24-hour IOP Pattern With SENSIMED Triggerfish® in a Healthy Population

Study Overview
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Brief Summary
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A database (Snapfish) has been generated at Sensimed compiling all data acquired up to now on healthy volunteers and patients with glaucoma. However, healthy subjects were much younger than glaucoma patients. Additionally, the number of glaucoma patients in Snapfish database was almost twice higher than the number of healthy subjects. As it is generally accepted that intra ocular pressure (IOP) in the aging population is higher than IOP in young adults it is of interest to evaluate the 24-hour IOP pattern of older healthy subjects. Furthermore, improving our knowledge of the healthy 24-hour IOP pattern in comparison to glaucoma profiles would be beneficial for management of glaucoma.

Official Title
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A Prospective, Open Label Study to Assess the 24-hour IOP Pattern Recorded With SENSIMED Triggerfish® in a Healthy Population

Conditions
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Healthy Subject

Intervention / Treatment
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* Device: Sensimed Triggerfish


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject of Caucasian origin Healthy subject without previous ocular disease Aged between 40 and 80 years, of either sex Not more than 6 diopters spherical equivalent in the study eye Having given written informed consent, prior to any investigational procedures Exclusion Criteria: Corneal or conjunctival abnormality precluding contact lens adaptation Previous refractive surgery Occludable or closed iridocorneal angle Sleep apnea syndrome Subjects with allergy to corneal anesthetic Subjects with contraindications for silicone contact lens wear Subjects not able to understand the character and individual consequences of the investigation Participation in other clinical research within the last 4 weeks

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device<br>Portable device that monitors the 24-hour IOP pattern by a wireless contact lens sensor (CLS) placed on the eye that sends its signals via an antenna around the orbital cavity to a recorder. Upon completion, the recording can be transmitted to a computer for read-out and visualization. | Device: Sensimed Triggerfish<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 24-hour IOP pattern recorded with Sensimed Triggerfish (TF) in healthy subjects, aged between 40 and 80 years Secondary |  | 24-hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diurnal and nocturnal IOP patterns in healthy subjects |  | 24 hours | 
| Assessment of corneal biomechanical properties in healthy population (if available) |  | 24 hours | 
| Relationship between the 24-hour IOP pattern monitored by TF and the 24-hour blood pressure pattern in healthy subjects (if available) |  | 24 hours | 
| Assessment of Safety and tolerability through adverse events |  | 6 months |