Smart Soft Contact Lenses for Monitoring Glaucoma

NCT ID: NCT07224542

Last Updated: 2025-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-19

Study Completion Date

2028-09-30

Brief Summary

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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

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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

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Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Sensor Experimental Arm

Followed with device and comparator

Group Type EXPERIMENTAL

Bare Contact Lens

Intervention Type DEVICE

Commercially available contact lens without a sensor

Clinical IOP Measure

Intervention Type DEVICE

clinical IOP

Experimental Contact Lens Sensor

Intervention Type DEVICE

Sensor contact lens being studied

Interventions

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Bare Contact Lens

Commercially available contact lens without a sensor

Intervention Type DEVICE

Clinical IOP Measure

clinical IOP

Intervention Type DEVICE

Experimental Contact Lens Sensor

Sensor contact lens being studied

Intervention Type DEVICE

Other Intervention Names

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iCare Goldmann

Eligibility Criteria

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Inclusion Criteria

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


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

Exclusion Criteria

* 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
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Eye Institute (NEI)

NIH

Sponsor Role collaborator

Purdue University

OTHER

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Pete Kollbaum, OD, PhD

Associate Dean

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pete S Kollbaum

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

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Indiana University - Clinical Optics Research Lab

Bloomington, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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R01EY034901

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IU-24139

Identifier Type: -

Identifier Source: org_study_id

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