Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

SENSIMED Triggerfish Sensor Sizes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01972997
Recruitment Status : Completed
First Posted : October 31, 2013
Last Update Posted : November 17, 2015
Sponsor:
Information provided by (Responsible Party):
Sensimed AG

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Device: SENSIMED Triggerfish Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: 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
Study Start Date : July 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

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



Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01972997


Locations
Layout table for location information
Spain
Hospital Clinico San Carlos
Madrid, Spain
Sponsors and Collaborators
Sensimed AG

Layout table for additonal information
Responsible Party: Sensimed AG
ClinicalTrials.gov Identifier: NCT01972997     History of Changes
Other Study ID Numbers: TF-1220
First Posted: October 31, 2013    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015