Back to resultsUse of an Ocular Telemetry Sensor in Tafluprost Treated Patients
Primary Purpose
Glaucoma
Status
Terminated
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
SENSIMED Triggerfish
Sponsored by
About this trial
This is an interventional diagnostic trial for Glaucoma
Eligibility 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
Sites / Locations
- University Hospital Geneva
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SENSIMED Triggerfish
Arm Description
Outcomes
Primary Outcome Measures
Acquisition of 24-hour Sensor output signal
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
Fluctuation is defined as a change of 25% or more from the mean Sensor output over 24 hours for each participant.
Full Information
NCT ID
NCT01263535
First Posted
December 2, 2010
Last Updated
August 27, 2012
Sponsor
Sensimed AG
Collaborators
University Hospital, Geneva
1. Study Identification
Unique Protocol Identification Number
NCT01263535
Brief Title
Use of an Ocular Telemetry Sensor in Tafluprost Treated Patients
Official Title
Circadian Continuous Intraocular Pressure Monitoring With SENSIMED Triggerfish® Ocular Telemetry Sensor in Patients on Tafluprost Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Terminated
Study Start Date
September 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sensimed AG
Collaborators
University Hospital, Geneva
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SENSIMED Triggerfish
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
SENSIMED Triggerfish
Intervention Description
Contact lens-based device for the continuous recording of IOP fluctuations, with a portable recording system
Primary Outcome Measure Information:
Title
Acquisition of 24-hour Sensor output signal
Description
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.
Time Frame
After 24-hour continuous recording
Secondary Outcome Measure Information:
Title
Possible IOP fluctuation
Description
Fluctuation is defined as a change of 25% or more from the mean Sensor output over 24 hours for each participant.
Time Frame
After 24-hour recording with study device
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University Hospital Geneva
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Use of an Ocular Telemetry Sensor in Tafluprost Treated Patients
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