SENSIMED Triggerfish

Study Overview
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Brief Summary
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The purpose of the investigation is to investigate the relationship between the study device output and tonometric assessments.

Detailed Description
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60 subjects will be enrolled in total. Enrolled patients will be randomized into one of 8 device groups of 6 subjects each or into the control group containing 12 subjects. Patients in the device arm will receive one session of 3-to 24-hour continuous IOP monitoring with SENSIMED Triggerfish®. SENSIMED Triggerfish® monitoring will begin at 18h ± 2 hours for all patients. SENSIMED Triggerfish® will be installed randomly on right or left eyes. During SENSIMED Triggerfish® monitoring on one eye, GAT and/or Perkins IOP measurements will be taken in the fellow eye every 3 hours. Outside this time they will receive GAT and/or IOP measurements every 3 hours in both eyes until the end of the 24-hours period. Patients in the control group will receive GAT and/or ICare PRO IOP measurements every 3 hours for 24 hours in both eyes.

Official Title
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Randomized Clinical Investigation to Assess the Efficacy of SENSIMED Triggerfish Continuous IOP Monitoring

Conditions
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Glaucoma

Intervention / Treatment
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* Device: SENSIMED Triggerfish
* Device: Tonometer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent for the investigation Confirmed diagnosis of primary open angle glaucoma or normal tension glaucoma of similar degree in both eyes Age 18-85 Stable anti-glaucomatous therapy 4 weeks before and throughout the investigation Exclusion Criteria: Patients not able to understand the character and individual consequences of the investigation Patients with contraindications for silicone contact lens wear Wear of full frame metallic glasses during SENSIMED Triggerfish® monitoring Diagnosis of pseudoexfoliation syndrome / pseudoexfoliative glaucoma and of pigment dispersion syndrome / pigmentary glaucoma Severe dry eye Patients who have had ocular surgery within the last 3 months Corneal or conjunctival abnormality or irregularity hindering correct contact lens adaptation Allergy to corneal anaesthesia Simultaneous participation in other clinical research

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study device during 3 hours<br> | Device: SENSIMED Triggerfish<br>* Soft contact lens-based device for the continuous monitoring of IOP fluctuations<br>|
| Experimental: Study device during 6 hours<br> | Device: SENSIMED Triggerfish<br>* Soft contact lens-based device for the continuous monitoring of IOP fluctuations<br>|
| Experimental: Study device during 9 hours<br> | Device: SENSIMED Triggerfish<br>* Soft contact lens-based device for the continuous monitoring of IOP fluctuations<br>|
| Experimental: Study device during 12 hours<br> | Device: SENSIMED Triggerfish<br>* Soft contact lens-based device for the continuous monitoring of IOP fluctuations<br>|
| Experimental: Study device during 15 hours<br> | Device: SENSIMED Triggerfish<br>* Soft contact lens-based device for the continuous monitoring of IOP fluctuations<br>|
| Experimental: Study device during 18 hours<br> | Device: SENSIMED Triggerfish<br>* Soft contact lens-based device for the continuous monitoring of IOP fluctuations<br>|
| Experimental: Study device during 21 hours<br> | Device: SENSIMED Triggerfish<br>* Soft contact lens-based device for the continuous monitoring of IOP fluctuations<br>|
| Experimental: Study device during 24 hours<br> | Device: SENSIMED Triggerfish<br>* Soft contact lens-based device for the continuous monitoring of IOP fluctuations<br>|
| Active Comparator: Tonometric assessment during 24 hours<br> | Device: Tonometer<br>* Tonometric assessment of IOP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between study device signal and tonometer reading |  | during 24 hours of study device wear |