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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

March 18, 2011
November 8, 2011
January 2011
November 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01319617 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
SENSIMED Triggerfish Safety and Tolerability
Evaluation of SENSIMED Triggerfish Safety and Tolerability in Glaucoma Patients and Glaucoma Suspects

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.
Not Provided
Interventional
Not Provided
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Glaucoma
Device: SENSIMED Triggerfish
Soft contact lens-based device intended for continuous recording of relative changes in IOP
Experimental: SENSIMED Triggerfish
Intervention: Device: SENSIMED Triggerfish
Mansouri K, Liu JH, Weinreb RN, Tafreshi A, Medeiros FA. Analysis of continuous 24-hour intraocular pressure patterns in glaucoma. Invest Ophthalmol Vis Sci. 2012 Dec 13;53(13):8050-6. doi: 10.1167/iovs.12-10569.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01319617
10/05
No
Sensimed AG
Sensimed AG
Not Provided
Principal Investigator: Felipe Medeiros, MD, PhD University of California, San Diego
Sensimed AG
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP