Circadian Rhythms of Aqueous Humor Dynamics in Humans

NCT00572936 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 0405-05-FB
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to identify physiological, pharmacological and pathological circadian fluctuations in aqueous humor inflow and outflow, systemic blood pressure and ocular blood flow in humans.

Conditions

Glaucoma

Keywords

Glaucoma; Ocular Hypertension; Timolol®, Latanoprost® and Dorzolamide®

Outcome Measures

Primary Outcomes (8)

• Intraocular Pressure

  Intra-ocular Pressure was measured by applanation tonometry

  2 weeks

• Aqueous Flow

  aqueous flow measurements was calculated using fluorophotometry measurements.

  2 weeks

• Central Corneal Thickness

  central corneal thickness was measured by ultrasound pachymetry

  2 weeks

• Anterior Chamber Volume

  Anterior chamber volume was measured by A-scan ultrasound biometry, daytime

  2 weeks

• Blood Pressure

  blood pressure was measured by sphygmomanometry

  2 weeks

• Episcleral Venous Pressure

  Episcleral venous pressure was measured by venomenometry

  2 weeks

• Outflow Facility

  outflow facility was calculated using fluorophotometry and tonography

  2 weeks

• Uvescleral Outflow

  uvescleral outflow was calulated using goldmann equation

  2 weeks

Study Arms (1)

Latanoprost/Dorzolamide/Timolol

OTHER

The participants received latanoprost at night and vehicle in the morning for two weeks, then 6 week washout, then Dorzolamide BID for two weeks, then 6 week washout, then Timolol BID for two weeks. The order in which the participants received the three different drugs was random.

Drug: Latanoprost; Drug: Dorzolamide; Drug: Timolol

Interventions

Latanoprost DRUG

prostaglandin

Also known as: xalatan

Latanoprost/Dorzolamide/Timolol

Dorzolamide DRUG

carbonic anhydrase inhibitor

Also known as: trusopt

Latanoprost/Dorzolamide/Timolol

Timolol DRUG

beta blocker

Also known as: Timoptic, Betimol, Timoptic-xe, Istalol, Timoptic Ocudose

Latanoprost/Dorzolamide/Timolol

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be nineteen (19) years of age or older. Subjects must be able and willing to give written informed consent \[i.e., each subject will be given ample time to read (or have read to them) the consent form, ask any questions they may have regarding the study, and have a clear understanding of the study as well as the procedures involved, prior to signing the consent form\].
• Subjects must exhibit a willingness to comply with the protocol and investigator's instructions.
• Subjects must have been previously diagnosed with unilateral or bilateral ocular hypertension at least six months prior to the screening visit.
• Subjects must exhibit baseline IOPs between 21 and 35 mmHg (inclusive); the average IOP between eyes must be ≤ 5 mmHg
• Subjects will be age matched to ocular hypotensive subjects
• Subjects must exhibit baseline IOPs between 12 and 20 mmHg (inclusive); the average IOP between eyes must be ≤ 5 mmHg

You may not qualify if:

• Age less than nineteen years old.
• Women who are pregnant, lactating or of childbearing potential who are not using highly effective 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 three (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 (including latanoprost, unoprostone, travoprost and bimatoprost) 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 preclude 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 topical or systemic beta blockers, prostaglandins, or sulfa drugs.
• History of severe, unstable or uncontrolled cardiovascular, hepatic or renal disease.

Sponsors & Collaborators

• University of Nebraska: lead
• Pfizer: collaborator

Study Sites (1)

University of Nebraska Medical Center, Department of Ophthalmolgy and Visual Sciences

Omaha, Nebraska, 68198-5540, United States

Location

Related Publications (1)

• Gulati V, Fan S, Zhao M, Maslonka MA, Gangahar C, Toris CB. Diurnal and nocturnal variations in aqueous humor dynamics of patients with ocular hypertension undergoing medical therapy. Arch Ophthalmol. 2012 Jun;130(6):677-84. doi: 10.1001/archophthalmol.2011.2573.

  PMID: 22332206 RESULT

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

Interventions

Latanoprost; dorzolamide; Timolol

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines

Results Point of Contact

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

ctoris@unmc.edu

402-559-1852

Study Officials

• Carl B Camras, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2007
• First Posted: December 13, 2007
• Study Start: March 13, 2006
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: October 24, 2023
• Results First Posted: February 14, 2018

Record last verified: 2023-10

Locations

US (1)