SENSIMED Triggerfish Safety and Tolerability

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Diego

San Diego, California, 92093-0946, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SENSIMED Triggerfish

Device

Soft contact lens-based device intended for continuous recording of relative changes in IOP

Primary outcomes

Ocular Discomfort

Time frame: After 24 hours of device wear

Ocular discomfort in the study eye is reported by patients on a 100-mm visual analog scale (left end 0 mm, no discomfort; right end 100 mm, very severe discomfort) as the distance from the left end to the patient's mark after wearing the device for 24 hours at two occasions separated by one week. Values for both sessions were averaged.

Sponsors and collaborators

Lead sponsor

Sensimed AG

Industry

Registry information

Official study title

Evaluation of SENSIMED Triggerfish Safety and Tolerability in Glaucoma Patients and Glaucoma Suspects

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Mar 21, 2011
Registry last updated: Sep 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed