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NCT07224542

Smart Soft Contact Lenses for Monitoring Glaucoma

Enrolling by Invitation
NAAges 22+Interventional
Indiana University
~120 participants
Updated 2025-11-05 on ClinicalTrials.gov
What's tested:Bare Contact LensClinical IOP MeasureExperimental Contact Lens Sensor

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Goldmann Applanation Intraocular Pressure
Measured over Phase 2: 1 hour on 3 days Phase 3: Up to 14 hours on 3 days
+3 more outcomes measured

Conditions

Glaucoma

Explore related trials

Healthy VolunteersPrimary Open Angle Glaucoma

Where it's being run

1 sites across 1 states
Indiana1

Study leadership

  • Pete S Kollbaum · PRINCIPAL_INVESTIGATOR · Indiana University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Goldmann Applanation Intraocular PressurePhase 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 PressurePhase 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 comfortPhase 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 FitPhase 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.