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

Completed

Conditions studied: 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)

In brief

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.

Key facts

Study ID: NCT06689696
Run by: Smartlens, Inc.
People needed: 86
Starts: 2025-02-19
Expected to finish: 2026-01-06
Last updated by the study team: 2026-04-01

Who can join

Age: 22 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Subjects ≥22 to ≤80 years of age
Subjects with:
prior diagnosis of POAG in at least one eye, including normal tension glaucoma or prior diagnosis of POAG suspect including OHTN in at least one eye for whom no evidence or suspicion of structural or functional glaucomatous damage exists
Diagnosis of POAG from medical records characterized by open angles and (1) optic nerve cupping consistent with glaucoma, with diffuse or focal thinning of neuroretinal rim or nerve fiber layer defects or a difference in cup/disc ratio > 0.2, not explained by anisometropia or other non-glaucomatous causes (2) visual field defects consistent with optic nerve cupping, with glaucomatous hemifield test outside normal limits or a pattern standard deviation (PSD) worse than 5th percentile (P<0.05) by Standard Automated Perimetry, or VF defects with Goldmann visual field test consistent with glaucomatous nerve fiber layer loss including paracentral scotoma, nasal step or arcuate defects
Diagnosis of POAG suspect from medical records established by open angles and IOP ≥22 mmHg (OHTN) OR abnormal appearing optic disc appearance OR glaucomatous visual field defects
no prior history of POAG/OHTN in either eye
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

You may not qualify if…

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
Subjects with contraindication for wearing contact lenses or history of intolerance or difficulties associated with contact lens use including history of dry eye disease
Subjects with current signs/symptoms of clinically significant dry eye disease
Active eye disease, injury or ocular abnormalities affecting the cornea, conjunctiva, or eyelids or slit lamp findings ≥ grade 3
Active inflammation of either eye
Active infection of either eye
Corneal vascularization of either eye
Known allergy to silicone
Known allergy to corneal anesthetic
Secondary forms of open angle glaucoma (OAG) in either eye
Poor or eccentric fixation in either eye
Nystagmus
Microphthalmos of either eye
Buphthalmos of either eye
Subject is pregnant, lactating or planning to become pregnant during the course of the study
Concurrent participation in any clinical trial
Disabling arthritis or limited motor coordination that might limit self-handling of a smart phone with miLens eyepiece attached.
Experience using or interacting with miLens and smartphone imaging app during a previous usability or clinical trial

Where it is running

Nvision Clinical Reseacrh, LLC — Fullerton, California, United States
North Bay Eye Associates, Inc. — Petaluma, California, United States
Nvision Clinical Research, LLC — Torrance, California, United States

Full record on ClinicalTrials.gov

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