Use of an Ocular Telemetry Sensor in Diamox Treated Patients

• Sponsor: Sensimed AG (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01028664
• Collaborator: Clinique de Montchoisi, Lausanne, Switzerland (Other)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 10
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma; Ocular Hypertension	Device: SENSIMED Triggerfish	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Dec 1, 2009
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Glaucoma or ocular hypertension patients	Device: SENSIMED Triggerfish; 2-hour continuous IOP monitoring

Outcome Measures

Primary Outcome Measures

1. Detection of IOP reduction 2 hours after Diamox administration [2 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Clinique de Montchoisi, Centre du Glaucome	Lausanne		Switzerland	1006

Sponsors and Collaborators

• Sensimed AG
• Clinique de Montchoisi, Lausanne, Switzerland

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01028664
• Other Study ID Numbers: 09/05
• First Posted: Dec 9, 2009
• Last Update Posted: Dec 3, 2010
• Last Verified: Dec 1, 2010

• Keywords provided by , ,: Glaucoma and ocular hypertension patients
• Additional relevant MeSH terms: Glaucoma; Ocular Hypertension; Hypertension

Study Results

No Results Posted as of Dec 3, 2010