NCT07224542

Smart Soft Contact Lenses for Monitoring Glaucoma

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Glaucoma

Interventions

Type	Name	Description
DEVICE	Bare Contact Lens	Commercially available contact lens without a sensor
DEVICE	Clinical IOP Measure	clinical IOP
DEVICE	Experimental Contact Lens Sensor	Sensor contact lens being studied

Timeline

• Start date: 2025-10-19
• Primary completion: 2028-09-30
• Completion: 2028-09-30
• First posted: 2025-11-04
• Last updated: 2025-11-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study