Use of an Ocular Telemetry Sensor in Tafluprost Treated Patients

Sensimed

Status and phase: Terminated; Phase 4

Conditions: Glaucoma

Treatments: Device: SENSIMED Triggerfish

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01263535

09/06

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

SENSIMED Triggerfish

Experimental group

Treatment:

Device: SENSIMED Triggerfish