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SENSIMED Triggerfish Discomfort During IOP Monitoring (09/02)

This study has been completed.
Sponsor:
Information provided by:
Sensimed AG
ClinicalTrials.gov Identifier:
NCT00966108
First received: August 24, 2009
Last updated: February 3, 2010
Last verified: February 2010
  Purpose

Evaluation of the wearing discomfort (safety and tolerability) involved during IOP monitoring with the SENISMED Triggerfish, a sensor embedded in a telemetric contact lens


Condition Intervention
Safety and Tolerability of SENSIMED Triggerfish in Glaucoma Patients
Device: SENSIMED Triggerfish

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of SENSIMED Triggerfish for 24 Hour IOP Monitoring in Healthy Subjects and Glaucoma Patients

Resource links provided by NLM:


Further study details as provided by Sensimed AG:

Primary Outcome Measures:
  • ocular discomfort on a visual analogue scale [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: August 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Healthy subjects Device: SENSIMED Triggerfish
Ocular Telemetry Sensor for IOP monitoring
Glaucoma patients Device: SENSIMED Triggerfish
Ocular Telemetry Sensor for IOP monitoring

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Healthy subjects and glaucoma patients

Criteria

Inclusion Criteria:

  • Patient is able to comply with the study procedure
  • Patient is 18-80 years old
  • Healthy subject or glaucoma patient
  • Patient has consented to be in the trial and signed informed consent is available before any study related procedures are carried out
  • Cylinder refraction of no more than +/- 2 diopters in the study eye
  • Visual acuity of 20/80 or better in the study eye
  • Ability of subject to understand the character and individual consequences of the study
  • For women with childbearing potential, adequate contraception

Exclusion Criteria:

  • Subjects wearing contact lenses within the last two years
  • Subjects with contraindications for wearing contact lenses
  • History of refractive surgery
  • History of intraocular surgery in the last three months
  • Severe dry eye syndrome
  • Keratoconus or other corneal abnormalities
  • Conjunctival or intraocular inflammation
  • Pregnancy and lactation
  • Simultaneous participation in other clinical trials
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00966108

Locations
Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Rheinland-Pfalz, Germany, 55131
Sponsors and Collaborators
Sensimed AG
Investigators
Principal Investigator: Norbert Pfeiffer, Prof. Dr. med. Universitätsmedizin Mainz
  More Information

No publications provided

Responsible Party: Prof. Dr. med. Norbert Pfeiffer, Universitätsmedizin der Johannes Gutenberg-Universität Mainz
ClinicalTrials.gov Identifier: NCT00966108     History of Changes
Other Study ID Numbers: 09/02
Study First Received: August 24, 2009
Last Updated: February 3, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Glaucoma
Eye Diseases
Ocular Hypertension

ClinicalTrials.gov processed this record on November 20, 2014