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

NCT06689696 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 86

Last updated 2026-04-01

No results posted yet for this study

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.

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

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.

Sponsors & Collaborators

  • Smartlens, Inc.

    lead INDUSTRY

Eligibility

Min Age
22 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-19
Primary Completion
2025-08-01
Completion
2026-01-06
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06689696 on ClinicalTrials.gov