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

NCT06689696 | Completed FDA Device

• 1 other identifier: miLens-002
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 3

Brief 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

Glaucoma; 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); GLAUCOMA 1, OPEN ANGLE, D (Disorder)

Keywords

IOP monitoring; Glaucoma; Contact lens for Glaucoma; Contact lens for IOP monitoring; IOP; Smart contact lens; POAG; Ocular Hypertension; Normal tension Glaucoma; IOP fluctuation

Outcome Measures

Primary Outcomes (3)

• Positive change in miLens output between evening and morning

  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)

  Through study completion, an average of 1 day

• Repeatability of miLens output using correlation between the Day 0 and Week 1 miLens values

  Repeatability of miLens output between Day 0 and Week 1 using correlation between the Day 0 and Week 1 miLens values across the eight time windows (four evening time windows, four morning time windows) for each subject.

  Through study completion, an average of 1 week

• Safety of miLens

  Frequency and percentage of all ocular and non-ocular adverse events (AE) will be reported. AEs will be categorized by seriousness, relation to device, severity, resolution and use of concomitant medication.

  Through study completion, an average of 1 week

Secondary Outcomes (1)

• miLens output and iCare correlation

  Through study completion, an average of 1 day

Study Arms (3)

POAG

primary open angle glaucoma (POAG) including normal tension glaucoma

Device: miLens system

POAG suspect

status as POAG suspect including ocular hypertension (OHTN)

Device: miLens system

Healthy

no prior diagnosis of POAG/POAG suspect

Device: miLens system

Interventions

miLens system DEVICE

The miLens system consists of the miLens contact lens made of soft, biocompatible materials, the miLens imaging system, and miLens analysis software.

Healthy; POAG; POAG suspect

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects, aged between 22 and 80 years with: 1. primary open angle glaucoma (POAG) including normal tension glaucoma 2. status as POAG suspect including ocular hypertension (OHTN) 3. no prior diagnosis of POAG/POAG suspect (the subjects in (a) and (b) will henceforth be referred to as "POAG/OHTN" and subjects in (c) will be referred to as "healthy subjects")

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

Sponsors & Collaborators

• Smartlens, Inc.: lead

Study Sites (3)

Nvision Clinical Reseacrh, LLC

Fullerton, California, 92835, United States

Location

North Bay Eye Associates, Inc.

Petaluma, California, 94954, United States

Location

Nvision Clinical Research, LLC

Torrance, California, 90505, United States

Location

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension; Glaucoma, Open-Angle; Low Tension Glaucoma

Condition Hierarchy (Ancestors)

Eye Diseases; Optic Nerve Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 14, 2024
• Study Start: February 19, 2025
• Primary Completion: August 1, 2025
• Study Completion: January 6, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)