24-hour IOP Pattern With SENSIMED Triggerfish® in a Healt... | NCT01906502

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

NCT01906502

Sponsor

Sensimed AG

Status

Completed

Last Update Posted

Aug 26, 2014Estimated

Enrollment

115Actual

Phase

Not Applicable

Conditions

Healthy Subject

Interventions

Sensimed Triggerfish

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Apr 2014Actual

Completion Date

Apr 2014Actual

First Submitted Date

Jul 17, 2013

First Submission Date that Met QC Criteria

Jul 20, 2013

First Posted Date

Jul 24, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 25, 2014

Last Update Posted Date

Aug 26, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

115Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Device	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sensimed Triggerfish	Device		Device

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Moshe Lusky, MD	Rabin Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Meir Medical Center		Kfar Saba			Israel
The Western Galilee Hospital in Naharya