Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07224542

Smart Soft Contact Lenses for Monitoring Glaucoma

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University - Clinical Optics Research Lab

Bloomington, Indiana, 47405, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bare Contact Lens

Device

Commercially available contact lens without a sensor

Clinical IOP Measure

Device

clinical IOP

Other names: iCare, Goldmann

Experimental Contact Lens Sensor

Device

Sensor contact lens being studied

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Other outcomes

  1. 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.

  2. 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.

  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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • National Eye Institute (NEI)
  • Purdue University

Registry information

Official study title

Smart Soft Contact Lenses for Continuous 24-hour Monitoring of Intraocular Pressure in Glaucoma Care

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 4, 2025
Registry last updated
Nov 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.