Trial Outcomes & Findings for SENSIMED Triggerfish Safety and Tolerability (NCT NCT01319617)
NCT ID: NCT01319617
Last Updated: 2013-09-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
After 24 hours of device wear
Results posted on
2013-09-09
Participant Flow
Recruitment from medical clinic from January to September 2011
Participant milestones
| Measure |
SENSIMED Triggerfish
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 Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SENSIMED Triggerfish Safety and Tolerability
Baseline characteristics by cohort
| Measure |
SENSIMED Triggerfish
n=41 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
|
Age Continuous
|
54.6 years
STANDARD_DEVIATION 16.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After 24 hours of device wearOcular 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.
Outcome measures
| Measure |
SENSIMED Triggerfish
n=40 Participants
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
|
|---|---|
|
Ocular Discomfort
|
25.5 mm
Standard Deviation 18.6
|
Adverse Events
SENSIMED Triggerfish
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SENSIMED Triggerfish
n=41 participants at risk
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
|
|---|---|
|
Eye disorders
conjunctival edema
|
2.4%
1/41 • Number of events 1
|
|
Eye disorders
device intolerance
|
2.4%
1/41 • Number of events 1
|
|
Eye disorders
eye irritation
|
7.3%
3/41 • Number of events 3
|
|
Eye disorders
eye pressure mark
|
31.7%
13/41 • Number of events 17
|
|
Eye disorders
eye pruritus
|
7.3%
3/41 • Number of events 3
|
|
Eye disorders
ocular discomfort
|
2.4%
1/41 • Number of events 2
|
|
Eye disorders
ocular hyperemia
|
78.0%
32/41 • Number of events 56
|
|
Eye disorders
punctate keratitis
|
14.6%
6/41 • Number of events 6
|
|
Eye disorders
vision blurred
|
80.5%
33/41 • Number of events 60
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place