NCT06689696

24-hour Wear Performance and Safety Study of Smartlens miLens Contact Lens for IOP Monitoring

Pivotal Clinical Study to Evaluate the Smartlens miLens Measurement Performance and Safety Over a 24-hour Wear Period

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 86 (actual)
• Sponsor: Smartlens, Inc. · Industry
• Sex: All
• Age: 22 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to learn if a new contact lens device can record patterns in eye pressure for 24 hours in adults with glaucoma and in healthy participants. The main questions it aims to answer are: * Is the contact lens device able to detect patterns in eye pressure that happens naturally between nighttime and daytime? * Are the contact lens recording patterns similar when repeated one week later? * What eye problems do participants have when wearing contact lens for up to 24 hours? Researchers will compare if the recordings detected by the contact lens over 24 hours are similar to the patterns measured by an eye pressure measuring instrument used in a doctor's office. Participants will * Wear contact lens in one eye for up to 24 hours * Take recordings in that eye with smartphone camera every 15 minutes when awake * For those participants who are able to stay overnight at a hotel for the trial, researchers will measure the eye pressure in the other eye every 1 to 2 hours when awake with an eye pressure measuring instrument.

Detailed description

This study will enroll healthy participants and those with primary open-angle glaucoma or ocular hypertension from a minimum of two and up to 10 research sites in US. All participants will be informed about the study and its potential risks and required to provide written informed consent prior to undergoing study-related procedures. Participants will be screened for eligibility. The study will be conducted in a 24-hour session in eligible subjects, preferably at a hotel or similar location that allows overnight stay. For subjects who complete the first session at a hotel and are able to return in a week, the study will be repeated in another 24-hour session. At the beginning of the 24-hour session, the study staff will place the miLens in the study eye. The study eye is designated as the eye with higher intraocular pressure (IOP) or randomly selected if IOP is equal. Participants will be asked to capture miLens measurements using smartphone camera. The miLens smartphone app will auto-adjust zoom and capture image, which will be automatically sent to the cloud-based image processing software. The participants will be asked to capture miLens images every 15 minutes over 24 hours, except during sleep time between 10:30 pm and 5:30 am. The study staff will also measure IOP in the other eye using a tonometer every 1-2 hours. In addition, participants will be asked to rate comfort on a numerical scale to assess tolerability to lens wear. Safety is assessed by biomicroscopy examination and by measuring vision and refraction before and after the session. The 24-hour session is repeated after 6-8 days, starting at around the same time as the first session, in the same study eye.

Conditions

• Glaucoma
• GLAUCOMA 1, OPEN ANGLE, D (Disorder)
• Ocular Hypertension
• Ocular Hypertension (OH)
• Ocular Hypertension Glaucoma
• IOP
• Intraocular Pressure
• Glaucoma Open-Angle
• Glaucoma and Ocular Hypertension
• Glaucoma Patients and Healthy Controls
• Normal Tension Glaucoma (NTG)

Interventions

Type	Name	Description
DEVICE	miLens system	The miLens system consists of the miLens contact lens made of soft, biocompatible materials, the miLens imaging system, and miLens analysis software.

Timeline

• Start date: 2025-02-19
• Primary completion: 2025-08-01
• Completion: 2026-01-06
• First posted: 2024-11-14
• Last updated: 2026-04-01

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study