GlaucomaNCT07224542
Smart Soft Contact Lenses for Monitoring Glaucoma
A study testing Bare Contact Lens, Experimental Smart Contact Lens and Commercially available smart contact lens in people with Glaucoma, run by Indiana University at 1 site in United States.
Trial summary
This study is exploring the effectiveness and safety of soft contact lenses with embedded sensors, called smart contact lenses. Smart contact lenses are used to measure the pressure inside the eye. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Bare Contact Lens, Experimental Smart Contact Lens and Commercially available smart contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2025to 30 Sep 2028
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Unable to complete the study procedures
- Ocular disease other than glaucoma (if applicable)
- Significant acute or chronic medical, neurologic, or other illness in the patient that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study and/or is contradicted for soft contact lens or sensor lens use
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Indiana University - Clinical Optics Research Lab
Bloomington, Indiana, 47405
About this study
Official title: Smart Soft Contact Lenses for Continuous 24-hour Monitoring of Intraocular Pressure in Glaucoma Care
This study is exploring the effectiveness and safety of soft contact lenses with embedded sensors, called smart contact lenses. Smart contact lenses are used to measure the pressure inside the eye.
Read the detailed description
Subjects first present for a single qualification visit (phase 1), then present for up to 3 short-term (~1 hour) in-clinic visits (phase 2), and finally have visits prior to and following a full day (phase 3). Efficacy outcomes of the smart contact lens are compared to standard clinical measures of eye pressure. Safety outcomes of the smart contact lens are compared to those of traditional soft contact lenses.
- Conditions
- Glaucoma
- Being tested
- Bare Contact Lens, Experimental Smart Contact Lens, Commercially available smart contact lens
- Keywords
- glaucoma, contact lens, sensor, eye pressure, IOP, optometry, ophthalmology
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bare Contact LensDevice
Commercially available contact lens without a sensor
Experimental Smart Contact LensDevice
Sensor contact lens being studied
Commercially available smart contact lensDevice
The Triggerfish ocular monitoring system includes a disposable silicone soft contact lens with an embedded sensor, a wireless antenna, and a portable recorder.
| Study group | Role | What they receive |
|---|---|---|
| Participants without Glaucoma | Other | During the study visits, participants will undergo visual and ocular assessments and be asked to rate the comfort of their eyes. The investigational smart contact will be worn in one eye and compared to no lens in the other eye, a bare lens in the other eye, and a comparator smart lens in the other eye. Receives: Device: Bare Contact Lens; Device: Experimental Smart Contact Lens; Device: Commercially available smart contact lens |
| Participants with Glaucoma | Other | During the study visits, participants will undergo visual and ocular assessments and be asked to rate the comfort of their eyes. The investigational smart contact will be worn in one eye and compared to no lens in the other eye, a bare lens in the other eye, and a comparator smart lens in the other eye. Receives: Device: Bare Contact Lens; Device: Experimental Smart Contact Lens; Device: Commercially available smart contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goldmann Applanation Intraocular Pressure
The IOP of participants will be measured with the Goldmann applanation tonometry (GAT) prior to and following device use, and in the contralateral eye during device use. A >2 mmHg difference in is considered clinically significantly different.
Measured: Phase 2: 1 hour on 3 days Phase 3: Up to 14 hours on 3 days
I-Care Tonometry Intraocular Pressure
The I-Care (I-Care, Inc.) tonometry will also be evaluated during contralateral eye device use. A >2 mmHg difference in is considered clinically significantly different.
Measured: Phase 2: 1 hour on 3 days Phase 3: Up to 14 hours on 3 days
Lens comfort
Participant-reported comfort will be assessed using a simple 100-point numeric scale where a rating of '100' represents extremely uncomfortable/intolerable and a rating of '1' perfectly comfortable/not noticeable at all. Comfort assessments will occur prior to, during, and following all device use to allow comparisons to typical or comparator devices. A 7-point difference in ratings is considered clinically significantly different.
Measured: Phase 2: 1 hour on 3 days Phase 3: Up to 14 hours on 3 days
Lens Fit
Lens fit will be measured with slit lamp during lens wear and graded using the Cornea and Contact Lens Research Unit (CCLRU) grading scale, which ranges from 0 to 4 with a rating of 0 representing an optimal outcome. A difference of 1.0 grading unit will be considered clinically significant.
Measured: Phase 2: 1 hour on 3 days Phase 3: Up to 14 hours on 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2025
- Study start19 Oct 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (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.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI), Purdue University
- Responsible party
- Principal investigator, Pete Kollbaum, OD, PhD, Indiana University
- Investigators
- Pete S Kollbaum, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07224542
- Sponsor's protocol ID
- IU-24139
- Other IDs
- R01EY034901
- Status last verified
- Aug 2026
- First submitted
- 17 Oct 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All de-identified IPD will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Soft Contact Lenses for Continuous 24-hour Monitoring of Intraocular Pressure in Glaucoma Care
- ClinicalTrials.gov ID
- NCT07224542
- Acronym / sponsor ID
- IU-24139
- Conditions
- Glaucoma
- Keywords
- glaucoma, contact lens, sensor, eye pressure, IOP, optometry, ophthalmology
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI), Purdue University
- Study start
- 19 Oct 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 4 Nov 2025 (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.
This study is exploring the effectiveness and safety of soft contact lenses with embedded sensors, called smart contact lenses. Smart contact lenses are used to measure the pressure inside the eye.
Detailed description
Subjects first present for a single qualification visit (phase 1), then present for up to 3 short-term (~1 hour) in-clinic visits (phase 2), and finally have visits prior to and following a full day (phase 3). Efficacy outcomes of the smart contact lens are compared to standard clinical measures of eye pressure. Safety outcomes of the smart contact lens are compared to those of traditional soft contact lenses.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants without Glaucoma | Other | Device: Bare Contact Lens, Device: Experimental Smart Contact Lens, Device: Commercially available smart contact lensDuring the study visits, participants will undergo visual and ocular assessments and be asked to rate the comfort of their eyes. The investigational smart contact will be worn in one eye and compared to no lens in the other eye, a bare lens in the other eye, and a comparator smart lens in the other eye. |
| Participants with Glaucoma | Other | Device: Bare Contact Lens, Device: Experimental Smart Contact Lens, Device: Commercially available smart contact lensDuring the study visits, participants will undergo visual and ocular assessments and be asked to rate the comfort of their eyes. The investigational smart contact will be worn in one eye and compared to no lens in the other eye, a bare lens in the other eye, and a comparator smart lens in the other eye. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Unable to complete the study procedures
- Ocular disease other than glaucoma (if applicable)
- Significant acute or chronic medical, neurologic, or other illness in the patient that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study and/or is contradicted for soft contact lens or sensor lens use
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 |
|---|---|---|
| Bare Contact LensCommercially available contact lens without a sensor | Device | Participants with Glaucoma, Participants without Glaucoma |
| Experimental Smart Contact LensSensor contact lens being studied | Device | Participants with Glaucoma, Participants without Glaucoma |
| Commercially available smart contact lensThe Triggerfish ocular monitoring system includes a disposable silicone soft contact lens with an embedded sensor, a wireless antenna, and a portable recorder. | Device | Participants with Glaucoma, Participants without Glaucoma |
Primary outcome
Goldmann Applanation Intraocular Pressure
Time frame: Phase 2: 1 hour on 3 days Phase 3: Up to 14 hours on 3 days
The IOP of participants will be measured with the Goldmann applanation tonometry (GAT) prior to and following device use, and in the contralateral eye during device use. A >2 mmHg difference in is considered clinically significantly different.
I-Care Tonometry Intraocular Pressure
Time frame: Phase 2: 1 hour on 3 days Phase 3: Up to 14 hours on 3 days
The I-Care (I-Care, Inc.) tonometry will also be evaluated during contralateral eye device use. A >2 mmHg difference in is considered clinically significantly different.
Lens comfort
Time frame: Phase 2: 1 hour on 3 days Phase 3: Up to 14 hours on 3 days
Participant-reported comfort will be assessed using a simple 100-point numeric scale where a rating of '100' represents extremely uncomfortable/intolerable and a rating of '1' perfectly comfortable/not noticeable at all. Comfort assessments will occur prior to, during, and following all device use to allow comparisons to typical or comparator devices. A 7-point difference in ratings is considered clinically significantly different.
Lens Fit
Time frame: Phase 2: 1 hour on 3 days Phase 3: Up to 14 hours on 3 days
Lens fit will be measured with slit lamp during lens wear and graded using the Cornea and Contact Lens Research Unit (CCLRU) grading scale, which ranges from 0 to 4 with a rating of 0 representing an optimal outcome. A difference of 1.0 grading unit will be considered clinically significant.
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 25 Aug 2026.
- Individual participant dataSharing planned: Yes. All de-identified IPD will be shared.
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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.
Pete S Kollbaum principal investigator
Indiana 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 Bare Contact Lens, Experimental Smart Contact Lens and Commercially available smart contact lens in people with Glaucoma, run by Indiana University 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 0 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 25 Aug 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 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?
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?
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?
Goldmann Applanation Intraocular Pressure (time frame: Phase 2: 1 hour on 3 days Phase 3: Up to 14 hours on 3 days). The study lists 4 primary outcomes in all. 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 25 Aug 2026.