Use of an Ocular Telemetry Sensor in Tafluprost Treated Patients

Glaucoma Clinical Trial

Official title:

Circadian Continuous Intraocular Pressure Monitoring With SENSIMED Triggerfish® Ocular Telemetry Sensor in Patients on Tafluprost Treatment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01263535
• Other study ID #: 09/06
• Status: Terminated
• Phase: Phase 4
• First received: December 2, 2010
• Last updated: August 27, 2012
• Start date: September 2010
• Est. completion date: May 2012

Study information

• Verified date: August 2012
• Source: Sensimed AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swiss agency for therapeutic products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: May 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• SENSIMED Triggerfish
Contact lens-based device for the continuous recording of IOP fluctuations, with a portable recording system

Locations

Country	Name	City	State
Switzerland	University Hospital Geneva	Geneva

Sponsors (2)

Lead Sponsor	Collaborator
Sensimed AG	University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	After 24-hour continuous recording	No
Secondary	Possible IOP fluctuation	Fluctuation is defined as a change of 25% or more from the mean Sensor output over 24 hours for each participant.	After 24-hour recording with study device	No