Smart Soft Contact Lenses for Monitoring Glaucoma

August 21, 2026 updated by: Pete Kollbaum, OD, PhD, Indiana University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Bloomington, Indiana, United States, 47405
        • Indiana University - Clinical Optics Research Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Glaucomatous Arm Inclusion Criteria

  • 22+ years of age
  • Able to wear soft contact lenses
  • Previously diagnosed, currently pharmaceutically treated Primary Open Angle Glaucoma (POAG)

Non-Glaucomatous (Healthy Older Adults) Arm Inclusion Criteria

  • 22+ years of age
  • Able to wear soft contact lenses
  • Without glaucomatous disease

Exclusion Criteria for all arms:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Participants without Glaucoma
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.
Device: Bare Contact Lens
Commercially available contact lens without a sensor
Device: Experimental Smart Contact Lens
Sensor contact lens being studied
Device: Commercially available smart contact lens
The Triggerfish ocular monitoring system includes a disposable silicone soft contact lens with an embedded sensor, a wireless antenna, and a portable recorder.
Other: Participants with Glaucoma
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.
Device: Bare Contact Lens
Commercially available contact lens without a sensor
Device: Experimental Smart Contact Lens
Sensor contact lens being studied
Device: Commercially available smart contact lens
The Triggerfish ocular monitoring system includes a disposable silicone soft contact lens with an embedded sensor, a wireless antenna, and a portable recorder.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Phase 2: 1 hour on 3 days Phase 3: Up to 14 hours on 3 days
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.
Phase 2: 1 hour on 3 days Phase 3: Up to 14 hours on 3 days
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.
Phase 2: 1 hour on 3 days Phase 3: Up to 14 hours on 3 days
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.
Phase 2: 1 hour on 3 days Phase 3: Up to 14 hours on 3 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety Outcome - Visual Acuity
Time Frame: Phase 1: Day 1 Phase 2: Days 1, 2, and 3 Phase 3: Days 1, 2, and 3
LogMAR visual acuity will be measured using ETDRS charts. A 0.2 change in visual acuity is considered a clinically significant change.
Phase 1: Day 1 Phase 2: Days 1, 2, and 3 Phase 3: Days 1, 2, and 3
Safety Outcome - Octopus Kinetic Visual Field
Time Frame: Phase 1: Day 1
Visual field extent (horizontal and vertical) will be measured with a kinetic visual field (e.g. Octopus Visual field). A 30% decrease in rate of visual field progression can be reliably projected to have a significant effect on health-related quality of life.
Phase 1: Day 1
Safety Outcome - Corneal Thickness/Swelling
Time Frame: Phase 1: Day 1 Phase 2: Days 1, 2, and 3 Phase 3: Days 1, 2, and 3
Corneal thickness/swelling will be measured using anterior segment ocular coherence tomography (OCT). Corneal swelling should be <8% following lens wear.
Phase 1: Day 1 Phase 2: Days 1, 2, and 3 Phase 3: Days 1, 2, and 3
Safety Outcome - Ocular Health
Time Frame: Phase 1: Day 1 Phase 2: Days 1, 2, and 3 Phase 3: Days 1, 2, and 3
Investigator rated ocular health (hyperemia, conjunctival indentation, corneal staining) (0-4 Efron grading scale, where a rating of 0 represents an optimal outcome). Ocular health gradings following device wear will be compared pre-device use and post-device use and comparator bare soft contact lens use. A change in ocular health of 2 on the grading scale is considered clinically significant.
Phase 1: Day 1 Phase 2: Days 1, 2, and 3 Phase 3: Days 1, 2, and 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indiana University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Eye Institute (NEI)
Purdue University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pete S Kollbaum, Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 19, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IU-24139
  • R01EY034901 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All de-identified IPD will be shared.

IPD Sharing Time Frame

October 19, 2025 - September 20, 2028

IPD Sharing Access Criteria

Study team members at Purdue University will be able to access all de-identified data collected during the study. This data will be shared via a secure electronic transfer.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings