SENSIMED Triggerfish Safety and Tolerability

• Sponsor: Sensimed AG (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01319617
• Collaborator: (none)
• Enrollment: 41
• Location: 1
• Arm: 1
• Duration (Months): 10
• Patients Per Site Per Month: 4.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Device: SENSIMED Triggerfish	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 41 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Evaluation of SENSIMED Triggerfish Safety and Tolerability in Glaucoma Patients and Glaucoma Suspects
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SENSIMED Triggerfish	Device: SENSIMED Triggerfish; Soft contact lens-based device intended for continuous recording of relative changes in IOP

Outcome Measures

Primary Outcome Measures

1. Ocular Discomfort [After 24 hours of device wear]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sensimed AG
• ClinicalTrials.gov Identifier: NCT01319617
• Other Study ID Numbers: 10/05
• First Posted: Mar 21, 2011
• Last Update Posted: Sep 9, 2013
• Last Verified: Sep 1, 2013

• Additional relevant MeSH terms: Glaucoma

Study Results

Participant Flow

Recruitment Details	Recruitment from medical clinic from January to September 2011

Arm/Group Title	SENSIMED Triggerfish
Arm/Group Description	SENSIMED Triggerfish is a device containing a soft silicone contact lens sensor detecting ocular dimensional changes related to IOP through an integrated strain gauge. The device energy and data transfer between the contact lens sensor and the external recording and data storage unit is done using telemetry. All study subjects received SENSIMED Triggerfish on one eye for 24 hours at two occasions in ambulatory mode, without restriction of activities apart from those contraindicated by the device instructions for use. The device was installed and removed by the study staff during visits to the study center.
Period Title: Overall Study
STARTED	41
COMPLETED	40
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	SENSIMED Triggerfish
Arm/Group Description	SENSIMED Triggerfish is a device containing a soft silicone contact lens sensor detecting ocular dimensional changes related to IOP through an integrated strain gauge. The device energy and data transfer between the contact lens sensor and the external recording and data storage unit is done using telemetry. All study subjects received SENSIMED Triggerfish on one eye for 24 hours at two occasions in ambulatory mode, without restriction of activities apart from those contraindicated by the device instructions for use. The device was installed and removed by the study staff during visits to the study center
Overall Participants	41
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	28 68.3%
>=65 years	13 31.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.6 (16.5)
Sex: Female, Male (Count of Participants)
Female	16 39%
Male	25 61%
Region of Enrollment (participants) [Number]
United States	41 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SENSIMED Triggerfish
Arm/Group Description	SENSIMED Triggerfish is a device containing a soft silicone contact lens sensor detecting ocular dimensional changes related to IOP through an integrated strain gauge. The device energy and data transfer between the contact lens sensor and the external recording and data storage unit is done using telemetry. All study subjects received SENSIMED Triggerfish on one eye for 24 hours at two occasions in ambulatory mode, without restriction of activities apart from those contraindicated by the device instructions for use. The device was installed and removed by the study staff during visits to the study center
Measure Participants	40
Mean (Standard Deviation) [mm]	25.5 (18.6)

Adverse Events

Arm/Group Title	SENSIMED Triggerfish
Arm/Group Description	SENSIMED Triggerfish is a device containing a soft silicone contact lens sensor detecting ocular dimensional changes related to IOP through an integrated strain gauge. The device energy and data transfer between the contact lens sensor and the external recording and data storage unit is done using telemetry. All study subjects received SENSIMED Triggerfish on one eye for 24 hours at two occasions in ambulatory mode, without restriction of activities apart from those contraindicated by the device instructions for use. The device was installed and removed by the study staff during visits to the study center
All Cause Mortality
	SENSIMED Triggerfish
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	SENSIMED Triggerfish
	Affected / at Risk (%)	# Events
Total	0/41 (0%)
Other (Not Including Serious) Adverse Events
	SENSIMED Triggerfish
	Affected / at Risk (%)	# Events
Total	39/41 (95.1%)
Eye disorders
conjunctival edema	1/41 (2.4%)	1
device intolerance	1/41 (2.4%)	1
eye irritation	3/41 (7.3%)	3
eye pressure mark	13/41 (31.7%)	17
eye pruritus	3/41 (7.3%)	3
ocular discomfort	1/41 (2.4%)	2
ocular hyperemia	32/41 (78%)	56
punctate keratitis	6/41 (14.6%)	6
vision blurred	33/41 (80.5%)	60

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.