Clinical trial NCT01319617: SENSIMED Triggerfish Safety and Tolerability
Official title: Evaluation of SENSIMED Triggerfish Safety and Tolerability in Glaucoma Patients and Glaucoma Suspects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Lead sponsor: Sensimed AG
Sponsor class: INDUSTRY
First posted: 2011-03-21
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Ocular Discomfort
timeFrame: After 24 hours of device wear
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Felipe Medeiros, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mansouri K, Medeiros FA, Tafreshi A, Weinreb RN. Continuous 24-hour monitoring of intraocular pressure patterns with a contact lens sensor: safety, tolerability, and reproducibility in patients with glaucoma. Arch Ophthalmol. 2012 Dec;130(12):1534-9. doi: 10.1001/jamaophthalmol.2013.1350.
citation: Mansouri K, Liu JH, Weinreb RN, Tafreshi A, Medeiros FA. Analysis of continuous 24-hour intraocular pressure patterns in glaucoma. Invest Ophthalmol Vis Sci. 2012 Dec 13;53(13):8050-6. doi: 10.1167/iovs.12-10569.
citation: Mansouri K, Medeiros FA, Tafreshi A, Weinreb RN. Continuous 24-hour monitoring of intraocular pressure patterns with a contact lens sensor: safety, tolerability, and reproducibility in patients with glaucoma. Arch Ophthalmol. 2012 Dec;130(12):1534-9. doi: 10.1001/archophthalmol.2012.2280.