SENSIMED Triggerfish Discomfort During IOP Monitoring

Safety and Tolerability of SENSIMED Triggerfish in Glaucoma Patients Clinical Trial

— 09/02  

Official title:

Evaluation of SENSIMED Triggerfish for 24 Hour IOP Monitoring in Healthy Subjects and Glaucoma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00966108
• Other study ID #: 09/02
• Status: Completed
• Phase: N/A
• First received: August 24, 2009
• Last updated: February 3, 2010
• Start date: August 2009
• Est. completion date: January 2010

Study information

• Verified date: February 2010
• Source: Sensimed AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

Evaluation of the wearing discomfort (safety and tolerability) involved during IOP monitoring with the SENISMED Triggerfish, a sensor embedded in a telemetric contact lens

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patient is able to comply with the study procedure

• Patient is 18-80 years old

• Healthy subject or glaucoma patient

• Patient has consented to be in the trial and signed informed consent is available before any study related procedures are carried out

• Cylinder refraction of no more than +/- 2 diopters in the study eye

• Visual acuity of 20/80 or better in the study eye

• Ability of subject to understand the character and individual consequences of the study

• For women with childbearing potential, adequate contraception

Exclusion Criteria:

• Subjects wearing contact lenses within the last two years

• Subjects with contraindications for wearing contact lenses

• History of refractive surgery

• History of intraocular surgery in the last three months

• Severe dry eye syndrome

• Keratoconus or other corneal abnormalities

• Conjunctival or intraocular inflammation

• Pregnancy and lactation

• Simultaneous participation in other clinical trials

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma
• Safety and Tolerability of SENSIMED Triggerfish in Glaucoma Patients

Intervention

Device:
• SENSIMED Triggerfish
Ocular Telemetry Sensor for IOP monitoring

Locations

Country	Name	City	State
Germany	Universitätsmedizin der Johannes Gutenberg-Universität Mainz	Mainz	Rheinland-Pfalz

Sponsors (1)

Lead Sponsor	Collaborator
Sensimed AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ocular discomfort on a visual analogue scale		24 hours	Yes