Glaucoma, Open-AngleNCT03689088
Sensing Contact Lens-based Device for 24-hour Monitoring of Intraocular Pressure
A study testing Goldfish and Tonometry in people with Glaucoma, Open-Angle and Healthy, run by Sensimed AG at 1 site in Poland.
Trial summary
Glaucoma is characterized by irreversible vision loss through the progressive death of optic nerve fibers unless timely diagnosis and adequate treatment are provided. Medical therapy is aimed at lowering intraocular pressure (IOP) below a clinically determined target level in order to prevent or slow glaucoma… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Open-Angle, Healthy
- What is being tested?
- Goldfish and Tonometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 sitePoland
- Study dates
- 22 May 2018to 6 Sep 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For Open Angle Glaucoma (OAG) subjects, a clinical diagnosis of primary OAG, including normal tension glaucoma (NTG) all known untreated IOP measurements < 22 mmHg using Goldmann Applanation Tonometry (GAT) for NTG no IOP-lowering treatment; otherwise, a 4-week wash-out period prior to the recording
- For healthy subjects, no structural defects, normal visual fields, IOP ≤ 21 mmHg and open angles on gonioscopy
- Aged ≥ 18 years, either gender
- Body Mass Index ≤ 30 kg/m2
- Central Corneal Radius (flat meridian) between 7.5 mm (45 D) and 7.9 mm (42.75 D)
- Central Corneal Thickness between 500 microns and 600 microns
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- Difference in IOP absolute value between eyes within 2.5 mmHg at screening in sitting position
- Same direction of IOP variation (positive or negative) for the 2 eyes when moving from sitting to supine positions at screening
- Spherical refraction within ±6.00 diopters and cylinder refraction within ±3.00 diopters
- Having given written informed consent, prior to any investigational procedures
Who cannot join
- Ocular pathology (other than glaucoma for glaucoma subjects)
- Previous glaucoma, cataract or refractive surgery
- Corneal or conjunctival abnormality, precluding contact lens adaptation
- Severe dry eye syndrome
- Subjects with allergy to corneal anesthetic
- Subjects with contraindications for silicone CL wear
Show all 9Show fewer
- Subjects with contraindications for Water Drinking Test (WDT) (eg., heart, renal problems)
- Subjects unable or unwilling to comply with the study procedures
- Participation in other interventional clinical research within the last 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Pilot Study Investigating the Use of a Sensing Contact Lens-based Device for 24-hour Monitoring of Intraocular Pressure in Healthy Subjects and Patients With Open Angle Glaucoma
Glaucoma is characterized by irreversible vision loss through the progressive death of optic nerve fibers unless timely diagnosis and adequate treatment are provided. Medical therapy is aimed at lowering intraocular pressure (IOP) below a clinically determined target level in order to prevent or slow glaucoma progression. IOP is known to vary with the time of day as well as with daily activities.
The current way of assessing nycthemeral IOP fluctuation is to perform repeated discrete tonometry measurements, allowing only snapshot and non-continuous measurements once per hour in the best cases. The procedure is cumbersome, expensive, inconvenient (disturbed sleep cycle as patient is awoken for nocturnal/sleep period measurements) and may not detect crucial IOP values in time.
Sensimed AG has developed a new contact lens (CL)-based device intended to continuously measure IOP over 24 hours. The objective of this study is to investigate the use of device for 24-hour IOP monitoring in healthy subjects and glaucoma patients.
- Conditions
- Glaucoma, Open-Angle, Healthy
- Being tested
- Goldfish, Tonometry
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GoldfishDevice
Goldfish will be placed in the eye for 24h monitoring
TonometryDevice
Fellow eye will be measured by tonometry
| Study group | Role | What they receive |
|---|---|---|
| Investigational device (Goldfish) | Experimental | IOP will be monitored for 24 h in the Goldfish eye Receives: Device: Goldfish |
| Tonometry | Active comparator | IOP will be acquired by standard tonometry at specific times in the the fellow eye Receives: Device: Tonometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in IOP assessed by Goldfish following known physiological and induced changes in IOP
IOP will be measured using tonometry in the fellow eye and compared to IOP measured in the Goldfish eye with the Goldfish device
Measured: 24 hours
Secondary outcomes (5)
Percentage of subjects completing 24-hour session with Goldfish
Percentage of subject completing the session will be calculated at the end of the study
Measured: 24 hours
Wearing discomfort of Goldfish based on visual analogue scale
Tolerability of the Goldfish lens will be subjectively evaluated before and after GF wear using a visual analogue scale from 0 (no discomfort) to 100 (severe discomfort) mm
Measured: 24 hours
Evaluation of Goldfish technical performance based on the percentage of valid Goldfish measurements
Percentage of valid measurement will be calculated at the end of each monitoring session
Measured: 24 hours
Correlation between IOP and ocular pulse amplitude (OPA) assessed by Goldfish in the Goldfish eye and IOP and OPA measured by tonometry in the fellow eye
OPA will be extracted from the Goldfish signal in the Goldfish eye and measured by tonometry in the fellow eye. Both IOP and OPA measurement will be compared between fellow eyes
Measured: 24 hours
Relationship between Goldfish IOP and blood pressure (BP) measurements over 24 hours
IOP signal acquired with Goldfish will be compared to BP signal assessed with a BP holter
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 posted28 Sep 2018
- Study start22 May 2018
- Primary completion4 Jul 2018
- Study completion6 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sensimed AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Wasilewicz, MD, Principal investigator, [W]-Eye Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689088
- Sponsor's protocol ID
- GF-1703
- Status last verified
- Nov 2018
- First submitted
- 21 Sep 2018
- Last updated
- 4 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Pilot Study Investigating the Use of a Sensing Contact Lens-based Device for 24-hour Monitoring of Intraocular Pressure in Healthy Subjects and Patients With Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT03689088
- Acronym / sponsor ID
- GF-1703
- Conditions
- Glaucoma, Open-Angle, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Sensimed AGIndustry (pharma, biotech, devices)
- Study start
- 22 May 2018 (actual)
- Primary completion
- 4 Jul 2018 (actual)
- Study completion
- 6 Sep 2018 (actual)
- First posted
- 28 Sep 2018 (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.
Glaucoma is characterized by irreversible vision loss through the progressive death of optic nerve fibers unless timely diagnosis and adequate treatment are provided. Medical therapy is aimed at lowering intraocular pressure (IOP) below a clinically determined target level in order to prevent or slow glaucoma progression. IOP is known to vary with the time of day as well as with daily activities.
The current way of assessing nycthemeral IOP fluctuation is to perform repeated discrete tonometry measurements, allowing only snapshot and non-continuous measurements once per hour in the best cases. The procedure is cumbersome, expensive, inconvenient (disturbed sleep cycle as patient is awoken for nocturnal/sleep period measurements) and may not detect crucial IOP values in time.
Sensimed AG has developed a new contact lens (CL)-based device intended to continuously measure IOP over 24 hours. The objective of this study is to investigate the use of device for 24-hour IOP monitoring in healthy subjects and glaucoma patients.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational device (Goldfish) | Experimental | Device: GoldfishIOP will be monitored for 24 h in the Goldfish eye |
| Tonometry | Active comparator | Device: TonometryIOP will be acquired by standard tonometry at specific times in the the fellow eye |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- For Open Angle Glaucoma (OAG) subjects, a clinical diagnosis of primary OAG, including normal tension glaucoma (NTG) all known untreated IOP measurements < 22 mmHg using Goldmann Applanation Tonometry (GAT) for NTG no IOP-lowering treatment; otherwise, a 4-week wash-out period prior to the recording
- For healthy subjects, no structural defects, normal visual fields, IOP ≤ 21 mmHg and open angles on gonioscopy
- Aged ≥ 18 years, either gender
- Body Mass Index ≤ 30 kg/m2
- Central Corneal Radius (flat meridian) between 7.5 mm (45 D) and 7.9 mm (42.75 D)
Key exclusion criteria (9 listed)
- Ocular pathology (other than glaucoma for glaucoma subjects)
- Previous glaucoma, cataract or refractive surgery
- Corneal or conjunctival abnormality, precluding contact lens adaptation
- Severe dry eye syndrome
- 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 |
|---|---|---|
| GoldfishGoldfish will be placed in the eye for 24h monitoring | Device | Investigational device (Goldfish) |
| TonometryFellow eye will be measured by tonometry | Device | Tonometry |
Primary outcome
Changes in IOP assessed by Goldfish following known physiological and induced changes in IOP
Time frame: 24 hours
IOP will be measured using tonometry in the fellow eye and compared to IOP measured in the Goldfish eye with the Goldfish device
5 secondary outcomes
Percentage of subjects completing 24-hour session with Goldfish
Time frame: 24 hours
Wearing discomfort of Goldfish based on visual analogue scale
Time frame: 24 hours
Evaluation of Goldfish technical performance based on the percentage of valid Goldfish measurements
Time frame: 24 hours
Correlation between IOP and ocular pulse amplitude (OPA) assessed by Goldfish in the Goldfish eye and IOP and OPA measured by tonometry in the fellow eye
Time frame: 24 hours
Relationship between Goldfish IOP and blood pressure (BP) measurements over 24 hours
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 Dec 2018.
- Individual participant dataSharing planned: No
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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.
Robert Wasilewicz, MD principal investigator
[W]-Eye Clinic
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 and Tonometry in people with Glaucoma, Open-Angle and Healthy, run by Sensimed AG at 1 site in Poland.
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 10 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 Dec 2018. 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 Poland. 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?
Changes in IOP assessed by Goldfish following known physiological and induced changes in 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 4 Dec 2018; AzTrials last refreshed its copy on 7 Nov 2026.