An interventional study of Bare Contact Lens and Experimental Smart Contact Lens in Glaucoma, sponsored by Indiana University. Enrolling by invitation at 1 site in United States. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Indiana University · Not applicable, Interventional, and Other
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.
1,419 studies on the registry are indexed under Glaucoma; 223 are open to participants now.
This study's planned enrollment of 120 is above the median of 61 across 964 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →Indiana University is the lead sponsor of 986 studies on the registry; 198 are open to participants now.
Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Glaucomatous Arm Inclusion Criteria
Non-Glaucomatous (Healthy Older Adults) Arm Inclusion Criteria
Exclusion Criteria for all arms:
During the study visits, participants will undergo visual and ocular assessments and be asked to rate the comfort of their eyes. The investigational smart contact will be worn in one eye and compared to no lens in the other eye, a bare lens in the other eye, and a comparator smart lens in the other eye.
Device: Bare Contact Lens · Device: Experimental Smart Contact Lens · Device: Commercially available smart contact lens
During the study visits, participants will undergo visual and ocular assessments and be asked to rate the comfort of their eyes. The investigational smart contact will be worn in one eye and compared to no lens in the other eye, a bare lens in the other eye, and a comparator smart lens in the other eye.
Device: Bare Contact Lens · Device: Experimental Smart Contact Lens · Device: Commercially available smart contact lens
Commercially available contact lens without a sensor
Sensor contact lens being studied
The Triggerfish ocular monitoring system includes a disposable silicone soft contact lens with an embedded sensor, a wireless antenna, and a portable recorder.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Phase 2: 1 hour on 3 days Phase 3: Up to 14 hours on 3 days
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Phase 1: Day 1 Phase 2: Days 1, 2, and 3 Phase 3: Days 1, 2, and 3
Plan to share: Yes — All de-identified IPD will be shared.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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.
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Sep 2028, 35 months after the start.
Of 229 non-industry interventional studies with no phase under Glaucoma, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 55. This study's planned 35 months is above that.
Counting every sponsor, half of 287 studies reached it within 30 months; a quarter within 12 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
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