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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

December 7, 2009
December 2, 2010
December 2009
October 2010   (final data collection date for primary outcome measure)
Detection of IOP reduction 2 hours after Diamox administration [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01028664 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Use of an Ocular Telemetry Sensor in Diamox Treated Patients
Detection of IOP Fluctuation With SENSIMED Triggerfish in Patients With Glaucoma or Ocular Hypertension Treated With Diamox

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Glaucoma
  • Ocular Hypertension
Device: SENSIMED Triggerfish
2-hour continuous IOP monitoring
Experimental: Glaucoma or ocular hypertension patients
Intervention: Device: SENSIMED Triggerfish
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
October 2010
October 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01028664
09/05
No
Prof. André Mermoud, Clinique de Montchoisi
Sensimed AG
Clinique de Montchoisi, Lausanne, Switzerland
Not Provided
Sensimed AG
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP