Trial Outcomes & Findings for Effect of Topical Phenylephrine 2.5% on EVP in Normal Human Eyes (NCT NCT02965924)

Last Updated: 2019-10-23

Results Overview

EVP will be measured non-invasively using a custom-modified slit-lamp mounted venomanometer. This device utilizes the pressure chamber technique, in which a clear flexible balloon is placed against the conjunctival surface of the eye, and the pressure is increased until an episcleral vein is noted to blanch. The system for pressure-chamber based venomanometry includes a computer-controlled motor drive to increase pressure automatically, a transducer to record pressure, and a high-definition video camera to record vein collapse. Pressure measurements are synchronized with the video stream and image analysis software is used to determine the pressure required to collapse the vein to a specific pre-determined degree as measured in mmHg.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

baseline, 60 minutes

Results posted on

2019-10-23

Participant Flow

Participant milestones

Participant milestones
Measure	Phenylephrine Subjects will receive topical phenylephrine 2.5% eye drop instilled in one eye after all baseline measurements. Phenylephrine 2.5%: Instilling phenylephrine 2.5% eye drop
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Topical Phenylephrine 2.5% on EVP in Normal Human Eyes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phenylephrine n=20 Participants Subjects will receive topical phenylephrine 2.5% eye drop instilled in one eye after all baseline measurements. Phenylephrine 2.5%: Instilling phenylephrine 2.5% eye drop
Age, Continuous	35.4 years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 60 minutes

Outcome measures

Outcome measures
Measure	Phenylephrine n=20 Participants Subjects will receive topical phenylephrine 2.5% eye drop instilled in one eye after all baseline measurements. Phenylephrine 2.5%: Instilling phenylephrine 2.5% eye drop
Change in Episcleral Venous Pressure (EVP)	7.2 mmHg Standard Deviation 2.0

SECONDARY outcome

Timeframe: baseline, 60 minutes

Intraocular pressure will be measured in mmHg after topical anesthesia by using the pneumatonometer. There will be a minimum of three IOP measurements and a mean will be accepted as IOP.

Outcome measures

Outcome measures
Measure	Phenylephrine n=20 Participants Subjects will receive topical phenylephrine 2.5% eye drop instilled in one eye after all baseline measurements. Phenylephrine 2.5%: Instilling phenylephrine 2.5% eye drop
Change in Intraocular Pressure (IOP)	15.0 mmHg Standard Deviation 2.0

Adverse Events

Phenylephrine

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

Arthur J. Sit, MD

Mayo Clinic

Phone: 507-284-2787

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place