Smart Soft Contact Lenses for Monitoring Glaucoma

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: Enrolling by invitation
• Conditions: Glaucoma
• Intervention / Treatment: Device: Bare Contact Lens; Device: Clinical IOP Measure; Device: Experimental Contact Lens Sensor

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: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sensor Experimental Arm; Followed with device and comparator	Device: Bare Contact Lens; Commercially available contact lens without a sensor; Device: Clinical IOP Measure; clinical IOP; Other Names: iCare; Goldmann; Device: Experimental Contact Lens Sensor; Sensor contact lens being studied

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Phase 2: 1 hour on 3 days Phase 3: Up to 14 hours on 3 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Outcome - Visual Acuity	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	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	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	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

• Sponsor: Indiana University
• Collaborators: National Eye Institute (NEI); Purdue University
• Investigators: Principal Investigator: Pete S Kollbaum, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: October 17, 2025
• First Submitted That Met QC Criteria: October 31, 2025
• First Posted (Estimated): November 4, 2025

Study Record Updates

• Last Update Posted (Estimated): November 5, 2025
• Last Update Submitted That Met QC Criteria: November 3, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: glaucoma; IOP; contact lens; ophthalmology; sensor; eye pressure; optometry
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID 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