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Use of an Ocular Telemetry Sensor in Tafluprost Treated Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE December 2, 2010
First Posted Date  ICMJE December 20, 2010
Last Update Posted Date August 28, 2012
Study Start Date  ICMJE September 2010
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2010)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of an Ocular Telemetry Sensor in Tafluprost Treated Patients
Official Title  ICMJE Circadian Continuous Intraocular Pressure Monitoring With SENSIMED Triggerfish® Ocular Telemetry Sensor in Patients on Tafluprost Treatment
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Glaucoma
Intervention  ICMJE Device: SENSIMED Triggerfish
Contact lens-based device for the continuous recording of IOP fluctuations, with a portable recording system
Study Arms  ICMJE Experimental: SENSIMED Triggerfish
Intervention: Device: SENSIMED Triggerfish
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 27, 2012)
15
Original Estimated Enrollment  ICMJE
 (submitted: December 17, 2010)
20
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01263535
Other Study ID Numbers  ICMJE 09/06
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Tarek Shaarawy, University Hospital Geneva
Study Sponsor  ICMJE Sensimed AG
Collaborators  ICMJE University Hospital, Geneva
Investigators  ICMJE Not Provided
PRS Account Sensimed AG
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP