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CompletedNCT01972997Updated Nov 17, 2015

SENSIMED Triggerfish Sensor Sizes

A Phase 4 interventional study of SENSIMED Triggerfish in Healthy Volunteers, sponsored by Sensimed AG. Completed at 1 site in Spain. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-11-17.

Sponsored by Sensimed AG · Phase 4, Interventional, and Diagnostic

Phase
Phase 4
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

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Conditions studied

  • Healthy Volunteers
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In context

Lead sponsor

Sensimed AG is the lead sponsor of 28 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
14 participants (actual)

Study arms

  • 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

Interventions

  • DeviceSENSIMED Triggerfish
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What researchers measure

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

    Time frame: 24 hours

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Study locations

1 site
  • Hospital Clinico San Carlos
    Madrid, Spain
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01972997
Lead sponsor
Sensimed AG
Responsible party
Sponsor
First posted
Oct 31, 2013
Start date
Jul 2013
Primary completion
Mar 2014
Completion
Mar 2014
Last update
Nov 17, 2015
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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