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

NCT ID: NCT02965924

Last Updated: 2019-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-10-01

Brief Summary

Phenylephrine hydrochloride ophthalmic solution is an alpha-1 adrenergic receptor agonist commonly used topically for dilation prior to ocular fundus examination. In the eye, phenylephrine acts locally as a potent vasoconstrictor and mydriatic by constricting ophthalmic blood vessels and the radial dilator muscle of the iris. Episcleral venous pressure (EVP) is a determinant of intraocular pressure (IOP) and can be measured non-invasively by venomanometry. Since phenylephrine is a vasoconstrictor, it may affect episcleral venous tone, but the effect on EVP is unknown. Understanding the physiology of episcleral veins helps us in better understanding of pathophysiology of glaucoma.

Conditions

Assess Phenylephrine on EVP and IOP

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Phenylephrine

Subjects will receive topical phenylephrine 2.5% eye drop instilled in one eye after all baseline measurements.

Group Type: EXPERIMENTAL

Phenylephrine 2.5%

Intervention Type: DRUG

Instilling phenylephrine 2.5% eye drop

Interventions

Phenylephrine 2.5%

Instilling phenylephrine 2.5% eye drop

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Any self-declared ethno-racial category.
• Medically healthy subjects.
• Subjects with two healthy eyes.
• Intraocular pressure (IOP) less than 22 mmHg in each eye.
• Best-corrected visual acuity (BCVA) in each eye 20/50 or better.
• Open angles in both eyes.
• Contact lens wear stopped at least 3 days prior to study, and during the study.
• Ability to cooperate for examinations required for study.

Exclusion Criteria

• Chronic or acute ophthalmic diseases including glaucoma, wet type macular degeneration, uveitis and clinically significant cataract.
• Evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis.
• Cornea pathologic changes preventing reliable measurement.
• Narrow anterior chamber angle.
• Previous intraocular surgeries, laser procedures, and intravitreal injections.
• Previous corneal refractive surgeries.
• Myopia greater than -6.00 D spherical equivalent.
• Hyperopia greater than +2.00 D spherical equivalent.
• Lack of suitable episcleral vein for measurement.
• Ocular trauma within the past 6 months.
• Ocular infection or ocular inflammation in the past 3 months.
• Ocular medication of any kind within 30 days of study visit.
• Known hypersensitivity to Phenylephrine or topical anesthetic medication.
• Severe hypertension: Systolic blood pressure greater than 180 mmHg and/or diastolic blood pressure greater than 105 mmHg.
• A known history of ischemic heart disease (angina or myocardial infarction), cerebrovascular accidents, cardiac arrhythmias, cerebral or aortic aneurysms.
• Uncontrolled diabetes mellitus.
• Uncontrolled hyperthyroidism.
• Use of some systemic medications within 30 days prior to study including: β-adrenergic antagonists, α-adrenergic agonists and antagonists, calcium channel blockers, diuretics, vasodilators, monoamine oxidase inhibitors, and systemic steroids.
• Participation in any interventional study within the past 30 days prior to study visit.
• Women who are pregnant.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Arthur J. Sit, M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arthur J Sit, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

16-007077

Identifier Type: -

Identifier Source: org_study_id