Use of an Ocular Telemetry Sensor in Tafluprost Treated Patients

Phase 4

Terminated

• Conditions: Glaucoma
• Interventions: Device: SENSIMED Triggerfish

• Registration Number: NCT01263535
• Lead Sponsor: Sensimed AG

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 available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-12-02
• Study First Submitted QC: 2010-12-17
• Study First Posted: 2010-12-20
• Primary Completion: 2012-04
• Study Completion: 2012-05
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-27
• Last Update Posted: 2012-08-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SENSIMED Triggerfish	SENSIMED Triggerfish	-

Primary Outcome Measures

Name	Time	Method
Acquisition of 24-hour Sensor output signal	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

Name	Time	Method
Possible IOP fluctuation	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.

Trial Locations

Locations (1)

University Hospital Geneva; 🇨🇭 Geneva, Switzerland