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OpenTrials
Completed

NCT Number: NCT01028664

Use of an Ocular Telemetry Sensor in Diamox Treated Patients

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique de Montchoisi, Centre du Glaucome

Lausanne, 1006, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SENSIMED Triggerfish

Device

2-hour continuous IOP monitoring

Primary outcomes

  1. Detection of IOP reduction 2 hours after Diamox administration

    Time frame: 2 hours

Sponsors and collaborators

Lead sponsor

Sensimed AG

Industry

Collaborators

  • Clinique de Montchoisi, Lausanne, Switzerland

Registry information

Official study title

Detection of IOP Fluctuation With SENSIMED Triggerfish in Patients With Glaucoma or Ocular Hypertension Treated With Diamox

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 9, 2009
Registry last updated
Dec 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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