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Use of an Ocular Telemetry Sensor in Tafluprost Treated Patients

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ClinicalTrials.gov Identifier: NCT01263535
Recruitment Status : Terminated
First Posted : December 20, 2010
Last Update Posted : August 28, 2012
Sponsor:
Collaborator:
University Hospital, Geneva
Information provided by:
Sensimed AG

Study Description
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Brief Summary:

This clinical trial is designed to investigate the performance of SENSIMED Triggerfish® during 24-hour continuous IOP fluctuation monitoring, defined as the number of valid recording intervals over the 24-hour period.

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.


Condition or disease Intervention/treatment Phase
Glaucoma Device: SENSIMED Triggerfish Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Circadian Continuous Intraocular Pressure Monitoring With SENSIMED Triggerfish® Ocular Telemetry Sensor in Patients on Tafluprost Treatment
Study Start Date : September 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: SENSIMED Triggerfish Device: SENSIMED Triggerfish
Contact lens-based device for the continuous recording of IOP fluctuations, with a portable recording system


Outcome Measures
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Primary Outcome Measures :
  1. Acquisition of 24-hour Sensor output signal [ Time Frame: After 24-hour continuous recording ]
    Performance is assessed as the portion of valid data (actual number of valid data points recorded compared to expected number of recorded data points) during 24-hour recording.


Secondary Outcome Measures :
  1. Possible IOP fluctuation [ Time Frame: After 24-hour recording with study device ]
    Fluctuation is defined as a change of 25% or more from the mean Sensor output over 24 hours for each participant.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Older than 18 years.
  • 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 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 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01263535


Locations
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Switzerland
University Hospital Geneva
Geneva, Switzerland, 1211
Sponsors and Collaborators
Sensimed AG
University Hospital, Geneva
More Information
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Responsible Party: Dr Tarek Shaarawy, University Hospital Geneva
ClinicalTrials.gov Identifier: NCT01263535    
Other Study ID Numbers: 09/06
First Posted: December 20, 2010    Key Record Dates
Last Update Posted: August 28, 2012
Last Verified: August 2012
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases