Smart Soft Contact Lenses for Monitoring Glaucoma

Not Applicable

• Conditions: Glaucoma

• Registration Number: NCT07224542
• Lead Sponsor: Indiana University

Brief 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.

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-17
• Study Start: 2025-10-19
• Study First Submitted QC: 2025-10-31
• Last Update Submitted: 2025-10-31
• Study First Posted: 2025-11-04
• Last Update Posted: 2025-11-04
• Primary Completion: 2028-09-30
• Study Completion: 2028-09-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Goldmann Applanation Intraocular Pressure	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.
I-Care Tonometry Intraocular Pressure	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.
Lens comfort	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.
Lens Fit	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. A difference of 1.0 grading unit will be considered clinically significant.

Trial Locations

Locations (1)

Indiana University - Clinical Optics Research Lab; 🇺🇸 Bloomington, Indiana, United States