Use of an Ocular Telemetry Sensor in Diamox Treated Patients

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01028664
• Other study ID #: 09/05
• Status: Completed
• Phase: N/A
• First received: December 7, 2009
• Last updated: December 2, 2010
• Start date: December 2009
• Est. completion date: October 2010

Study information

• Verified date: December 2010
• Source: Sensimed AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Commission cantonale d'éthique de la recherche sur l'être humain
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Glaucoma
• Hypertension
• Ocular Hypertension

Intervention

Device:
• SENSIMED Triggerfish
2-hour continuous IOP monitoring

Locations

Country	Name	City	State
Switzerland	Clinique de Montchoisi, Centre du Glaucome	Lausanne

Sponsors (2)

Lead Sponsor	Collaborator
Sensimed AG	Clinique de Montchoisi, Lausanne, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of IOP reduction 2 hours after Diamox administration		2 hours	No