Smart Soft Contact Lenses for Monitoring Glaucoma

NCT07224542 | Enrolling By Invitation FDA Device

• 2 other identifiers: IU-24139R01EY034901
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glaucoma

Keywords

glaucoma; contact lens; sensor; eye pressure; IOP; optometry; ophthalmology

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Safety Outcome - Ocular Health

  Phase 1: Day 1 Phase 2: Days 1, 2, and 3 Phase 3: Days 1, 2, and 3

• Safety Outcome - Visual Acuity

  Phase 1: Day 1 Phase 2: Days 1, 2, and 3 Phase 3: Days 1, 2, and 3

• Safety Outcome - Octopus Kinetic Visual Field

  Phase 1: Day 1

Study Arms (1)

Sensor Experimental Arm

EXPERIMENTAL

Followed with device and comparator

Device: Bare Contact Lens; Device: Clinical IOP Measure; Device: Experimental Contact Lens Sensor

Interventions

Bare Contact Lens DEVICE

Commercially available contact lens without a sensor

Sensor Experimental Arm

Clinical IOP Measure DEVICE

clinical IOP

Also known as: iCare, Goldmann

Sensor Experimental Arm

Experimental Contact Lens Sensor DEVICE

Sensor contact lens being studied

Sensor Experimental Arm

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + years of age
• Able to wear soft contact lenses
• Previously diagnosed, currently pharmaceutically treated Primary Open Angle Glaucoma (POAG)
• + years of age
• Able to wear soft contact lenses
• Without glaucomatous disease

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• National Eye Institute (NEI): collaborator
• Purdue University: collaborator

Study Sites (1)

Indiana University - Clinical Optics Research Lab

Bloomington, Indiana, 47405, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Pete S Kollbaum

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean

Study Record Dates

• First Submitted: October 17, 2025
• First Posted: November 4, 2025
• Study Start: October 19, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: November 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: October 19, 2025 - September 20, 2028
• 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.

Locations

US (1)