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

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

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma, Open-Angle; Healthy
• Intervention / Treatment: Device: Goldfish; Device: Tonometry

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Poznań, Poland, 61-048
    • [W]-Eye clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Investigational device (Goldfish); IOP will be monitored for 24 h in the Goldfish eye	Device: Goldfish; Goldfish will be placed in the eye for 24h monitoring
ACTIVE_COMPARATOR: Tonometry; IOP will be acquired by standard tonometry at specific times in the the fellow eye	Device: Tonometry; Fellow eye will be measured by tonometry

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sensimed AG
• Investigators: Principal Investigator: Robert Wasilewicz, MD, [W]-Eye clinic

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 22, 2018
• Primary Completion (ACTUAL): July 4, 2018
• Study Completion (ACTUAL): September 6, 2018

Study Registration Dates

• First Submitted: September 21, 2018
• First Submitted That Met QC Criteria: September 21, 2018
• First Posted (ACTUAL): September 28, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 4, 2018
• Last Update Submitted That Met QC Criteria: November 30, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: GF-1703

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No