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

NCT03689088 | Completed

• 1 other identifier: GF-1703
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma, Open-Angle; Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Percentage of subjects completing 24-hour session with Goldfish

  24 hours

• Wearing discomfort of Goldfish based on visual analogue scale

  24 hours

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

  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

  24 hours

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

  24 hours

Study Arms (2)

Investigational device (Goldfish)

EXPERIMENTAL

IOP will be monitored for 24 h in the Goldfish eye

Device: Goldfish

Tonometry

ACTIVE COMPARATOR

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

Device: Tonometry

Interventions

Goldfish DEVICE

Goldfish will be placed in the eye for 24h monitoring

Investigational device (Goldfish)

Tonometry DEVICE

Fellow eye will be measured by tonometry

Tonometry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sensimed AG: lead

Study Sites (1)

[W]-Eye clinic

Poznan, 61-048, Poland

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Manometry

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Robert Wasilewicz, MD

  [W]-Eye Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2018
• First Posted: September 28, 2018
• Study Start: May 22, 2018
• Primary Completion: July 4, 2018
• Study Completion: September 6, 2018
• Last Updated: December 4, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)