SENSIMED Triggerfish Sensor Sizes

November 16, 2015 updated by: Sensimed AG

A Single-center, Randomized, Double-blinded, Prospective Study to Assess the Changes in the 24-hour IOP (Intraocular Pressure) Pattern in Relation to SENSIMED Triggerfish® Sensor Sizes in Healthy Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain
        • Hospital Clinico San Carlos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SENSIMED Triggerfish
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The effect of the sensor lens size on IOP patterns as recorded by TF (SENSIMED Triggerfish) as compared to the recommended sensor lens fit
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sensimed AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

July 26, 2013

First Submitted That Met QC Criteria

October 24, 2013

First Posted (Estimate)

October 31, 2013

Study Record Updates

Last Update Posted (Estimate)

November 17, 2015

Last Update Submitted That Met QC Criteria

November 16, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • TF-1220

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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