Glaucoma
Conditions
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.
Interventions
DEVICESENSIMED Triggerfish
Soft contact lens-based device intended for continuous recording of relative changes in IOP
Sponsors
Sensimed AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Discomfort | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment from medical clinic from January to September 2011
Participants by arm
| Arm | Count |
|---|---|
| SENSIMED Triggerfish SENSIMED Triggerfish is a device containing a soft silicone contact lens sensor detecting ocular dimensional changes related to IOP through an integrated strain gauge. The device energy and data transfer between the contact lens sensor and the external recording and data storage unit is done using telemetry.
All study subjects received SENSIMED Triggerfish on one eye for 24 hours at two occasions in ambulatory mode, without restriction of activities apart from those contraindicated by the device instructions for use. The device was installed and removed by the study staff during visits to the study center | 41 |
| Total | 41 |
Baseline characteristics
| Characteristic | SENSIMED Triggerfish |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 13 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants |
| Age Continuous | 54.6 years STANDARD_DEVIATION 16.5 |
| Region of Enrollment United States | 41 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 39 / 41 |
| serious Total, serious adverse events | 0 / 41 |
Outcome results
Primary
Ocular Discomfort
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.
Time frame: After 24 hours of device wear
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SENSIMED Triggerfish | Ocular Discomfort | 25.5 mm | Standard Deviation 18.6 |