SENSIMED Triggerfish® in Sitting and Supine Position

Healthy Subjects Clinical Trial

Official title:

Assessment of Sitting and Supine Position IOP Using SENSIMED Triggerfish® and Standard Tonometers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01347229
• Other study ID #: 10/06
• Status: Completed
• Phase: N/A
• First received: May 2, 2011
• Last updated: April 16, 2012
• Start date: April 2011
• Est. completion date: April 2012

Study information

• Verified date: April 2012
• Source: Sensimed AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swiss Agency for Therapeutic Products
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate changes in intraocular pressure (IOP) between sitting and supine body positions and correlate the values obtained with conventional tonometers to the output provided by the investigational device.

Description:

20 subjects will be enrolled in the investigation. Eligible subjects will receive one session of 22-hour continuous IOP monitoring with SENSIMED Triggerfish® in ambulatory mode, with body position transitions carried out in-hospital. SENSIMED Triggerfish® will be installed randomly on right or left eyes and the IOP recording will be initiated as soon as the adaptation of the device on the subject's eye is satisfying. Subjects will then go home. The next morning, subjects will return to the hospital and during SENSIMED Triggerfish® monitoring on one eye, IOP measurements will be taken in the fellow eye in sitting position using Goldmann, tonopen and pneuma-tonometers. Then subjects will lie down on a flat bed. After 15 ± 5 minutes and again after 45 ± 5 minutes IOP will be measured in supine position, using Goldmann, tonopen, pneuma-tonometer and Perkins tonometers. Then subjects will sit up again. After 30 ± 5 minutes IOP will be measured with the Goldmann tonometer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject is able to provide informed consent

• Healthy subject, with no previous ocular medical history, with the exception of spectacle vision correction for myopia, hyperopia and astigmatism

• No more than 4 diopters spherical equivalent

• No more than 2 diopters cylinder equivalent

• GAT IOP of less than or equal to 21 mmHg at inclusion and open iridocorneal angles, no history of any IOP > 21 mmHg

• GAT IOP difference between eyes within 1 mmHg during initial exam

• GAT IOP differences between initial sitting and supine positions, between left and right eyes, within 2 mmHg during initial exam

• = 18 years

• 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

• History of eye surgery

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Device:
• SENSIMED Triggerfish®
Soft contact lens-based device for the continuous monitoring of IOP fluctuations

Locations

Country	Name	City	State
Israel	Assaf Harofeh Medical Center	Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Sensimed AG

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in study device signal and GAT IOP between the sitting and supine positions during the sitting-supine sequence		45 minutes	No
Secondary	Difference in Triggerfish® signal and GAT IOP between the sitting and supine positions upon returning to sitting position from supine		30 minutes	No
Secondary	IOP measurements with tonopen and pneuma-tonometer in sitting position, and tonopen, pneuma-tonometer and Perkins in supine position		2 hours	No
Secondary	Monitoring with study device obtained before Day 2		20 hours	No