Use of an Ocular Telemetry Sensor in Tafluprost Treated Patients

NCT01263535 | Terminated Phase 4

• 1 other identifier: 09/06
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Possible IOP fluctuation

  After 24-hour recording with study device

Study Arms (1)

SENSIMED Triggerfish

EXPERIMENTAL

Device: SENSIMED Triggerfish

Interventions

SENSIMED Triggerfish DEVICE

Contact lens-based device for the continuous recording of IOP fluctuations, with a portable recording system

SENSIMED Triggerfish

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sensimed AG: lead
• University Hospital, Geneva: collaborator

Study Sites (1)

University Hospital Geneva

Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 2, 2010
• First Posted: December 20, 2010
• Study Start: September 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: May 1, 2012
• Last Updated: August 28, 2012

Record last verified: 2012-08

Locations

CH (1)