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SENSIMED Triggerfish Safety and Tolerability

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SENSIMED Triggerfish
Sponsored by
Sensimed AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glaucoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California San Diego

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SENSIMED Triggerfish

Arm Description

Outcomes

Primary Outcome Measures

Ocular Discomfort
Ocular discomfort in the study eye is reported by patients on a 100-mm visual analog scale (left end 0 mm, no discomfort; right end 100 mm, very severe discomfort) as the distance from the left end to the patient's mark after wearing the device for 24 hours at two occasions separated by one week. Values for both sessions were averaged.

Secondary Outcome Measures

Full Information

First Posted
March 18, 2011
Last Updated
September 4, 2013
Sponsor
Sensimed AG
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1. Study Identification

Unique Protocol Identification Number
NCT01319617
Brief Title
SENSIMED Triggerfish Safety and Tolerability
Official Title
Evaluation of SENSIMED Triggerfish Safety and Tolerability in Glaucoma Patients and Glaucoma Suspects
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sensimed AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SENSIMED Triggerfish
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
SENSIMED Triggerfish
Intervention Description
Soft contact lens-based device intended for continuous recording of relative changes in IOP
Primary Outcome Measure Information:
Title
Ocular Discomfort
Description
Ocular discomfort in the study eye is reported by patients on a 100-mm visual analog scale (left end 0 mm, no discomfort; right end 100 mm, very severe discomfort) as the distance from the left end to the patient's mark after wearing the device for 24 hours at two occasions separated by one week. Values for both sessions were averaged.
Time Frame
After 24 hours of device wear

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe Medeiros, MD, PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093-0946
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23229696
Citation
Mansouri K, Medeiros FA, Tafreshi A, Weinreb RN. Continuous 24-hour monitoring of intraocular pressure patterns with a contact lens sensor: safety, tolerability, and reproducibility in patients with glaucoma. Arch Ophthalmol. 2012 Dec;130(12):1534-9. doi: 10.1001/jamaophthalmol.2013.1350.
Results Reference
derived
PubMed Identifier
23139273
Citation
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.
Results Reference
derived
PubMed Identifier
22892888
Citation
Mansouri K, Medeiros FA, Tafreshi A, Weinreb RN. Continuous 24-hour monitoring of intraocular pressure patterns with a contact lens sensor: safety, tolerability, and reproducibility in patients with glaucoma. Arch Ophthalmol. 2012 Dec;130(12):1534-9. doi: 10.1001/archophthalmol.2012.2280.
Results Reference
derived

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SENSIMED Triggerfish Safety and Tolerability

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