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

Primary Purpose

Glaucoma, Open-Angle, Healthy

Status

Completed

Phase

Not Applicable

Locations

Poland

Study Type

Interventional

Intervention

Goldfish

Tonometry

About this trial

This is an interventional device feasibility trial for Glaucoma, Open-Angle

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

[W]-Eye clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Investigational device (Goldfish)

Tonometry

Arm Description

IOP will be monitored for 24 h in the Goldfish eye

IOP will be acquired by standard tonometry at specific times in the the fellow eye

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of subjects completing 24-hour session with Goldfish

Percentage of subject completing the session will be calculated at the end of the study

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

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

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

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

Full Information

NCT ID

NCT03689088

First Posted

September 21, 2018

Last Updated

November 30, 2018

Sponsor

Sensimed AG

1. Study Identification

Unique Protocol Identification Number

NCT03689088

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

May 22, 2018 (Actual)

Primary Completion Date

July 4, 2018 (Actual)

Study Completion Date

September 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sensimed AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma, Open-Angle, Healthy

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Investigational device (Goldfish)

Arm Type

Experimental

Arm Description

IOP will be monitored for 24 h in the Goldfish eye

Arm Title

Tonometry

Arm Type

Active Comparator

Arm Description

IOP will be acquired by standard tonometry at specific times in the the fellow eye

Intervention Type

Device

Intervention Name(s)

Goldfish

Intervention Description

Goldfish will be placed in the eye for 24h monitoring

Intervention Type

Device

Intervention Name(s)

Tonometry

Intervention Description

Fellow eye will be measured by tonometry

Primary Outcome Measure Information:

Title

Changes in IOP assessed by Goldfish following known physiological and induced changes in IOP

Description

IOP will be measured using tonometry in the fellow eye and compared to IOP measured in the Goldfish eye with the Goldfish device

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Percentage of subjects completing 24-hour session with Goldfish

Description

Percentage of subject completing the session will be calculated at the end of the study

Time Frame

24 hours

Title

Wearing discomfort of Goldfish based on visual analogue scale

Description

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

Time Frame

24 hours

Title

Evaluation of Goldfish technical performance based on the percentage of valid Goldfish measurements

Description

Percentage of valid measurement will be calculated at the end of each monitoring session

Time Frame

24 hours

Title

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

Description

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

Time Frame

24 hours

Title

Relationship between Goldfish IOP and blood pressure (BP) measurements over 24 hours

Description

IOP signal acquired with Goldfish will be compared to BP signal assessed with a BP holter

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert Wasilewicz, MD

Organizational Affiliation

[W]-Eye Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

[W]-Eye clinic

City

Poznań

ZIP/Postal Code

61-048

Country

Poland

12. IPD Sharing Statement

Plan to Share IPD

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

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