Efficacy of 24-hour Intraocular Pressure Fluctuation Recording With the SENSIMED Triggerfish Contact Lens Sensor

• Sponsor: Sensimed AG (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01390779
• Collaborator: (none)
• Enrollment: 33
• Location: 1
• Arm: 1
• Duration (Months): 10
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief Summary

The objectives of this study are to assess the safety and effectiveness of the SENSIMED Triggerfish® (TF) device in continuous recording of relative fluctuation in intraocular pressure (IOP). Safety will be assessed by recording of AEs during the 24 hours of continuous TF recording.

TF efficacy will be evaluated by demonstrating TF ability to detect:

1. The known phenomenon of increase in IOP when moving from waking state to going to bed, as reflected in pneumotonometer measurements

2. Ocular Pulse frequency relative to direct measurement of Heart Rate (HR).

A screening visit and one 24-hour IOP fluctuation recording session are planned for each patient. IOP fluctuation recording sessions will be carried out in a sleep unit. An ophthalmological examination of the eyes will be done at screening and prior to and following the device recording.

Condition or Disease	Intervention/Treatment	Phase
Primary Open Angle Glaucoma; Healthy Subjects	Device: SENSIMED Triggerfish	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Efficacy of 24-hour Intraocular Pressure Fluctuation Recording With the SENSIMED Triggerfish Contact Lens Sensor
• Study Start Date: Jul 1, 2011
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SENSIMED Triggerfish All subjects enrolled in the trial were housed in a sleep laboratory for 24 hours, during which they underwent SENSIMED Triggerfish recording on one randomly selected eye.	Device: SENSIMED Triggerfish; Contact lens-based device intended to continuously record the timing of relative changes in IOP for up to 24 hours

Outcome Measures

Primary Outcome Measures

1. SENSIMED Triggerfish Efficacy [from 1 hour before sleep to 1 hour after sleep]

   Investigate the device's capacity to detect changes in IOP from wake to sleep, defined as a significantly positive slope on the SENSIMED Triggerfish recording (obtained on one eye in each subject), based on the established phenomenon that IOP increases from waking to sleep hours. The IOP from wake to sleep was measured in the eye contralateral to that of SENSIMED Triggerfish using pneumatonomtery. Subjects were included in the primary analysis if a difference in IOP of at least 3 mmHg was detected from wake to sleep. One subject was excluded from the analysis due to the absence of a 3-mmHg difference in IOP from wake to sleep. Two subjects were excluded since they had less than 80% of expected SENSIMED Triggerfish data. One subject was excluded from the analysis due to an invalid SENSIMED Triggerfish recording.

2. SENSIMED Triggerfish Efficacy [in selected 30-second SENSIMED Triggerfish recording intervals during sleep]

   Device's ability to detect ocular pulse frequency concurrent to heart rate, defined as the number of SENSIMED Triggerfish recording intervals showing oscillation at a frequency matching that of heart rate +/- 15%. In absence of eye blinks during sleep, an oscillating pattern is recorded. The frequency of oscillation was determined by independent reviewers for selected SENSIMED Triggerfish 30-second recording intervals for which simultaneous or close to simultaneous heart rate data was recorded. Intervals for which the oscillation frequency on SENSIMED Triggerfish pattern matched heart rate +/- 15% (tolerance due to noise caused by eye and lid movements) were considered accurate. The percentage of accurate intervals was calculated and expected to be at least 75%.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Signed informed consent for the investigation

• Diagnosis of primary open angle glaucoma (POAG), including normal tension glaucoma, or healthy subjects, including subjects with ocular hypertension for whom no evidence or suspicion of structural or functional glaucomatous damage exists

• No anti-glaucomatous drug treatment or washed-out for 4 weeks

• IOP symmetry of +/- 3 mmHg between fellow eyes

• Age 18-80 years

• Not more than 4 diopters spherical equivalent on both eyes

• Not more than 2 diopters cylinder equivalent on both eyes

Exclusion Criteria:

• Patients who have had ocular surgery within the last 3 months.

• Corneal or conjunctival abnormality hindering contact lens adaptation

• Wear of full frame metallic glasses during SENSIMED Triggerfish® monitoring

• Severe dry eye

• Secondary forms of open angle glaucoma (OAG)

• Allergy to corneal anesthetic

• Patients with contraindications for silicone contact lens wear

• Patients not able to understand the character and individual consequences of the investigation

• Simultaneous participation in other clinical research

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSD	San Diego	California	United States	92093-0946

Sponsors and Collaborators

• Sensimed AG

Investigators

• Principal Investigator: John HK Liu, PhD, UCSD

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sensimed AG
• ClinicalTrials.gov Identifier: NCT01390779
• Other Study ID Numbers: 10/09
• First Posted: Jul 11, 2011
• Last Update Posted: Jan 20, 2014
• Last Verified: Dec 1, 2013

• Additional relevant MeSH terms: Glaucoma, Open-Angle

Study Results

Participant Flow

Recruitment Details	Recruitment from July 2011 to May 2012, from medical clinic and investigator's patient database.
Pre-assignment Detail	Regular sleep cycle in the week preceding the study.

Arm/Group Title	SENSIMED Triggerfish
Arm/Group Description	All subjects enrolled in the trial were housed in a sleep laboratory for 24 hours, during which they underwent SENSIMED Triggerfish recording on one randomly selected eye. Parallel IOP measurements were taken using pneumatonometry on the eye contralateral to the SENSIMED Triggerfish eye before and after sleep onset. During sleep heart rate measurements were collected at specified time points.
Period Title: Overall Study
STARTED	33
COMPLETED	32
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	SENSIMED Triggerfish
Arm/Group Description
Overall Participants	33
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	31 93.9%
>=65 years	2 6.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35 (14.4)
Sex: Female, Male (Count of Participants)
Female	16 48.5%
Male	17 51.5%
Region of Enrollment (participants) [Number]
United States	33 100%

Outcome Measures

1. Primary Outcome

Title	SENSIMED Triggerfish Efficacy
Description	Investigate the device's capacity to detect changes in IOP from wake to sleep, defined as a significantly positive slope on the SENSIMED Triggerfish recording (obtained on one eye in each subject), based on the established phenomenon that IOP increases from waking to sleep hours. The IOP from wake to sleep was measured in the eye contralateral to that of SENSIMED Triggerfish using pneumatonomtery. Subjects were included in the primary analysis if a difference in IOP of at least 3 mmHg was detected from wake to sleep. One subject was excluded from the analysis due to the absence of a 3-mmHg difference in IOP from wake to sleep. Two subjects were excluded since they had less than 80% of expected SENSIMED Triggerfish data. One subject was excluded from the analysis due to an invalid SENSIMED Triggerfish recording.
Time Frame	from 1 hour before sleep to 1 hour after sleep

Outcome Measure Data

Analysis Population Description

Subjects were included in this analysis if the difference in IOP from wake to sleep was at least 3 mmHg, as determined using pneumatonometry on the eye contralateral to that of SENSIMED Triggerfish, and if the SENSIMED Triggerfish recording contained at least 80% of the expected data points.

Arm/Group Title	SENSIMED Triggerfish
Arm/Group Description
Measure Participants	29
Mean (Standard Deviation) [mV/h]	56.9 (40.5)

2. Primary Outcome

Title	SENSIMED Triggerfish Efficacy
Description	Device's ability to detect ocular pulse frequency concurrent to heart rate, defined as the number of SENSIMED Triggerfish recording intervals showing oscillation at a frequency matching that of heart rate +/- 15%. In absence of eye blinks during sleep, an oscillating pattern is recorded. The frequency of oscillation was determined by independent reviewers for selected SENSIMED Triggerfish 30-second recording intervals for which simultaneous or close to simultaneous heart rate data was recorded. Intervals for which the oscillation frequency on SENSIMED Triggerfish pattern matched heart rate +/- 15% (tolerance due to noise caused by eye and lid movements) were considered accurate. The percentage of accurate intervals was calculated and expected to be at least 75%.
Time Frame	in selected 30-second SENSIMED Triggerfish recording intervals during sleep

Outcome Measure Data

Analysis Population Description

One subject was excluded from the analysis due to the absence of a 3-mmHg difference in IOP from wake to sleep. Two subjects were excluded since they had less than 80% of expected SENSIMED Triggerfish data. One subject was excluded from the analysis due to an invalid SENSIMED Triggerfish recording.

Arm/Group Title	SENSIMED Triggerfish
Arm/Group Description
Measure Participants	29
Number (95% Confidence Interval) [% of accurate recording intervals]	86.5

Adverse Events

Arm/Group Title	SENSIMED Triggerfish
Arm/Group Description
All Cause Mortality
	SENSIMED Triggerfish
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	SENSIMED Triggerfish
	Affected / at Risk (%)	# Events
Total	0/33 (0%)
Other (Not Including Serious) Adverse Events
	SENSIMED Triggerfish
	Affected / at Risk (%)	# Events
Total	15/33 (45.5%)
Eye disorders
ocular hyperemia	8/33 (24.2%)	8
punctate keratitis	7/33 (21.2%)	7
eye pressure mark	5/33 (15.2%)	5
vision blurred	1/33 (3%)	1
eyelid edema	1/33 (3%)	1
corneal disorder	1/33 (3%)	1

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.