SENSIMED Triggerfish Safety and Tolerability

Sensimed

Status

Completed

Conditions

Glaucoma

Treatments

Device: SENSIMED Triggerfish

Study type

Interventional

Funder types

Industry

Identifiers

NCT01319617

10/05

Details and patient eligibility

About

The purpose of this investigation is to study the safety and tolerability of SENSIMED Triggerfish, a soft contact lens-based device intended to continuously record relative changes in intraocular pressure (IOP). The investigation enrols glaucoma patients and glaucoma suspects. All subjects receive two 24-hour recording sessions with the device in an ambulatory setting and at weekly interval. The level of discomfort in the study eye after 24 hours and side effects are the main endpoints of the investigation.

Enrollment

41 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject is able to comply with the study procedures
Subject is 18-80 years old
Glaucoma patient, with glaucomatous optic neuropathy based on clinical assessment of stereoscopic optic disc photographs and/or repeatable abnormal standard automated perimetry (SAP) visual fields at baseline, defined as a pattern standard deviation with P<0.05 or a glaucoma Hemifield test "outside normal limits
Glaucoma suspect, with suspicious optic disc appearance (as determined by subjective assessment on the baseline visit) or elevated IOP (>21 mmHg) but normal and reliable SAP visual fields at baseline
Subject has consented to be in the trial and signed informed consent is available before any study related procedures are carried out
Visual acuity of 20/200 or better in the study eye
Ability of subject to understand the character and individual consequences of the study
For women with childbearing potential, adequate contraception

Exclusion criteria

Subjects with contraindications for wearing contact lenses
Severe dry eye syndrome
Keratoconus or other corneal abnormality
Conjunctival or intraocular inflammation
Eye surgery prior to and throughout the study, except prior uncomplicated cataract surgery a minimum of 3 months prior to the investigation
Full frame metal glasses during SENSIMED Triggerfish® recording
Known hypersensitivity to silicone, plaster or ocular anesthesia
Pregnancy and lactation
Simultaneous participation in other clinical studies