Trial Outcomes & Findings for Efficacy of 24-hour Intraocular Pressure Fluctuation Recording With the SENSIMED Triggerfish Contact Lens Sensor (NCT NCT01390779)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

33 participants

Primary outcome timeframe

from 1 hour before sleep to 1 hour after sleep

Results posted on

2014-01-20

Participant Flow

Recruitment from July 2011 to May 2012, from medical clinic and investigator's patient database.

Regular sleep cycle in the week preceding the study.

Participant milestones

Participant milestones
Measure	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. 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.
Overall Study STARTED	33
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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. 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.
Overall Study Physician Decision	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SENSIMED Triggerfish n=33 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	35 years STANDARD_DEVIATION 14.4 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants

PRIMARY outcome

Timeframe: from 1 hour before sleep to 1 hour after sleep

Population: 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.

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.

Outcome measures

Outcome measures
Measure	SENSIMED Triggerfish n=29 Participants
SENSIMED Triggerfish Efficacy	56.9 mV/h Standard Deviation 40.5

PRIMARY outcome

Timeframe: in selected 30-second SENSIMED Triggerfish recording intervals during sleep

Population: 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.

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%.

Outcome measures

Outcome measures
Measure	SENSIMED Triggerfish n=29 Participants
SENSIMED Triggerfish Efficacy	86.5 % of accurate recording intervals Interval 75.0 to 93.2

Adverse Events

SENSIMED Triggerfish

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	SENSIMED Triggerfish n=33 participants at risk
Eye disorders ocular hyperemia	24.2% 8/33 • Number of events 8
Eye disorders punctate keratitis	21.2% 7/33 • Number of events 7
Eye disorders eye pressure mark	15.2% 5/33 • Number of events 5
Eye disorders vision blurred	3.0% 1/33 • Number of events 1
Eye disorders eyelid edema	3.0% 1/33 • Number of events 1
Eye disorders corneal disorder	3.0% 1/33 • Number of events 1

Additional Information

Mona Moshtaghi

UCSD

Phone: 858 534-6290

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place