Use of an Ocular Telemetry Sensor in Diamox Treated Patients

This study has been completed.

Sponsor:

Collaborator:

Clinique de Montchoisi, Lausanne, Switzerland

Information provided by:

Sensimed AG

ClinicalTrials.gov Identifier:

NCT01028664

First received: December 7, 2009

Last updated: December 2, 2010

Last verified: December 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	December 7, 2009
Last Updated Date	December 2, 2010
Start Date ^ICMJE	December 2009
Primary Completion Date	October 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 8, 2009)	Detection of IOP reduction 2 hours after Diamox administration [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01028664 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Use of an Ocular Telemetry Sensor in Diamox Treated Patients
Official Title ^ICMJE	Detection of IOP Fluctuation With SENSIMED Triggerfish in Patients With Glaucoma or Ocular Hypertension Treated With Diamox
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
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care
Condition ^ICMJE	Glaucoma Ocular Hypertension
Intervention ^ICMJE	Device: SENSIMED Triggerfish 2-hour continuous IOP monitoring
Study Arm (s)	Experimental: Glaucoma or ocular hypertension patients Intervention: Device: SENSIMED Triggerfish
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	20
Completion Date	October 2010
Primary Completion Date	October 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Switzerland

Administrative Information
NCT Number ^ICMJE	NCT01028664
Other Study ID Numbers ^ICMJE	09/05
Has Data Monitoring Committee	No
Responsible Party	Prof. André Mermoud, Clinique de Montchoisi
Study Sponsor ^ICMJE	Sensimed AG
Collaborators ^ICMJE	Clinique de Montchoisi, Lausanne, Switzerland
Investigators ^ICMJE	Not Provided
Information Provided By	Sensimed AG
Verification Date	December 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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