NCT01972997

Brief Summary

This is a study investigating the effect of various SENSIMED Triggerfish sensor lens sizes on the recorded IOP related patterns in 10 healthy volunteers. Each volunteers receives 4 24-hours sessions of pattern recording on one selected eye (study eye). Each of the sensor lens sizes is placed on the eye in the different sessions. Subjects visit the study site for installation and removal of the device and accompanying exams, but remain ambulatory during the recording.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_4 healthy-volunteers

Timeline
Completed

Started Jul 2013

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

Click on a node to explore related trials.

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
3 months until next milestone

First Posted

Study publicly available on registry

October 31, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

November 17, 2015

Status Verified

November 1, 2015

Enrollment Period

8 months

First QC Date

July 26, 2013

Last Update Submit

November 16, 2015

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • The effect of the sensor lens size on IOP patterns as recorded by TF (SENSIMED Triggerfish) as compared to the recommended sensor lens fit

    24 hours

Study Arms (1)

SENSIMED Triggerfish

EXPERIMENTAL

There is only 1 arm in the study. SENSIMED Trigerfish lens sensors with different base curves are placed on subjects in random and double-blinded manner in sequential sessions.

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 ocular disease
  • Aged ≥ 18 years, of either sex
  • Central corneal radius (flat meridian) between 7.75 mm and 8.25 mm in at least one eye
  • 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
  • Severe dry eye 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
  • Any other contra-indication listed in the TF user manual

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinico San Carlos

Madrid, Spain

Location

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2013

First Posted

October 31, 2013

Study Start

July 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

November 17, 2015

Record last verified: 2015-11

Locations

ES(1)