour continuous IOP fluctuation monitoring, defined as the number of valid recording intervals over the 24-hour period.
The investigation will recruit male and female patients older than 18 years and diagnosed with glaucoma and treated with tafluprost in both eyes. 20 subjects will be enrolled in the study. Patients will be considered enrolled in the study upon signature of informed consent. A screening visit and one 24-hour IOP fluctuation monitoring session during a 36-hour hospitalisation, are planned for each patient.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SENSIMED Triggerfish | Experimental | Device: SENSIMED Triggerfish |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Older than 18 years.
- Untreated IOP of ≥22 mmHg in both eyes.
- Documented, typical glaucomatous visual field (VF) loss (nasal step, or arcuate, paracentral or Seidel's scotoma) determined by automated static threshold perimetry (Octopus 100), and glaucomatous optic nerve head cupping (neural rim notching or saucerization) in both eyes.
- Patients under tafluprost treatment since at least 4 weeks in both eyes.
- Patients who accept signing an informed consent approved by the Ethics Committee.
Key exclusion criteria (10 listed)
- Patients not able to understand the nature of the research
- Patients under tutorship
- Corneal abnormalities in both eyes
- Subjects with contraindications for wearing contact lenses
- History of ocular surgery within the last 3 months
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 TriggerfishContact lens-based device for the continuous recording of IOP fluctuations, with a portable recording system | Device | SENSIMED Triggerfish |
Primary outcome
Acquisition of 24-hour Sensor output signal
Time frame: After 24-hour continuous recording
Performance is assessed as the portion of valid data (actual number of valid data points recorded compared to expected number of recorded data points) during 24-hour recording.
1 secondary outcome
Possible IOP fluctuation
Time frame: After 24-hour recording with study device
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SENSIMED Triggerfish in people with Glaucoma, 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 10 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 28 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. 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?
Acquisition of 24-hour Sensor output signal (time frame: After 24-hour continuous recording). 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 28 Aug 2012.