Safety and Tolerability of SENSIMED Triggerfish in Glaucoma Patients09/02NCT00966108
SENSIMED Triggerfish Discomfort During IOP Monitoring
An observational study of Safety and Tolerability of SENSIMED Triggerfish in Glaucoma Patients, run by Sensimed AG at 1 site in Germany.
Trial summary
Evaluation of the wearing discomfort (safety and tolerability) involved during IOP monitoring with the SENISMED Triggerfish, a sensor embedded in a telemetric contact lens Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety and Tolerability of SENSIMED Triggerfish in Glaucoma Patients
- What is being tested?
- SENSIMED Triggerfish
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2009to Jan 2010
- Phase
- Observational
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy subjects and glaucoma patients
Who may be able to join
- Patient is able to comply with the study procedure
- Patient is 18-80 years old
- Healthy subject or glaucoma patient
- Patient has consented to be in the trial and signed informed consent is available before any study related procedures are carried out
- Cylinder refraction of no more than +/- 2 diopters in the study eye
- Visual acuity of 20/80 or better in the study eye
- Ability of subject to understand the character and individual consequences of the study
- For women with childbearing potential, adequate contraception
Who cannot join
- Subjects wearing contact lenses within the last two years
- Subjects with contraindications for wearing contact lenses
- History of refractive surgery
- History of intraocular surgery in the last three months
- Severe dry eye syndrome
- Keratoconus or other corneal abnormalities
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- Conjunctival or intraocular inflammation
- Pregnancy and lactation
- Simultaneous participation in other clinical trials
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Rhineland-Palatinate, 55131
About this study
Official title: Evaluation of SENSIMED Triggerfish for 24 Hour IOP Monitoring in Healthy Subjects and Glaucoma Patients
Evaluation of the wearing discomfort (safety and tolerability) involved during IOP monitoring with the SENISMED Triggerfish, a sensor embedded in a telemetric contact lens
- Being tested
- SENSIMED Triggerfish
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SENSIMED TriggerfishDevice
Ocular Telemetry Sensor for IOP monitoring
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Not described Receives: Device: SENSIMED Triggerfish | |
| Glaucoma patients | Not described Receives: Device: SENSIMED Triggerfish |
What is being measured
The primary outcome is the main question the study is designed to answer.
ocular discomfort on a visual analogue scale
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and Tolerability of SENSIMED Triggerfish in Glaucoma PatientsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sensimed AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Norbert Pfeiffer, Prof. Dr. med., Principal investigator, Universitätsmedizin Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966108
- Sponsor's protocol ID
- 09/02
- Acronym
- 09/02
- Status last verified
- Feb 2010
- First submitted
- 24 Aug 2009
- Last updated
- 4 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of SENSIMED Triggerfish for 24 Hour IOP Monitoring in Healthy Subjects and Glaucoma Patients
- ClinicalTrials.gov ID
- NCT00966108
- Acronym / sponsor ID
- 09/02 / 09/02
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sensimed AGIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 26 Aug 2009 (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.
Evaluation of the wearing discomfort (safety and tolerability) involved during IOP monitoring with the SENISMED Triggerfish, a sensor embedded in a telemetric contact lens
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | Device: SENSIMED Triggerfish |
| Glaucoma patients | – | Device: SENSIMED Triggerfish |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects and glaucoma patients
Key inclusion criteria (8 listed)
- Patient is able to comply with the study procedure
- Patient is 18-80 years old
- Healthy subject or glaucoma patient
- Patient has consented to be in the trial and signed informed consent is available before any study related procedures are carried out
- Cylinder refraction of no more than +/- 2 diopters in the study eye
Key exclusion criteria (9 listed)
- Subjects wearing contact lenses within the last two years
- Subjects with contraindications for wearing contact lenses
- History of refractive surgery
- History of intraocular surgery in the last three months
- Severe dry eye syndrome
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 TriggerfishOcular Telemetry Sensor for IOP monitoring | Device | Glaucoma patients, Healthy subjects |
Primary outcome
ocular discomfort on a visual analogue scale
Time frame: 24 hours
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 4 Feb 2010.
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.
Norbert Pfeiffer, Prof. Dr. med. principal investigator
Universitätsmedizin Mainz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Safety and Tolerability of SENSIMED Triggerfish in Glaucoma Patients, run by Sensimed AG at 1 site in Germany.
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 8 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 4 Feb 2010. 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 Germany. 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?
ocular discomfort on a visual analogue scale (time frame: 24 hours). 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 4 Feb 2010.