GlaucomaNCT04024293
Intraocular Pressure Measured by a Novel Sensing Contact Lens Versus Tonometry
A study testing Goldfish (GF) in people with Glaucoma and Ocular Hypertension, run by Sensimed AG at 1 site in Switzerland.
Trial summary
While elevated intraocular pressure (IOP) is no longer part of the definition of glaucoma it remains the sole proven modifiable risk factor for the onset and progression of glaucoma. IOP is known to vary with the time of day as well as with daily activities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Ocular Hypertension
- What is being tested?
- Goldfish (GF)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2025to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Informed Consent
- A clinical diagnosis of primary open angle glaucoma (POAG), including normal tension glaucoma (NTG), for OAG patients
- A clinical diagnosis of OHT, for OHT patients
- For all patients:
- Open angles on gonioscopy Aged ≥ 18 years, either gender Both central corneal radii (CCR) between 7.3mm (46.23D) and 8.05mm (41.93D), with a maximum difference of 2D between the 2 radii in the study eye Central corneal thickness (CCT) between 490µm and 600µm in the study eye
Who cannot join
- Ocular pathology (other than glaucoma or OHT)
- Previous glaucoma, cataract or refractive laser/surgery
- Corneal or conjunctival abnormality, precluding contact lens adaptation
- Insufficiency of lacrimal secretion
- Subjects with allergy to corneal anesthetic
- Subjects with contraindications for silicone contact lens wear
Show all 15Show fewer
- Subjects with contraindications for Diamox or Latanoprost or Timolol
- Skin irritations, skin eczema or other indications against the wearing of adhesive patches
- Subjects unable or unwilling to comply with the study procedures
- Subjects lacking the capacity to consent (vulnerable persons)
- Subjects with history of cardiac failure, treated cardiopathy or renal failure
- Subjects with known cognitive disorders
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- Participation in another study with investigational drug within the 30 days preceding and during the present study,
- Enrolment of the investigator, his/her family members, employees and other dependent persons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Clinique Montchoisi
Lausanne, Canton of Vaud, 1006
Kaweh Mansouri, Pr, +41 21 619 36 02, kwmansouri@gmail.com
About this study
Official title: A Prospective Single Center Open Label Study Assessing Intraocular Pressure Measurements Using a Novel Sensing Contact Lens-based Device as Compared to Standard Tonometry, in Open Angle Glaucoma and Ocular Hypertensive Patients
While elevated intraocular pressure (IOP) is no longer part of the definition of glaucoma it remains the sole proven modifiable risk factor for the onset and progression of glaucoma.
IOP is known to vary with the time of day as well as with daily activities. The importance of the nycthemeral IOP pattern for successful management of glaucoma has been well documented, especially for patients who experience visual loss despite apparently normal and/or controlled IOP during office hours.
Read more
The current way of assessing nycthemeral IOP fluctuation is to perform repeated discrete tonometry measurements, once per hour in the best cases. Since its development in the 50s, Goldmann applanation tonometry (GAT) has remained the gold standard method for measuring IOP, despite its limitations. However, tonometry may be an imperfect method for measuring changes in IOP because it allows only snapshot and non-continuous measurements, it is not physiologic and disturbs the sleep architecture.
There have been many efforts in the past decades to search for an ambulatory and frequent method to monitor IOP for 24 hours. In this context, Sensimed AG has recently developed a sensing contact lens-based device intended to measure IOP over 24 hours, the Goldfish (GF).
First-in-man data obtained with this device showed agreements between IOP measured by GF and values obtained by standard tonometry in the same eye, comparable to literature results for routinely used tonometry devices. However, this pilot study included 9 subjects only with improvable safety, tolerability and efficacy profiles.
The main goal of this study is to assess IOP measurements with the GF and compare the values with those obtained by standard tonometry in patients with open angle glaucoma (OAG) and ocular hypertension (OHT).
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- Goldfish (GF)
- 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.
Goldfish (GF)Device
The GF lens (SCL) will be place on participant's eye for a 24h IOP recording session
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | All patients will be follow the same procedures and be placed the investigational device Receives: Device: Goldfish (GF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
GF IOP measurement as compared to IOP
Differences between GF IOP measurements at the recording start/end and the values obtained by GAT before/after GF SCL placement/removal, in the same eye
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 posted18 Jul 2019
- Study start1 Oct 2025
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sensimed AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kaweh Mansouri, Pr, Principal investigator, Swiss Glaucoma Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024293
- Sponsor's protocol ID
- GF-1801-S
- Status last verified
- Apr 2026
- First submitted
- 16 Jul 2019
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single Center Open Label Study Assessing Intraocular Pressure Measurements Using a Novel Sensing Contact Lens-based Device as Compared to Standard Tonometry, in Open Angle Glaucoma and Ocular Hypertensive Patients
- ClinicalTrials.gov ID
- NCT04024293
- Acronym / sponsor ID
- GF-1801-S
- Conditions
- Glaucoma, Ocular Hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Sensimed AGIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 18 Jul 2019 (actual)
- 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.
While elevated intraocular pressure (IOP) is no longer part of the definition of glaucoma it remains the sole proven modifiable risk factor for the onset and progression of glaucoma.
IOP is known to vary with the time of day as well as with daily activities. The importance of the nycthemeral IOP pattern for successful management of glaucoma has been well documented, especially for patients who experience visual loss despite apparently normal and/or controlled IOP during office hours.
The current way of assessing nycthemeral IOP fluctuation is to perform repeated discrete tonometry measurements, once per hour in the best cases. Since its development in the 50s, Goldmann applanation tonometry (GAT) has remained the gold standard method for measuring IOP, despite its limitations. However, tonometry may be an imperfect method for measuring changes in IOP because it allows only snapshot and non-continuous measurements, it is not physiologic and disturbs the sleep architecture.
There have been many efforts in the past decades to search for an ambulatory and frequent method to monitor IOP for 24 hours. In this context, Sensimed AG has recently developed a sensing contact lens-based device intended to measure IOP over 24 hours, the Goldfish (GF).
First-in-man data obtained with this device showed agreements between IOP measured by GF and values obtained by standard tonometry in the same eye, comparable to literature results for routinely used tonometry devices. However, this pilot study included 9 subjects only with improvable safety, tolerability and efficacy profiles.
The main goal of this study is to assess IOP measurements with the GF and compare the values with those obtained by standard tonometry in patients with open angle glaucoma (OAG) and ocular hypertension (OHT).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Device: Goldfish (GF)All patients will be follow the same procedures and be placed the investigational device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed Consent
- A clinical diagnosis of primary open angle glaucoma (POAG), including normal tension glaucoma (NTG), for OAG patients
- A clinical diagnosis of OHT, for OHT patients
- For all patients:
- Open angles on gonioscopy Aged ≥ 18 years, either gender Both central corneal radii (CCR) between 7.3mm (46.23D) and 8.05mm (41.93D), with a maximum difference of 2D between the 2 radii in the study eye Central corneal thickness (CCT) between 490µm and 600µm in the study eye
Key exclusion criteria (15 listed)
- Ocular pathology (other than glaucoma or OHT)
- Previous glaucoma, cataract or refractive laser/surgery
- Corneal or conjunctival abnormality, precluding contact lens adaptation
- Insufficiency of lacrimal secretion
- Subjects with allergy to corneal anesthetic
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 |
|---|---|---|
| Goldfish (GF)The GF lens (SCL) will be place on participant's eye for a 24h IOP recording session | Device | All participants |
Primary outcome
GF IOP measurement as compared to IOP
Time frame: 24 hours
Differences between GF IOP measurements at the recording start/end and the values obtained by GAT before/after GF SCL placement/removal, in the same eye
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
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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.
Kaweh Mansouri, Pr principal investigator
Swiss Glaucoma Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goldfish (GF) 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 15 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: looking for participants now, as of the sponsor's last update on 30 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaweh Mansouri, Pr (+41 21 619 36 02, kwmansouri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GF IOP measurement as compared to IOP (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 30 Apr 2026.