RecruitingNCT06689696

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


Sponsor

Smartlens, Inc.

Enrollment

125 participants

Start Date

Feb 19, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 22 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a smart contact lens (Smartlens miLens) that continuously monitors eye pressure (intraocular pressure, or IOP) over 24 hours. High eye pressure is linked to glaucoma, and being able to track it around the clock — rather than just during clinic visits — could improve how glaucoma is managed. **You may be eligible if...** - You are between 22 and 80 years old - You have been diagnosed with open-angle glaucoma (including normal tension glaucoma) or are suspected of having glaucoma or elevated eye pressure in at least one eye **You may NOT be eligible if...** - You have had recent eye surgery or have corneal problems that prevent contact lens wear - You have active eye infections or inflammation - You are unable to tolerate a contact lens for the study duration Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEmiLens system

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


Locations(3)

Nvision Clinical Reseacrh, LLC

Fullerton, California, United States

North Bay Eye Associates, Inc.

Petaluma, California, United States

Nvision Clinical Research, LLC

Torrance, California, United States

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NCT06689696


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