Aqueous Humor Dynamics and Brimonidine

NCT01144494 | Completed Early Phase 1 Results FDA Drug

• 1 other identifier: 0220-10-FB
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center, investigator-masked, crossover study is designed to investigate the circadian rhythms of aqueous humor dynamics in human subjects with ocular hypertension (OHT) before and after intervention with a commonly used ocular hypotensive medication, brimonidine for six weeks.

Conditions

Intraocular Pressure

Keywords

Aqueous Humor Dynamics; Aqueous Humor Dynamics and Circadian Rhythms

Outcome Measures

Primary Outcomes (2)

• Seated Day-time IOP 9 am and 11 am, Supine Day-time IOP 9 am and 11 am, and Seated Night-time IOP 9 pm and 11 pm

  Seated day-time and supine day-time IOP was measured by pneumatonometer at 9 am and 11 am. Seated night-time IOP was measured at 9 pm and 11 pm.

  6 weeks

• Supine Night-time & Day-time Seated Episcleral Venous Pressure (EVP)

  The episcleral venous pressure was measured using the episcleral venomanometer

  6 weeks plus 2 days

Secondary Outcomes (3)

• Aqueous Flow

  6 weeks

• Uveoscleral Outflow

  6 weeks

• Outflow Facility

  6 weeks

Study Arms (2)

Intraocular pressure lowering drug

ACTIVE COMPARATOR

Eyedrops for lowering intraocular pressure

Drug: Brimonidine

Artificial Tears

PLACEBO COMPARATOR

Lubricated eye drops

Drug: Artificial tears

Interventions

Brimonidine DRUG

One drop of brimonidine in each eye three times a day for six weeks.

Also known as: Mirvaso, Alphagan P

Intraocular pressure lowering drug

Artificial tears DRUG

Lubricating drops added three times a day for six weeks

Also known as: Systane

Artificial Tears

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be 19 years of age or older
• Subjects must exhibit a history of untreated IOPs between 21 and 35 mmHg (inclusive)

You may not qualify if:

• Age less than nineteen years old
• Women who are pregnant, lactating or of childbearing potential who are not using birth control measures.
• Aphakia or pseudophakia
• Best corrected visual acuity worse than 20/60 in either eye
• Chronic or recurrent severe ocular inflammatory disease
• Ocular infection or inflammation within (3) months of screening visit.
• History of clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy or retinal detachment.
• Any abnormality preventing reliable tonometry of either eye.
• Previous exposure to: beta-adrenergic antagonists, topical prostaglandin analogues within six (6) weeks of the baseline visit; α-adrenergic agonists within two (2) weeks of the baseline visit; and cholinergic agonists and carbonic anhydrase inhibitors within five (5) days of the treatment initiation visit.
• History of any severe ocular pathology (including severe dry eye) that would prelude the administration of a topical beta blocker, carbonic anhydrase inhibitor, or a topical prostaglandin.
• Any eye with a cup-to-disc ratio greater than 0.8.
• History of intraocular surgery
• History of ocular laser surgery
• History of severe or serious hypersensitivity to brimonidine or its vehicle.
• History of severe, unstable, or uncontrolled cardiovascular, hepatic or renal disease.

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198-5540, United States

Location

Related Publications (1)

• Fan S, Agrawal A, Gulati V, Neely DG, Toris CB. Daytime and nighttime effects of brimonidine on IOP and aqueous humor dynamics in participants with ocular hypertension. J Glaucoma. 2014 Jun-Jul;23(5):276-81. doi: 10.1097/IJG.0000000000000051.

  PMID: 24886701 RESULT

MeSH Terms

Interventions

Brimonidine Tartrate; Lubricant Eye Drops

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Results Point of Contact

• Title: Carol Toris
• Organization: University of Nebraska Medical Center

ctoris@unmc.edu

402-559-1852

Study Officials

• Carol B Toris, PhD

  Research Instructor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2010
• First Posted: June 15, 2010
• Study Start: August 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 28, 2023
• Results First Posted: April 24, 2019

Record last verified: 2023-11

Locations

US (1)