SENSIMED Triggerfish in Closed Eyes

Glaucoma Clinical Trial

Official title:

A Prospective, Open Label Study to Assess the 24-hour Intraocular Pressure Pattern Recorded With SENSIMED Triggerfish® in Healthy Subjects With Closed Eye

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01938287
• Other study ID #: TF-1301
• Status: Completed
• Phase: Phase 4
• First received: July 26, 2013
• Last updated: November 16, 2015
• Start date: July 2013
• Est. completion date: February 2014

Study information

• Verified date: November 2015
• Source: Sensimed AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

This study investigates the effect of eye opening/closure on the quality of IOP (intraocular pressure) related patterns recorded with SENSIMED Triggerfish. Each subject receives 2 24-hour recording sessions, one with the recorded eye open and the other with the eye closed,using an ophthalmic patch.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: February 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Healthy subject without previous ophthalmic medical history (except from indication for glasses)

• Aged =18 years, of either sex

• Have given written informed consent, prior to any investigational procedures

Exclusion Criteria:

• Patients with allergy to corneal anesthetic

• Patients with contraindications for silicone contact lens wear

• Patients not able to understand the character and individual consequences of the investigation

• Participation in other clinical research within the last 4 weeks

Study Design

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• SENSIMED Triggerfish

Locations

Country	Name	City	State
Switzerland	HUG, Department of Ophthalmology, Glaucoma Sector	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Sensimed AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference between start and end TF (SENSIMED Triggerfish) in a closed eye as compared to the difference between start to end TF in an open eye	TF will be installed on subjects' eyes for 24 hours in two sessions. In one session the eye will remain open (except during sleep) while in the other session the eye will be closed using an ophthalmic patch throughout the 24 hours. For both sessions, the initial TF output value in millivolt equivalent will be subtracted from the final output value to yield the difference from start to end. The difference obtained in the session with closed eye will be divided by that of the session with open eye (ratio).	24 hours	No