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SENSIMED Triggerfish Safety and Tolerability

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sensimed AG
ClinicalTrials.gov Identifier:
NCT01319617
First received: March 18, 2011
Last updated: November 8, 2011
Last verified: November 2011
History of Changes
  Purpose

The purpose of this investigation is to study the safety and tolerability of SENSIMED Triggerfish, a soft contact lens-based device intended to continuously record relative changes in intraocular pressure (IOP). The investigation enrols glaucoma patients and glaucoma suspects. All subjects receive two 24-hour recording sessions with the device in an ambulatory setting and at weekly interval. The level of discomfort in the study eye after 24 hours and side effects are the main endpoints of the investigation.


Condition Intervention
Glaucoma
 Device: SENSIMED Triggerfish

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of SENSIMED Triggerfish Safety and Tolerability in Glaucoma Patients and Glaucoma Suspects

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by Sensimed AG:

Primary Outcome Measures:
  • Ocular discomfort [ Time Frame: After 24 hours of device wear ] [ Designated as safety issue: Yes ]
    Ocular discomfort in the study eye is assessed using a visual analog scale after wearing the device for 24 hours at two occasions separated by one week.


Enrollment: 40
Study Start Date: January 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SENSIMED Triggerfish Device: SENSIMED Triggerfish
Soft contact lens-based device intended for continuous recording of relative changes in IOP

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is able to comply with the study procedures
  • Subject is 18-80 years old
  • Glaucoma patient, with glaucomatous optic neuropathy based on clinical assessment of stereoscopic optic disc photographs and/or repeatable abnormal standard automated perimetry (SAP) visual fields at baseline, defined as a pattern standard deviation with P<0.05 or a glaucoma Hemifield test "outside normal limits
  • Glaucoma suspect, with suspicious optic disc appearance (as determined by subjective assessment on the baseline visit) or elevated IOP (>21 mmHg) but normal and reliable SAP visual fields at baseline
  • Subject has consented to be in the trial and signed informed consent is available before any study related procedures are carried out
  • Visual acuity of 20/200 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 with contraindications for wearing contact lenses
  • Severe dry eye syndrome
  • Keratoconus or other corneal abnormality
  • Conjunctival or intraocular inflammation
  • Eye surgery prior to and throughout the study, except prior uncomplicated cataract surgery a minimum of 3 months prior to the investigation
  • Full frame metal glasses during SENSIMED Triggerfish® recording
  • Known hypersensitivity to silicone, plaster or ocular anesthesia
  • Pregnancy and lactation
  • Simultaneous participation in other clinical studies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01319617

Locations
United States, California
University of California San Diego
San Diego, California, United States, 92093-0946
Sponsors and Collaborators
Sensimed AG
Investigators
Principal Investigator: Felipe Medeiros, MD, PhD University of California, San Diego
  More Information

No publications provided by Sensimed AG

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sensimed AG
ClinicalTrials.gov Identifier: NCT01319617     History of Changes
Other Study ID Numbers: 10/05
Study First Received: March 18, 2011
Last Updated: November 8, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013