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24-hour Wear Performance and Safety Study of Smartlens miLens Contact Lens for IOP Monitoring
NCT06689696 · View on ClinicalTrials.gov ↗
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 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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06689696
The ClinicalTrials.gov registry entry for NCT06689696 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Smartlens, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06689696 reports 3 study locations spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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, Intraocular Pressure, Ocular Hypertension (OH), Glaucoma Open-Angle. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06689696?
The interventions under investigation include: miLens system (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06689696?
This trial is sponsored by Smartlens, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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