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

NCT01906502 | Completed

• 1 other identifier: TF-1217
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Healthy Subject

Outcome Measures

Primary Outcomes (1)

• The 24-hour IOP pattern recorded with Sensimed Triggerfish (TF) in healthy subjects, aged between 40 and 80 years Secondary

  24-hour

Secondary Outcomes (4)

• Diurnal and nocturnal IOP patterns in healthy subjects

  24 hours

• Assessment of corneal biomechanical properties in healthy population (if available)

  24 hours

• Relationship between the 24-hour IOP pattern monitored by TF and the 24-hour blood pressure pattern in healthy subjects (if available)

  24 hours

• Assessment of Safety and tolerability through adverse events

  6 months

Study Arms (1)

Device

EXPERIMENTAL

Portable device that monitors the 24-hour IOP pattern by a wireless contact lens sensor (CLS) placed on the eye that sends its signals via an antenna around the orbital cavity to a recorder. Upon completion, the recording can be transmitted to a computer for read-out and visualization.

Device: Sensimed Triggerfish

Interventions

Sensimed Triggerfish DEVICE

Device

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sensimed AG: lead

Study Sites (5)

Meir Medical Center

Kfar Saba, Israel

Location

The Western Galilee Hospital in Naharya

Naharya, Israel

Location

Rabin Medical Center

Petah Tikva, Israel

Location

Kaplan Medical Center

Rehovot, Israel

Location

Sourasky Medical Center

Tel Aviv, Israel

Location

Study Officials

• Moshe Lusky, MD

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2013
• First Posted: July 24, 2013
• Study Start: July 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: August 26, 2014

Record last verified: 2014-08

Locations

IL (5)