Trial Outcomes & Findings for IOP Fluctuations in Patients With Sleep Apnea With or Without Primary Open Angle Glaucoma Using Positive Airway Pressure (NCT NCT01560975)

Results Overview

24-hour IOP fluctuation pattern recorded using Triggerfish in patients with moderate to severe OSAS. * using CPAP in patients with or without POAG * not using CPAP in patients with or without POAG

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

24 hours

Results posted on

2016-01-27

Participant Flow

Participant milestones

Participant milestones
Measure	Sensimed Triggerfish SENSIMED Triggerfish®: Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

IOP Fluctuations in Patients With Sleep Apnea With or Without Primary Open Angle Glaucoma Using Positive Airway Pressure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sensimed Triggerfish n=10 Participants SENSIMED Triggerfish®: Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours
Age, Continuous	65.2 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

24-hour IOP fluctuation pattern recorded using Triggerfish in patients with moderate to severe OSAS. * using CPAP in patients with or without POAG * not using CPAP in patients with or without POAG

Outcome measures

Outcome measures
Measure	POAG/CPAP n=4 Participants POAG patients with CPAP therapy	noPOAG/CPAP n=4 Participants Subjects with CPAP	POAG/no CPAP POAG patients without CPAP therapy	noPOAG/ no CPAP No POAG patients without CPAP therapy
Relationship Between IOP Fluctuation Pattern With or Without CPAP Therapy in Patients With Moderate to Severe OSAS With or Without POAG	44.4 mVEq/h Standard Deviation 34.8	42.2 mVEq/h Standard Deviation 40.7	—	—

SECONDARY outcome

Timeframe: 24-hours

Heart rate and ocular pulsation rate during sleep: * using CPAP in patients with or without POAG * not using CPAP in patients with or without POAG

Outcome measures

Outcome measures
Measure	POAG/CPAP n=4 Participants POAG patients with CPAP therapy	noPOAG/CPAP n=4 Participants Subjects with CPAP	POAG/no CPAP n=4 Participants POAG patients without CPAP therapy	noPOAG/ no CPAP n=4 Participants No POAG patients without CPAP therapy
Relationship Between the 24-hour IOP Fluctuation Patterns and Physiologic Parameters	0.36 Correlation Standard Deviation 0.4	0.92 Correlation Standard Deviation 0.03	0.47 Correlation Standard Deviation 0.33	0.42 Correlation Standard Deviation 0.20

SECONDARY outcome

Timeframe: 30 min

IOP pattern immediately after CPAP removal upon waking in patients with or without POAG

Outcome measures

Outcome measures
Measure	POAG/CPAP n=4 Participants POAG patients with CPAP therapy	noPOAG/CPAP n=4 Participants Subjects with CPAP	POAG/no CPAP n=4 Participants POAG patients without CPAP therapy	noPOAG/ no CPAP n=4 Participants No POAG patients without CPAP therapy
Effect After CPAP Removal on the IOP Pattern	-2.6 mvEq Standard Deviation 54	-25.4 mvEq Standard Deviation 69.1	-40.4 mvEq Standard Deviation 89.2	-50.3 mvEq Standard Deviation 91.2

Adverse Events

Sensimed Triggerfish

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Robert Ritch

NYEE

Phone: +1 212 477 7540

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place