GlaucomaNCT01028664
Use of an Ocular Telemetry Sensor in Diamox Treated Patients
A study testing SENSIMED Triggerfish in people with Glaucoma and Ocular Hypertension, run by Sensimed AG at 1 site in Switzerland.
Trial summary
A soft contact lens integrating a Sensor is placed on subjects with high intraocular pressure (IOP) after administration of an IOP-lowering drug to investigate the device's capacity to detect the induced IOP reduction. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glaucoma, Ocular Hypertension
- 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
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2009to Oct 2010
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of glaucoma or ocular hypertension
- IOP of ≥ 15 mmHg.
- Patients of either gender.
- Older than 18 years.
- 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 Diamox® or to any of its excipients
Show all 10Show fewer
- Pregnancy and lactation
- Simultaneous participation in other clinical research
- Patients with evidence of ocular infection or inflammation
- History of renal or hepatic impairment, hypokalemia and hyponatremia
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Clinique de Montchoisi, Centre du Glaucome
Lausanne, 1006
About this study
Official title: Detection of IOP Fluctuation With SENSIMED Triggerfish in Patients With Glaucoma or Ocular Hypertension Treated With Diamox
A soft contact lens integrating a Sensor is placed on subjects with high intraocular pressure (IOP) after administration of an IOP-lowering drug to investigate the device's capacity to detect the induced IOP reduction.
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- SENSIMED Triggerfish
- Keywords
- Glaucoma and ocular hypertension patients
- Medical subject headings
- Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SENSIMED TriggerfishDevice
2-hour continuous IOP monitoring
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma or ocular hypertension patients | Experimental | Not described Receives: Device: SENSIMED Triggerfish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of IOP reduction 2 hours after Diamox administration
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionOct 2010
- Study completionOct 2010
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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sensimed AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinique de Montchoisi, Lausanne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01028664
- Sponsor's protocol ID
- 09/05
- Status last verified
- Dec 2010
- First submitted
- 7 Dec 2009
- Last updated
- 3 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of IOP Fluctuation With SENSIMED Triggerfish in Patients With Glaucoma or Ocular Hypertension Treated With Diamox
- ClinicalTrials.gov ID
- NCT01028664
- Acronym / sponsor ID
- 09/05
- Conditions
- Glaucoma, Ocular Hypertension
- Keywords
- Glaucoma and ocular hypertension patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sensimed AGIndustry (pharma, biotech, devices)
- Collaborators
- Clinique de Montchoisi, Lausanne, Switzerland
- Study start
- Dec 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 9 Dec 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.
A soft contact lens integrating a Sensor is placed on subjects with high intraocular pressure (IOP) after administration of an IOP-lowering drug to investigate the device's capacity to detect the induced IOP reduction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glaucoma or ocular hypertension patients | Experimental | Device: SENSIMED Triggerfish |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed diagnosis of glaucoma or ocular hypertension
- IOP of ≥ 15 mmHg.
- Patients of either gender.
- Older than 18 years.
- 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 Triggerfish2-hour continuous IOP monitoring | Device | Glaucoma or ocular hypertension patients |
Primary outcome
Detection of IOP reduction 2 hours after Diamox administration
Time frame: 2 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 3 Dec 2010.
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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 study testing SENSIMED Triggerfish in people with Glaucoma and Ocular Hypertension, 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: finished, as of the sponsor's last update on 3 Dec 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 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?
Detection of IOP reduction 2 hours after Diamox administration (time frame: 2 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 3 Dec 2010.