SENSIMED Triggerfish Discomfort During IOP Monitoring | NCT00966108

Studies
SENSIMED Triggerfish Discomfort During IOP Monitoring

NCT00966108

Sponsor

Sensimed AG

Status

Completed

Last Update Posted

Feb 4, 2010Estimated

Enrollment

40Actual

Phase

Not provided

Conditions

Safety and Tolerability of SENSIMED Triggerfish in Glaucoma Patients

Interventions

SENSIMED Triggerfish

Countries

Germany

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

Feb 2010

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

Aug 2009

Primary Completion Date

Jan 2010Actual

Completion Date

Jan 2010Actual

First Submitted Date

Aug 24, 2009

First Submission Date that Met QC Criteria

Aug 24, 2009

First Posted Date

Aug 26, 2009Estimated

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

Feb 3, 2010

Last Update Posted Date

Feb 4, 2010Estimated

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

Evaluation of the wearing discomfort (safety and tolerability) involved during IOP monitoring with the SENISMED Triggerfish, a sensor embedded in a telemetric contact lens

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy subjects			Device: SENSIMED Triggerfish
Glaucoma patients			Device: SENSIMED Triggerfish

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SENSIMED Triggerfish	Device	Ocular Telemetry Sensor for IOP monitoring	Glaucoma patients Healthy subjects

Measure	Description	Time Frame
ocular discomfort on a visual analogue scale		24 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient is able to comply with the study procedure
Patient is 18-80 years old
Healthy subject or glaucoma patient
Patient has consented to be in the trial and signed informed consent is available before any study related procedures are carried out
Cylinder refraction of no more than +/- 2 diopters in the study eye
Visual acuity of 20/80 or better in the study eye
Ability of subject to understand the character and individual consequences of the study
For women with childbearing potential, adequate contraception

Exclusion Criteria:

Subjects wearing contact lenses within the last two years
Subjects with contraindications for wearing contact lenses
History of refractive surgery
History of intraocular surgery in the last three months
Severe dry eye syndrome
Keratoconus or other corneal abnormalities
Conjunctival or intraocular inflammation
Pregnancy and lactation
Simultaneous participation in other clinical trials

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy subjects and glaucoma patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Norbert Pfeiffer, Prof. Dr. med.	Universitätsmedizin Mainz	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitätsmedizin der Johannes Gutenberg-Universität Mainz		Mainz	Rhineland-Palatinate	55131	Germany