Use of an Ocular Telemetry Sensor in Tafluprost Treated Patients
NCT ID: NCT01263535
Last Updated: 2012-08-28
Study Results
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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TERMINATED
PHASE4
15 participants
INTERVENTIONAL
2010-09-30
2012-05-31
Brief Summary
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The investigation will recruit male and female patients older than 18 years and diagnosed with glaucoma and treated with tafluprost in both eyes. 20 subjects will be enrolled in the study. Patients will be considered enrolled in the study upon signature of informed consent. A screening visit and one 24-hour IOP fluctuation monitoring session during a 36-hour hospitalisation, are planned for each patient.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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SENSIMED Triggerfish
SENSIMED Triggerfish
Contact lens-based device for the continuous recording of IOP fluctuations, with a portable recording system
Interventions
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SENSIMED Triggerfish
Contact lens-based device for the continuous recording of IOP fluctuations, with a portable recording system
Eligibility Criteria
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Inclusion Criteria
* Untreated IOP of ≥22 mmHg in both eyes.
* Documented, typical glaucomatous visual field (VF) loss (nasal step, or arcuate, paracentral or Seidel's scotoma) determined by automated static threshold perimetry (Octopus 100), and glaucomatous optic nerve head cupping (neural rim notching or saucerization) in both eyes.
* Patients under tafluprost treatment since at least 4 weeks in both eyes.
* Patients who accept signing an informed consent approved by the Ethics Committee.
Exclusion Criteria
* 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 tafluprost or to any of its excipients
* Full-frame metal glasses during monitoring with SENSIMED Triggerfish®
* Pregnancy and lactation
* Simultaneous participation in other clinical research
* Patients with evidence of ocular infection or inflammation
18 Years
ALL
No
Sponsors
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University Hospital, Geneva
OTHER
Sensimed AG
INDUSTRY
Responsible Party
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University Hospital Geneva
Locations
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University Hospital Geneva
Geneva, , Switzerland
Countries
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Other Identifiers
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09/06
Identifier Type: -
Identifier Source: org_study_id