Use of an Ocular Telemetry Sensor in Tafluprost Treated Patients

This study has been terminated.
Sponsor:
Collaborator:
University Hospital, Geneva
Information provided by:
Sensimed AG
ClinicalTrials.gov Identifier:
NCT01263535
First received: December 2, 2010
Last updated: August 27, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Glaucoma
Device: SENSIMED Triggerfish
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Circadian Continuous Intraocular Pressure Monitoring With SENSIMED Triggerfish® Ocular Telemetry Sensor in Patients on Tafluprost Treatment

Resource links provided by NLM:


Further study details as provided by Sensimed AG:

Primary Outcome Measures:
  • Acquisition of 24-hour Sensor output signal [ Time Frame: After 24-hour continuous recording ] [ Designated as safety issue: No ]
    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:
  • Possible IOP fluctuation [ Time Frame: After 24-hour recording with study device ] [ Designated as safety issue: No ]
    Fluctuation is defined as a change of 25% or more from the mean Sensor output over 24 hours for each participant.


Enrollment: 15
Study Start Date: September 2010
Study Completion Date: May 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SENSIMED Triggerfish Device: SENSIMED Triggerfish
Contact lens-based device for the continuous recording of IOP fluctuations, with a portable recording system

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01263535

Locations
Switzerland
University Hospital Geneva
Geneva, Switzerland, 1211
Sponsors and Collaborators
Sensimed AG
University Hospital, Geneva
  More Information

No publications provided

Responsible Party: Dr Tarek Shaarawy, University Hospital Geneva
ClinicalTrials.gov Identifier: NCT01263535     History of Changes
Other Study ID Numbers: 09/06
Study First Received: December 2, 2010
Last Updated: August 27, 2012
Health Authority: Switzerland: Swiss agency for therapeutic products

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on July 29, 2014