24-hour IOP Pattern With SENSIMED Triggerfish® in a Healthy Population

Healthy Subject Clinical Trial

Official title:

A Prospective, Open Label Study to Assess the 24-hour IOP Pattern Recorded With SENSIMED Triggerfish® in a Healthy Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01906502
• Other study ID #: TF-1217
• Status: Completed
• Phase: N/A
• First received: July 17, 2013
• Last updated: August 25, 2014
• Start date: July 2013
• Est. completion date: April 2014

Study information

• Verified date: August 2014
• Source: Sensimed AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

A database (Snapfish) has been generated at Sensimed compiling all data acquired up to now on healthy volunteers and patients with glaucoma. However, healthy subjects were much younger than glaucoma patients. Additionally, the number of glaucoma patients in Snapfish database was almost twice higher than the number of healthy subjects. As it is generally accepted that intra ocular pressure (IOP) in the aging population is higher than IOP in young adults it is of interest to evaluate the 24-hour IOP pattern of older healthy subjects. Furthermore, improving our knowledge of the "healthy" 24-hour IOP pattern in comparison to glaucoma profiles would be beneficial for management of glaucoma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Subject of Caucasian origin

• Healthy subject without previous ocular disease

• Aged between 40 and 80 years, of either sex

• Not more than 6 diopters spherical equivalent in the study eye

• Having given written informed consent, prior to any investigational procedures

Exclusion Criteria:

• Corneal or conjunctival abnormality precluding contact lens adaptation

• Previous refractive surgery

• Occludable or closed iridocorneal angle

• Sleep apnea syndrome

• Subjects with allergy to corneal anesthetic

• Subjects with contraindications for silicone contact lens wear

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

• Participation in other clinical research within the last 4 weeks

Study Design

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

Related Conditions & MeSH terms

• Healthy Subject

Intervention

Device:
• Sensimed Triggerfish

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba
Israel	The Western Galilee Hospital in Naharya	Naharya
Israel	Rabin Medical Center	Petach Tikva
Israel	Kaplan Medical Center	Rehovot
Israel	Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Sensimed AG

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The 24-hour IOP pattern recorded with Sensimed Triggerfish (TF) in healthy subjects, aged between 40 and 80 years Secondary		24-hour	No
Secondary	Diurnal and nocturnal IOP patterns in healthy subjects		24 hours	No
Secondary	Assessment of corneal biomechanical properties in healthy population (if available)		24 hours	No
Secondary	Relationship between the 24-hour IOP pattern monitored by TF and the 24-hour blood pressure pattern in healthy subjects (if available)		24 hours	No
Secondary	Assessment of Safety and tolerability through adverse events		6 months	Yes