Use of an Ocular Telemetry Sensor in Diamox Treated Patients | NCT01028664

Studies
Use of an Ocular Telemetry Sensor in Diamox Treated Patients

NCT01028664

Sponsor

Sensimed AG

Status

Completed

Last Update Posted

Dec 3, 2010Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Glaucoma
Ocular Hypertension

Interventions

SENSIMED Triggerfish

Countries

Switzerland

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

Dec 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

Dec 2009

Primary Completion Date

Oct 2010Actual

Completion Date

Oct 2010Actual

First Submitted Date

Dec 7, 2009

First Submission Date that Met QC Criteria

Dec 8, 2009

First Posted Date

Dec 9, 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

Dec 2, 2010

Last Update Posted Date

Dec 3, 2010Estimated

Name	Class
Clinique de Montchoisi, Lausanne, Switzerland	UNKNOWN

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 soft contact lens integrating a Sensor is placed on subjects with high intraocular pressure (IOP) after administration of an IOP-lowering drug to investigate the device's capacity to detect the induced IOP reduction.

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Glaucoma or ocular hypertension patients	Experimental		Device: SENSIMED Triggerfish

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SENSIMED Triggerfish	Device	2-hour continuous IOP monitoring	Glaucoma or ocular hypertension patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Detection of IOP reduction 2 hours after Diamox administration		2 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed diagnosis of glaucoma or ocular hypertension
IOP of ≥ 15 mmHg.
Patients of either gender.
Older than 18 years.
Patients who accept signing an informed consent approved by the Ethics Committee.

Exclusion Criteria:

Patients not able to understand the nature of the research
Patients under tutorship
Corneal abnormalities in both eyes
Subjects with contraindications for wearing contact lenses
History of ocular surgery within the last 3 months
Known hypersensitivity to Diamox® or to any of its excipients
Pregnancy and lactation
Simultaneous participation in other clinical research
Patients with evidence of ocular infection or inflammation
History of renal or hepatic impairment, hypokalemia and hyponatremia

Accepts Healthy Volunteers

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinique de Montchoisi, Centre du Glaucome		Lausanne		1006	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension

Ancestor Terms

ID	Term
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided