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 range22 Years – 80 Years
SexALL
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)
✓. 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
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
✕. 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