24-hour Wear Performance and Safety Study of Smartlens miLens Contact Lens for IOP Monitoring (NCT06689696) | Clinical Trial Compass
CompletedNot Applicable
24-hour Wear Performance and Safety Study of Smartlens miLens Contact Lens for IOP Monitoring
United States86 participantsStarted 2025-02-19
Plain-language 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.
Who can participate
Age range
22 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects ≥22 to ≤80 years of age
. Subjects with:
. In subjects with no history of POAG/OHTN, GAT IOP difference between eyes must be ≤ 2 mmHg, with IOP no less than 10 mmHg in both eyes and no greater than 21 mmHg in both eyes.
. Mean keratometry value is between 7.5 mm and 8.2 mm in at least one eye (the miLens eye)
. GEN4 miLens contact lens fitting on the subject's eye is acceptable by a slit lamp exam at Day 0 (measurement study visit)
. Subjects with ability to discontinue habitual IOP-lowering medications, if any, in both eyes on Day 0 visit until the end of the 24-hour wear period (and if applicable, similarly for the Week 1 visit) (No preservative-free topical glaucoma medications will be allowed for the duration of the study)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Positive change in miLens output between evening and morning
Timeframe: Through study completion, an average of 1 day
2
Repeatability of miLens output using correlation between the Day 0 and Week 1 miLens values
Timeframe: Through study completion, an average of 1 week
3
Safety of miLens
Timeframe: Through study completion, an average of 1 week
. Able to understand, sign and complete the informed consent and available to complete the minimum set of self-acquired smartphone images over the 24-hour contact lens wear period, preferably at an assigned site and likely available for a repeat session after a week
Exclusion criteria
. BCVA worse than 20/200 in either eye
. Greater than 6 diopters spherical equivalent in either eye
. Greater than 3 diopters of keratometric cylinder in either eye
. Central corneal thickness greater than 0.60 mm or less than 0.50 mm in either eye (per GAT study guidelines in ANSI Z80.10)
. Known history of difficulty in obtaining Goldmann IOP measurements or any factors that might contribute to inaccurate Goldmann IOP measurements (e.g. lid squeezing or tremor)
. Subjects who have had ocular surgery within the last 6 months in either eye
. Subjects who have had corneal refractive surgery
. History of Keratoconus, corneal scarring, or other chronic corneal disease in either eye