Trial Outcomes & Findings for Pilot Study on Ambulatory Intraocular Pressure and Blood Pressure Monitoring in Glaucoma (NCT NCT01912599)

NCT ID: NCT01912599

Last Updated: 2016-06-17

Results Overview

The blood pressure value shown in the table is the mean of all measurements taken over the 24 hour period, so it is the average value.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 36 participants
• Primary outcome timeframe: 24 Hours
• Results posted on: 2016-06-17

Participant Flow

Participant milestones

Measure	Non-Glaucomatous Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends. Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period.	Glaucoma Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends. Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period.
Overall Study STARTED	20	16
Overall Study COMPLETED	20	15
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Non-Glaucomatous Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends. Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period.	Glaucoma Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends. Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period.
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Pilot Study on Ambulatory Intraocular Pressure and Blood Pressure Monitoring in Glaucoma

Baseline characteristics by cohort

Measure	Non-Glaucomatous n=20 Participants Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends. Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period.	Glaucoma n=16 Participants Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends. Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period.	Total n=36 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants	8 Participants n=7 Participants	26 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants
Age, Continuous	50.2 years STANDARD_DEVIATION 13.3 • n=5 Participants	66.9 years STANDARD_DEVIATION 11.1 • n=7 Participants	57.3 years STANDARD_DEVIATION 14.8 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	7 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	16 participants n=7 Participants	36 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 Hours

Population: Data for two glaucoma patients were excluded for analysis because * In one patient the IOP recorder malfunctioned just two hours after set up, so data were not available for the entire 24 hours * In the other patient, the wireless sensor was disconnected from the recorder in the middle if the night so data could not be recorded.

The blood pressure value shown in the table is the mean of all measurements taken over the 24 hour period, so it is the average value.

Outcome measures

Measure	Non-Glaucomatous n=20 Participants Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends. Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period.	Glaucoma n=13 Participants Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends. Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period.
Arterial Pressure	100.9 mmHg Standard Deviation 23.6	95.5 mmHg Standard Deviation 11.4

PRIMARY outcome

Timeframe: 24 Hours

The IOP provided is the average of all 144 measurements taken during the 24 hour period.

Outcome measures

Measure	Non-Glaucomatous n=20 Participants Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends. Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period.	Glaucoma n=15 Participants Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends. Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period.
Intraocular Pressure	17.6 mEqv. Standard Deviation 126.5	179.2 mEqv. Standard Deviation 87.2

PRIMARY outcome

Timeframe: 24 Hours

The value shown in the table is the mean of all measurements taken over the 24 hour period, so it is the average value.

Outcome measures

Measure	Non-Glaucomatous n=20 Participants Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends. Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period.	Glaucoma n=15 Participants Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends. Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period.
Mean Perfusion Pressure	90.8 mmHg Standard Deviation 135.6	62.4 mmHg Standard Deviation 12.7

PRIMARY outcome

Timeframe: 24 Hours

The value shown in the table is the mean of all measurements taken over the 24 hour period, so it is the average value.

Outcome measures

Measure	Non-Glaucomatous n=20 Participants Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends. Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period.	Glaucoma n=15 Participants Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends. Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period.
Diastolic Pressure	85.7 mmHg Standard Deviation 9.3	74.6 mmHg Standard Deviation 11.6

PRIMARY outcome

Timeframe: 24 Hours

The value shown in the table is the mean of all measurements taken over the 24 hour period, so it is the average value.

Outcome measures

Measure	Non-Glaucomatous n=20 Participants Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends. Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period.	Glaucoma n=15 Participants Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends. Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period.
Systolic Pressure	146.4 mmHg Standard Deviation 15.2	129.0 mmHg Standard Deviation 35.2

Adverse Events

Non-Glaucomatous

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Glaucoma

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Non-Glaucomatous n=20 participants at risk Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends. Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period.	Glaucoma n=16 participants at risk Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends. Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period.
Eye disorders Corneal Changes	30.0% 6/20 • Number of events 6	18.8% 3/16 • Number of events 3
Eye disorders Conjunctival Changes	5.0% 1/20 • Number of events 1	18.8% 3/16 • Number of events 3
Skin and subcutaneous tissue disorders Cuff Abrasion	0.00% 0/20	6.2% 1/16 • Number of events 1

Additional Information

Jean-Claude Mwanza, MD, MPH, PhD

University of North Carolina

Phone: 919-843-4917

Email: jean-claude_mwanza@med.unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place