Trial Outcomes & Findings for Twenty-four Hour Intraocular Pressure Patterns in Patients With Uncontrolled Thyroid Eye Disease (NCT NCT01798966)

Results Overview

To investigate the difference in SENSIMED Triggerfish output during transition from wake to sleep states before and after orbital decompression

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

24 hours

Results posted on

2016-03-11

Participant Flow

Participant milestones

Participant milestones
Measure	SENSIMED Triggerfish All patients included in the device group
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Twenty-four Hour Intraocular Pressure Patterns in Patients With Uncontrolled Thyroid Eye Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SENSIMED Triggerfish n=10 Participants All patients included in the device group
Age, Continuous	61.8 years STANDARD_DEVIATION 21.6 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants
Tolerability of CLS	1.5 units on a scale STANDARD_DEVIATION 0.7 • n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

To investigate the difference in SENSIMED Triggerfish output during transition from wake to sleep states before and after orbital decompression

Outcome measures

Outcome measures
Measure	SENSIMED Triggerfish n=10 Participants SENSIMED Triggerfish worn for 24h
Change in IOP Before and After Orbital Decompression Surgery	18 mVEq (Sensismed Triggerfish output unit) Standard Deviation 43.8

SECONDARY outcome

Timeframe: 24 hours

The pattern of IOP in patients with TED will be compared with the pattern of IOP readings in normal subjects as well as glaucomatous patients

Outcome measures

Outcome measures
Measure	SENSIMED Triggerfish n=10 Participants SENSIMED Triggerfish worn for 24h
IOP Patterns	102.2 mvEq Standard Deviation 52.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 days

Safety will be evaluated throughout the duration of the study by collecting all adverse events

Outcome measures

Outcome measures
Measure	SENSIMED Triggerfish n=10 Participants SENSIMED Triggerfish worn for 24h
Adverse Events and Serious Adverse Events	3 Number of AE

Adverse Events

SENSIMED Triggerfish

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	SENSIMED Triggerfish n=10 participants at risk All patients included in the device group
Eye disorders Mild blurred vision	50.0% 5/10 • From inform consent signature to 30 days after last exposure to device
Eye disorders Mild hyperemia and palpebral conjunctiva	100.0% 10/10 • From inform consent signature to 30 days after last exposure to device
Eye disorders Superficial Punctate keratitis	20.0% 2/10 • From inform consent signature to 30 days after last exposure to device

Additional Information

Anjali Parekh

Hamilton Glaucoma center

Phone: +1858 822-1553

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place