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.
This study will enroll healthy participants and those with primary open-angle glaucoma or ocular hypertension from a minimum of two and up to 10 research sites in US. All participants will be informed about the study and its potential risks and required to provide written informed consent prior to undergoing study-related procedures. Participants will be screened for eligibility. The study will be conducted in a 24-hour session in eligible subjects, preferably at a hotel or similar location that allows overnight stay. For subjects who complete the first session at a hotel and are able to return in a week, the study will be repeated in another 24-hour session. At the beginning of the 24-hour session, the study staff will place the miLens in the study eye. The study eye is designated as the eye with higher intraocular pressure (IOP) or randomly selected if IOP is equal. Participants will be asked to capture miLens measurements using smartphone camera. The miLens smartphone app will auto-adjust zoom and capture image, which will be automatically sent to the cloud-based image processing software. The participants will be asked to capture miLens images every 15 minutes over 24 hours, except during sleep time between 10:30 pm and 5:30 am. The study staff will also measure IOP in the other eye using a tonometer every 1-2 hours. In addition, participants will be asked to rate comfort on a numerical scale to assess tolerability to lens wear. Safety is assessed by biomicroscopy examination and by measuring vision and refraction before and after the session. The 24-hour session is repeated after 6-8 days, starting at around the same time as the first session, in the same study eye.
Study Type
OBSERVATIONAL
Enrollment
125
The miLens system consists of the miLens contact lens made of soft, biocompatible materials, the miLens imaging system, and miLens analysis software.
Nvision Clinical Reseacrh, LLC
Fullerton, California, United States
RECRUITINGNorth Bay Eye Associates, Inc.
Petaluma, California, United States
RECRUITINGNvision Clinical Research, LLC
Torrance, California, United States
RECRUITINGPositive 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)
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, an average of 1 week
miLens output and iCare correlation
Correlation between iCare measurements (FE) and corresponding miLens measurements.
Time frame: Through study completion, an average of 1 day
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