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| ID | Type | Description | Link |
|---|---|---|---|
| R01EY034901 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
| Purdue University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sensor Experimental Arm | Experimental | Followed with device and comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bare Contact Lens | Device | Commercially available contact lens without a sensor |
| |
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Glaucomatous Arm Inclusion Criteria
Non-Glaucomatous (Healthy Older Adults) Arm Inclusion Criteria
Exclusion Criteria for all arms:
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| Name | Affiliation | Role |
|---|---|---|
| Pete S Kollbaum | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University - Clinical Optics Research Lab | Bloomington | Indiana | 47405 | United States |
All de-identified IPD will be shared.
October 19, 2025 - September 20, 2028
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.
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| Clinical IOP Measure |
| Device |
clinical IOP |
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| Experimental Contact Lens Sensor | Device | Sensor contact lens being studied |
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| Phase 1: Day 1 Phase 2: Days 1, 2, and 3 Phase 3: Days 1, 2, and 3 |
| 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 |