SENSIMED Triggerfish

Glaucoma Clinical Trial

Official title:

Randomized Clinical Investigation to Assess the Efficacy of SENSIMED Triggerfish Continuous IOP Monitoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01319604
• Other study ID #: 10/01
• Status: Completed
• Phase: N/A
• First received: March 18, 2011
• Last updated: August 7, 2012
• Start date: March 2011
• 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

The purpose of the investigation is to investigate the relationship between the study device output and tonometric assessments.

Description:

60 subjects will be enrolled in total. Enrolled patients will be randomized into one of 8 device groups of 6 subjects each or into the control group containing 12 subjects. Patients in the device arm will receive one session of 3-to 24-hour continuous IOP monitoring with SENSIMED Triggerfish®. SENSIMED Triggerfish® monitoring will begin at 18h ± 2 hours for all patients. SENSIMED Triggerfish® will be installed randomly on right or left eyes. During SENSIMED Triggerfish® monitoring on one eye, GAT and/or Perkins IOP measurements will be taken in the fellow eye every 3 hours. Outside this time they will receive GAT and/or IOP measurements every 3 hours in both eyes until the end of the 24-hours period. Patients in the control group will receive GAT and/or ICare PRO IOP measurements every 3 hours for 24 hours in both eyes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Signed informed consent for the investigation

• Confirmed diagnosis of primary open angle glaucoma or normal tension glaucoma of similar degree in both eyes

• Age 18-85

• Stable anti-glaucomatous therapy 4 weeks before and throughout the investigation

Exclusion Criteria:

• Patients not able to understand the character and individual consequences of the investigation

• Patients with contraindications for silicone contact lens wear

• Wear of full frame metallic glasses during SENSIMED Triggerfish® monitoring

• Diagnosis of pseudoexfoliation syndrome / pseudoexfoliative glaucoma and of pigment dispersion syndrome / pigmentary glaucoma

• Severe dry eye

• Patients who have had ocular surgery within the last 3 months

• Corneal or conjunctival abnormality or irregularity hindering correct contact lens adaptation

• Allergy to corneal anaesthesia

• Simultaneous participation in other clinical research

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• SENSIMED Triggerfish
Soft contact lens-based device for the continuous monitoring of IOP fluctuations
• Tonometer
Tonometric assessment of IOP

Locations

Country	Name	City	State
Belgium	University Hospital Leuven	Leuven
Denmark	University Hospital Glostrup	Glostrup
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Universitari i Politècnic la Fe	Valencia
Switzerland	Inselspital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Sensimed AG

Countries where clinical trial is conducted

Belgium,  Denmark,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship between study device signal and tonometer reading		during 24 hours of study device wear	No