GlaucomaNCT01319617
SENSIMED Triggerfish Safety and Tolerability
A study testing SENSIMED Triggerfish in people with Glaucoma, run by Sensimed AG at 1 site in United States.
Trial summary
The purpose of this investigation is to study the safety and tolerability of SENSIMED Triggerfish, a soft contact lens-based device intended to continuously record relative changes in intraocular pressure (IOP). The investigation enrols glaucoma patients and glaucoma suspects. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- 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
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Nov 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subject is able to comply with the study procedures
- Subject is 18-80 years old
- Glaucoma patient, with glaucomatous optic neuropathy based on clinical assessment of stereoscopic optic disc photographs and/or repeatable abnormal standard automated perimetry (SAP) visual fields at baseline, defined as a pattern standard deviation with P<0.05 or a glaucoma Hemifield test "outside normal limits
- Glaucoma suspect, with suspicious optic disc appearance (as determined by subjective assessment on the baseline visit) or elevated IOP (>21 mmHg) but normal and reliable SAP visual fields at baseline
- Subject has consented to be in the trial and signed informed consent is available before any study related procedures are carried out
- Visual acuity of 20/200 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 with contraindications for wearing contact lenses
- Severe dry eye syndrome
- Keratoconus or other corneal abnormality
- Conjunctival or intraocular inflammation
- Eye surgery prior to and throughout the study, except prior uncomplicated cataract surgery a minimum of 3 months prior to the investigation
- Full frame metal glasses during SENSIMED Triggerfish® recording
Show all 9Show fewer
- Known hypersensitivity to silicone, plaster or ocular anesthesia
- Pregnancy and lactation
- Simultaneous participation in other clinical studies
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
San Diego, California, 92093-0946
About this study
Official title: Evaluation of SENSIMED Triggerfish Safety and Tolerability in Glaucoma Patients and Glaucoma Suspects
The purpose of this investigation is to study the safety and tolerability of SENSIMED Triggerfish, a soft contact lens-based device intended to continuously record relative changes in intraocular pressure (IOP). The investigation enrols glaucoma patients and glaucoma suspects. All subjects receive two 24-hour recording sessions with the device in an ambulatory setting and at weekly interval. The level of discomfort in the study eye after 24 hours and side effects are the main endpoints of the investigation.
- 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
Soft contact lens-based device intended for continuous recording of relative changes in IOP
| 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.
Ocular Discomfort
Ocular discomfort in the study eye is reported by patients on a 100-mm visual analog scale (left end 0 mm, no discomfort; right end 100 mm, very severe discomfort) as the distance from the left end to the patient's mark after wearing the device for 24 hours at two occasions separated by one week. Values for both sessions were averaged.
Measured: After 24 hours of 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 startJan 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sensimed AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Felipe Medeiros, MD, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01319617
- Sponsor's protocol ID
- 10/05
- Status last verified
- Sep 2013
- First submitted
- 18 Mar 2011
- Last updated
- 9 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Mansouri K, Medeiros FA, Tafreshi A, Weinreb RN. Continuous 24-hour monitoring of intraocular pressure patterns with a contact lens sensor: safety, tolerability, and reproducibility in patients with glaucoma. Arch Ophthalmol. 2012 Dec;130(12):1534-9. doi: 10.1001/jamaophthalmol.2013.1350.
PubMed 23229696Mansouri K, Liu JH, Weinreb RN, Tafreshi A, Medeiros FA. Analysis of continuous 24-hour intraocular pressure patterns in glaucoma. Invest Ophthalmol Vis Sci. 2012 Dec 13;53(13):8050-6. doi: 10.1167/iovs.12-10569.
PubMed 23139273Mansouri K, Medeiros FA, Tafreshi A, Weinreb RN. Continuous 24-hour monitoring of intraocular pressure patterns with a contact lens sensor: safety, tolerability, and reproducibility in patients with glaucoma. Arch Ophthalmol. 2012 Dec;130(12):1534-9. doi: 10.1001/archophthalmol.2012.2280.
PubMed 22892888
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of SENSIMED Triggerfish Safety and Tolerability in Glaucoma Patients and Glaucoma Suspects
- ClinicalTrials.gov ID
- NCT01319617
- Acronym / sponsor ID
- 10/05
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Sensimed AGIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 21 Mar 2011 (estimated)
- Results
- Posted 9 Sep 2013
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 investigation is to study the safety and tolerability of SENSIMED Triggerfish, a soft contact lens-based device intended to continuously record relative changes in intraocular pressure (IOP). The investigation enrols glaucoma patients and glaucoma suspects. All subjects receive two 24-hour recording sessions with the device in an ambulatory setting and at weekly interval. The level of discomfort in the study eye after 24 hours and side effects are the main endpoints of the investigation.
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 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is able to comply with the study procedures
- Subject is 18-80 years old
- Glaucoma patient, with glaucomatous optic neuropathy based on clinical assessment of stereoscopic optic disc photographs and/or repeatable abnormal standard automated perimetry (SAP) visual fields at baseline, defined as a pattern standard deviation with P<0.05 or a glaucoma Hemifield test "outside normal limits
- Glaucoma suspect, with suspicious optic disc appearance (as determined by subjective assessment on the baseline visit) or elevated IOP (>21 mmHg) but normal and reliable SAP visual fields at baseline
- Subject has consented to be in the trial and signed informed consent is available before any study related procedures are carried out
Key exclusion criteria (9 listed)
- Subjects with contraindications for wearing contact lenses
- Severe dry eye syndrome
- Keratoconus or other corneal abnormality
- Conjunctival or intraocular inflammation
- Eye surgery prior to and throughout the study, except prior uncomplicated cataract surgery a minimum of 3 months prior to the investigation
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 intended for continuous recording of relative changes in IOP | Device | SENSIMED Triggerfish |
Primary outcome
Ocular Discomfort
Time frame: After 24 hours of device wear
Ocular discomfort in the study eye is reported by patients on a 100-mm visual analog scale (left end 0 mm, no discomfort; right end 100 mm, very severe discomfort) as the distance from the left end to the patient's mark after wearing the device for 24 hours at two occasions separated by one week. Values for both sessions were averaged.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23229696Mansouri K, Medeiros FA, Tafreshi A, Weinreb RN. Continuous 24-hour monitoring of intraocular pressure patterns with a contact lens sensor: safety, tolerability, and reproducibility in patients with glaucoma. Arch Ophthalmol. 2012 Dec;130(12):1534-9. doi: 10.1001/jamaophthalmol.2013.1350.
- Derived from this study: PubMed 23139273Mansouri K, Liu JH, Weinreb RN, Tafreshi A, Medeiros FA. Analysis of continuous 24-hour intraocular pressure patterns in glaucoma. Invest Ophthalmol Vis Sci. 2012 Dec 13;53(13):8050-6. doi: 10.1167/iovs.12-10569.
- Derived from this study: PubMed 22892888Mansouri K, Medeiros FA, Tafreshi A, Weinreb RN. Continuous 24-hour monitoring of intraocular pressure patterns with a contact lens sensor: safety, tolerability, and reproducibility in patients with glaucoma. Arch Ophthalmol. 2012 Dec;130(12):1534-9. doi: 10.1001/archophthalmol.2012.2280.
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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.
Felipe Medeiros, MD, PhD principal investigator
University of California, San Diego
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, run by Sensimed AG at 1 site in United States.
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 9 Sep 2013. 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 United States. 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?
Yes. Results are posted in the registry (first posted 9 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (time frame: After 24 hours of device wear). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01319617, which also lists 3 linked publications.
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 Sep 2013.