Smart Soft Contact Lenses for Monitoring Glaucoma
Part of paid clinical trials in Bloomington, Indiana.
- Sponsor
- Indiana University
- Study ID
- NCT07224542
- Status
- Enrolling By Invitation
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 22 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Bare Contact Lens — DEVICECommercially available contact lens without a sensor
- Experimental Smart Contact Lens — DEVICESensor contact lens being studied
- Commercially available smart contact lens — DEVICEThe Triggerfish ocular monitoring system includes a disposable silicone soft contact lens with an embedded sensor, a wireless antenna, and a portable recorder.
Study Details
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.
Key Dates
- First listed
- Nov 4, 2025
- Start date
- Oct 19, 2025
- Status verified
- Aug 2026
- Primary completion
- Sep 30, 2028
- Completion
- Sep 30, 2028
Study Design
- Enrollment
- 120 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- OTHER
Arms
- Other: Participants without GlaucomaDuring 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.
- Other: Participants with GlaucomaDuring 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.
Primary Outcome Measure
Goldmann Applanation Intraocular Pressure [ Time Frame: Phase 2: 1 hour on 3 days Phase 3: Up to 14 hours on 3 days ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Indiana University - Clinical Optics Research Lab | Bloomington | Indiana | 47405 | - |
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