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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
History of Changes
  Purpose

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.


Condition Intervention
Glaucoma
Ocular Hypertension
 Device: SENSIMED Triggerfish

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Detection of IOP Fluctuation With SENSIMED Triggerfish in Patients With Glaucoma or Ocular Hypertension Treated With Diamox

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sensimed AG:

Primary Outcome Measures:
  • Detection of IOP reduction 2 hours after Diamox administration [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glaucoma or ocular hypertension patients Device: SENSIMED Triggerfish
2-hour continuous IOP monitoring

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01028664

Locations
Switzerland
Clinique de Montchoisi, Centre du Glaucome
Lausanne, Switzerland, 1006
Sponsors and Collaborators
Sensimed AG
Clinique de Montchoisi, Lausanne, Switzerland
  More Information

No publications provided

Responsible Party: Prof. André Mermoud, Clinique de Montchoisi
ClinicalTrials.gov Identifier: NCT01028664     History of Changes
Other Study ID Numbers: 09/05
Study First Received: December 7, 2009
Last Updated: December 2, 2010
Health Authority: Switzerland: Commission cantonale d'éthique de la recherche sur l'être humain

Keywords provided by Sensimed AG:
Glaucoma and ocular hypertension patients

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
 Eye Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013