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NCT06689696 · ClinicalTrials.gov registry record
24-hour Wear Performance and Safety Study of Smartlens miLens Contact Lens for IOP Monitoring
A clinical trial of Glaucoma and Ocular Hypertension, sponsored by Smartlens.
- Recruiting
- Registry status
- 125
- Enrollment target
- 3
- Study locations
NCT06689696: Recruiting study of Glaucoma and Ocular Hypertension, sponsored by Smartlens.
NCT06689696 is a study of Glaucoma and Ocular Hypertension that is actively recruiting participants, run by Smartlens. The registered enrollment target is 125 participants, below the 909-participant average among 92 other Glaucoma trials with a reported enrollment target (86% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06689696, a study of Glaucoma and Ocular Hypertension, is actively recruiting participants, sponsored by Smartlens.
- RECRUITING
- Registry status
- 125 participants
- Enrollment target
- 3
- Study locations
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.
Primary Outcome
Positive change in miLens output (via self-operated image acquisition) from evening (the lowest of 6 pm - 7 pm / 7 pm - 8 pm / 8 pm - 9 pm / 9 pm - 10 pm) to morning (the highest of 7 am - 8 am / 8 am - 9 am / 9 am - 10 am / 10 am -11 am)
Conditions Studied
Interventions
- DEVICE miLens system
Study Locations (3)
California
- Nvision Clinical Reseacrh, LLC - Fullerton
- North Bay Eye Associates, Inc. - Petaluma
- Nvision Clinical Research, LLC - Torrance
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2025-02-19 |
| Est. Completion | 2026-02 |
What NCT06689696 shows while recruiting
NCT06689696 is an observational study that tracks outcomes without assigning an intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, below the 909-participant average among 92 other Glaucoma trials with a reported enrollment target (86% lower).
The record links to 10 conditions, with Glaucoma appearing as the primary indexed condition, and to 1 intervention - of which miLens system is the first listed.
NCT06689696 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06689696 about?
NCT06689696 is a clinical study titled "24-hour Wear Performance and Safety Study of Smartlens miLens Contact Lens for IOP Monitoring". 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...
What is the current status of trial NCT06689696?
This trial is currently recruiting. The enrollment target is 125 participants. The study started on 2025-02-19. Estimated completion is 2026-02.
What conditions does trial NCT06689696 study?
This clinical trial studies the following conditions: Glaucoma, Ocular Hypertension, Glaucoma Open-Angle, Intraocular Pressure, Ocular Hypertension (OH).
What interventions are being tested in trial NCT06689696?
The interventions under investigation include: miLens system (DEVICE).
Who is sponsoring clinical trial NCT06689696?
This trial is sponsored by Smartlens, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06689696 being conducted?
This trial has 3 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06689696's enrollment target sits among peer trials
125 37th of 92 higher than 56 of 92 other Glaucoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glaucoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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