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Use of an Ocular Telemetry Sensor in Diamox Treated Patients

NCT ID: NCT01028664

Last Updated: 2010-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Glaucoma Ocular Hypertension

Keywords

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Glaucoma and ocular hypertension patients

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Glaucoma or ocular hypertension patients

Group Type EXPERIMENTAL

SENSIMED Triggerfish

Intervention Type DEVICE

2-hour continuous IOP monitoring

Interventions

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SENSIMED Triggerfish

2-hour continuous IOP monitoring

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinique de Montchoisi, Lausanne, Switzerland

UNKNOWN

Sponsor Role collaborator

Sensimed AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Clinique de Montchoisi

Locations

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Clinique de Montchoisi, Centre du Glaucome

Lausanne, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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09/05

Identifier Type: -

Identifier Source: org_study_id