Ocular HypertensionNCT02030886
IOP Patterns in Ocular Hypertensive Patients Newly Converted to Glaucoma vs Stable Ocular Hypertensive Patients
A study testing Sensimed Triggersfish® (TF) in people with Ocular Hypertension, run by Sensimed AG at 1 site in United States.
Trial summary
The purpose of the study is to assess the relationship between IOP pattern as recorded over 24 hours by using Triggerfish and quantified by acrophase scored dichotomously, and conversion to glaucoma in OHT patients (conversion status). Elevation of IOP above normal range is called "ocular hypertension" (OHT). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Ocular Hypertension
- What is being tested?
- Sensimed Triggersfish® (TF)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Jun 2015
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of OHT (IOP >21 mmHg on 2 consecutive visits) in the study eye
- No IOP-lowering drug treatment in the study eye; otherwise, a 4-week wash-out period prior to study day 0 (SD0) and throughout the study
- Aged ≥ 18 years, of either sex
- Not more than 6 diopters spherical equivalent in the study eye
- Having given written informed consent, prior to any investigational procedures
Who cannot join
- Narrow iridocorneal angle or any other concomitant ocular conditions (except cataract) in the study eye
- History of ocular surgery on the study eye (except cataract extraction)
- History of laser treatment on the study eye
- Corneal or conjunctival abnormality in the study eye, precluding contact lens adaptation
- Severe dry eye syndrome
- Subjects with irregular sleep schedules
Show all 12Show fewer
- Subjects who are current smokers
- Subjects with allergy to corneal anesthetic
- Subjects with contraindications for silicone contact lens wear
- Subjects not able to understand the character and individual consequences of the investigation
- Participation in other clinical research within the last 4 weeks
- Any other contra-indication listed in the TF user manual
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Open Label, Prospective Study Assessing the 24-hour IOP Patterns Using SENSIMED Triggerfish® in Ocular Hypertensive Patients Newly Converted to Glaucomatous Disease Versus Stable Ocular Hypertensive Patients
The purpose of the study is to assess the relationship between IOP pattern as recorded over 24 hours by using Triggerfish and quantified by acrophase scored dichotomously, and conversion to glaucoma in OHT patients (conversion status). Elevation of IOP above normal range is called "ocular hypertension" (OHT). In a previous study, it has been shown that OHT patients who progress to glaucoma (converters) have at baseline and prior to any conversion, IOP patterns that more closely resemble those of established early primary open-angle glaucoma (POAG) patients, while stable OHT patients (non-converters) have IOP patterns closer to those of healthy control subjects. The study has been planned to recruit at least 48 eligible patients (24 converters and 24 non-converters).
- Conditions
- Ocular Hypertension
- Being tested
- Sensimed Triggersfish® (TF)
- Medical subject headings
- Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensimed Triggersfish® (TF)Device
All subjects will be monitored by Sensimed Triggerfish (TF) for 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Ocular hypertension subjects | Other | All subjects will be monitored by Sensimed Triggerfish (TF) for 24 hours. Receives: Device: Sensimed Triggersfish® (TF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship Between Intraocular Pressure (IOP) Pattern as Recorded by TF, and Quantified by Acrophase Scored Dichotomously, and Conversion to Glaucoma in Ocular Hypertension (OHT) Patients (Conversion Status)
For each subject, TF acrophase (ie. time when peak occured) was scored dichotomously (before and after 7 am) and compared between OHT converters and non converters patients.
One subject was removed from the analysis because of invalid TF output.
Measured: 24 hours
Secondary outcomes (2)
Acrophase Scored Continuously (i.e. Actual Time of TF Peak Occurrence)
Mean TF acrophase (ie. actual time when peak occured) was compared between OHT converters and non converters.
One subject was removed from the analysis because of invalid TF output.
Measured: 24 hours
Amplitude of Best-fitting Cosine Curve to 24-hour TF Measurements
This represents an estimate of the magnitude of 24-hour IOP-related variation. One subject was removed from the analysis because of invalid TF output.
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 posted9 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: Low recruitment rate
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.
- Other trials for Ocular HypertensionStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sensimed AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Yale University
- Responsible party
- Sponsor
- Investigators
- Ji Liu, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030886
- Sponsor's protocol ID
- TF-1302
- Status last verified
- Sep 2020
- First submitted
- 30 Dec 2013
- Last updated
- 20 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open Label, Prospective Study Assessing the 24-hour IOP Patterns Using SENSIMED Triggerfish® in Ocular Hypertensive Patients Newly Converted to Glaucomatous Disease Versus Stable Ocular Hypertensive Patients
- ClinicalTrials.gov ID
- NCT02030886
- Acronym / sponsor ID
- TF-1302
- Conditions
- Ocular Hypertension
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment rate
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sensimed AGIndustry (pharma, biotech, devices)
- Collaborators
- Yale University
- Study start
- Dec 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 9 Jan 2014 (estimated)
- Results
- Posted 25 Sep 2020
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 study is to assess the relationship between IOP pattern as recorded over 24 hours by using Triggerfish and quantified by acrophase scored dichotomously, and conversion to glaucoma in OHT patients (conversion status). Elevation of IOP above normal range is called "ocular hypertension" (OHT). In a previous study, it has been shown that OHT patients who progress to glaucoma (converters) have at baseline and prior to any conversion, IOP patterns that more closely resemble those of established early primary open-angle glaucoma (POAG) patients, while stable OHT patients (non-converters) have IOP patterns closer to those of healthy control subjects. The study has been planned to recruit at least 48 eligible patients (24 converters and 24 non-converters).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ocular hypertension subjects | Other | Device: Sensimed Triggersfish® (TF)All subjects will be monitored by Sensimed Triggerfish (TF) for 24 hours. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of OHT (IOP >21 mmHg on 2 consecutive visits) in the study eye
- No IOP-lowering drug treatment in the study eye; otherwise, a 4-week wash-out period prior to study day 0 (SD0) and throughout the study
- Aged ≥ 18 years, of either sex
- Not more than 6 diopters spherical equivalent in the study eye
- Having given written informed consent, prior to any investigational procedures
Key exclusion criteria (12 listed)
- Narrow iridocorneal angle or any other concomitant ocular conditions (except cataract) in the study eye
- History of ocular surgery on the study eye (except cataract extraction)
- History of laser treatment on the study eye
- Corneal or conjunctival abnormality in the study eye, precluding contact lens adaptation
- 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 Triggersfish® (TF)All subjects will be monitored by Sensimed Triggerfish (TF) for 24 hours. | Device | Ocular hypertension subjects |
Primary outcome
Relationship Between Intraocular Pressure (IOP) Pattern as Recorded by TF, and Quantified by Acrophase Scored Dichotomously, and Conversion to Glaucoma in Ocular Hypertension (OHT) Patients (Conversion Status)
Time frame: 24 hours
For each subject, TF acrophase (ie. time when peak occured) was scored dichotomously (before and after 7 am) and compared between OHT converters and non converters patients. One subject was removed from the analysis because of invalid TF output.
2 secondary outcomes
Acrophase Scored Continuously (i.e. Actual Time of TF Peak Occurrence)
Time frame: 24 hours
Amplitude of Best-fitting Cosine Curve to 24-hour TF Measurements
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ji Liu, MD principal investigator
Yale University
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 Triggersfish® (TF) in people with Ocular Hypertension, 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 5 inclusion and 12 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 20 Oct 2020. 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 25 Sep 2020). 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?
Relationship Between Intraocular Pressure (IOP) Pattern as Recorded by TF, and Quantified by Acrophase Scored Dichotomously, and Conversion to Glaucoma in Ocular Hypertension (OHT) Patients (Conversion Status) (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 20 Oct 2020.