NCT01938287

Brief Summary

This study investigates the effect of eye opening/closure on the quality of IOP (intraocular pressure) related patterns recorded with SENSIMED Triggerfish. Each subject receives 2 24-hour recording sessions, one with the recorded eye open and the other with the eye closed,using an ophthalmic patch.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 10, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

November 17, 2015

Status Verified

November 1, 2015

Enrollment Period

2 months

First QC Date

July 26, 2013

Last Update Submit

November 16, 2015

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

  • The difference between start and end TF (SENSIMED Triggerfish) in a closed eye as compared to the difference between start to end TF in an open eye

    TF will be installed on subjects' eyes for 24 hours in two sessions. In one session the eye will remain open (except during sleep) while in the other session the eye will be closed using an ophthalmic patch throughout the 24 hours. For both sessions, the initial TF output value in millivolt equivalent will be subtracted from the final output value to yield the difference from start to end. The difference obtained in the session with closed eye will be divided by that of the session with open eye (ratio).

    24 hours

Study Arms (1)

SENSIMED Triggerfish

EXPERIMENTAL
Device: SENSIMED Triggerfish

Interventions

SENSIMED TriggerfishDEVICE
SENSIMED Triggerfish

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy subject without previous ophthalmic medical history (except from indication for glasses)
  • Aged ≥18 years, of either sex
  • Have given written informed consent, prior to any investigational procedures

You may not qualify if:

  • Patients with allergy to corneal anesthetic
  • Patients with contraindications for silicone contact lens wear
  • Patients not able to understand the character and individual consequences of the investigation
  • Participation in other clinical research within the last 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HUG, Department of Ophthalmology, Glaucoma Sector

Geneva, Switzerland

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2013

First Posted

September 10, 2013

Study Start

July 1, 2013

Primary Completion

September 1, 2013

Study Completion

February 1, 2014

Last Updated

November 17, 2015

Record last verified: 2015-11

Locations

CH(1)