Sensing Contact Lens-based Device for 24-hour Monitoring of Intraocular Pressure

Study Overview
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Brief Summary
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Glaucoma is characterized by irreversible vision loss through the progressive death of optic nerve fibers unless timely diagnosis and adequate treatment are provided. Medical therapy is aimed at lowering intraocular pressure (IOP) below a clinically determined target level in order to prevent or slow glaucoma progression. IOP is known to vary with the time of day as well as with daily activities. The current way of assessing nycthemeral IOP fluctuation is to perform repeated discrete tonometry measurements, allowing only snapshot and non-continuous measurements once per hour in the best cases. The procedure is cumbersome, expensive, inconvenient (disturbed sleep cycle as patient is awoken for nocturnal/sleep period measurements) and may not detect crucial IOP values in time. Sensimed AG has developed a new contact lens (CL)-based device intended to continuously measure IOP over 24 hours. The objective of this study is to investigate the use of device for 24-hour IOP monitoring in healthy subjects and glaucoma patients.

Official Title
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A Prospective Pilot Study Investigating the Use of a Sensing Contact Lens-based Device for 24-hour Monitoring of Intraocular Pressure in Healthy Subjects and Patients With Open Angle Glaucoma

Conditions
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Glaucoma, Open-Angle, Healthy

Intervention / Treatment
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* Device: Goldfish
* Device: Tonometry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For Open Angle Glaucoma (OAG) subjects, a clinical diagnosis of primary OAG, including normal tension glaucoma (NTG) all known untreated IOP measurements < 22 mmHg using Goldmann Applanation Tonometry (GAT) for NTG no IOP-lowering treatment; otherwise, a 4-week wash-out period prior to the recording For healthy subjects, no structural defects, normal visual fields, IOP ≤ 21 mmHg and open angles on gonioscopy Aged ≥ 18 years, either gender Body Mass Index ≤ 30 kg/m2 Central Corneal Radius (flat meridian) between 7.5 mm (45 D) and 7.9 mm (42.75 D) Central Corneal Thickness between 500 microns and 600 microns Difference in IOP absolute value between eyes within 2.5 mmHg at screening in sitting position Same direction of IOP variation (positive or negative) for the 2 eyes when moving from sitting to supine positions at screening Spherical refraction within ±6.00 diopters and cylinder refraction within ±3.00 diopters Having given written informed consent, prior to any investigational procedures Exclusion Criteria: Ocular pathology (other than glaucoma for glaucoma subjects) Previous glaucoma, cataract or refractive surgery Corneal or conjunctival abnormality, precluding contact lens adaptation Severe dry eye syndrome Subjects with allergy to corneal anesthetic Subjects with contraindications for silicone CL wear Subjects with contraindications for Water Drinking Test (WDT) (eg., heart, renal problems) Subjects unable or unwilling to comply with the study procedures Participation in other interventional clinical research within the last 4 weeks

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational device (Goldfish)<br>IOP will be monitored for 24 h in the Goldfish eye | Device: Goldfish<br>* Goldfish will be placed in the eye for 24h monitoring<br>|
| Active Comparator: Tonometry<br>IOP will be acquired by standard tonometry at specific times in the the fellow eye | Device: Tonometry<br>* Fellow eye will be measured by tonometry<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in IOP assessed by Goldfish following known physiological and induced changes in IOP | IOP will be measured using tonometry in the fellow eye and compared to IOP measured in the Goldfish eye with the Goldfish device | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects completing 24-hour session with Goldfish | Percentage of subject completing the session will be calculated at the end of the study | 24 hours | 
| Wearing discomfort of Goldfish based on visual analogue scale | Tolerability of the Goldfish lens will be subjectively evaluated before and after GF wear using a visual analogue scale from 0 (no discomfort) to 100 (severe discomfort) mm | 24 hours | 
| Evaluation of Goldfish technical performance based on the percentage of valid Goldfish measurements | Percentage of valid measurement will be calculated at the end of each monitoring session | 24 hours | 
| Correlation between IOP and ocular pulse amplitude (OPA) assessed by Goldfish in the Goldfish eye and IOP and OPA measured by tonometry in the fellow eye | OPA will be extracted from the Goldfish signal in the Goldfish eye and measured by tonometry in the fellow eye. Both IOP and OPA measurement will be compared between fellow eyes | 24 hours | 
| Relationship between Goldfish IOP and blood pressure (BP) measurements over 24 hours | IOP signal acquired with Goldfish will be compared to BP signal assessed with a BP holter | 24 hours |