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Glaucoma Biomarkers

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ClinicalTrials.gov Identifier: NCT01677507
Recruitment Status : Completed
First Posted : September 3, 2012
Results First Posted : September 13, 2017
Last Update Posted : September 13, 2017
Sponsor:
Collaborators:
University of Nebraska
Mayo Clinic
National Eye Institute (NEI)
Information provided by (Responsible Party):
Sayoko E. Moroi, University of Michigan

Study Description
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Brief Summary:
Glaucoma is a major cause of blindness. The inability to predict a patient's IOP response to medications is a critical barrier for the clinician to consistently provide highly effective IOP-based treatments. Current trial-and error approaches to glaucoma management are inefficient and have not addressed this barrier as there are no predictive factors for drug response. Our long-term goal is to improve outcomes by identifying biomarkers and environmental factors that profile a patient at risk for glaucoma by age-of-onset, rate of disease progression, "poor response" to treatment, and large IOP fluctuation. Our purpose of this research project is to address this critical barrier by focusing on physiological factors that predict IOP response to drugs.

Condition or disease Intervention/treatment Phase
Glaucoma Healthy Drug: Variation in eye pressure response to timolol and latanoprost treatment Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aqueous Humor Dynamic Components That Determine Intraocular Pressure Variance
Study Start Date : August 2012
Actual Primary Completion Date : August 30, 2016
Actual Study Completion Date : August 30, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: timolol
To compare the variation in response to timolol between individuals
 Drug: Variation in eye pressure response to timolol and latanoprost treatment
Arm 1 is to test for variation in eye pressure response to timolol. Arm 2 is to test for variation in eye pressure response to latanoprost.
Active Comparator: latanoprost
To compare the variation in response to latanoprost between individuals
 Drug: Variation in eye pressure response to timolol and latanoprost treatment
Arm 1 is to test for variation in eye pressure response to timolol. Arm 2 is to test for variation in eye pressure response to latanoprost.


Outcome Measures
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Primary Outcome Measures :
  1. Variation in Eye Pressure Between Individuals. [ Time Frame: Measurement after 1 week of drug treatment ]
    Eye pressure is a steady state quantitative trait that is measured in mm Hg. Eye pressure is determined by the following physiological factors (units of measure): eye fluid or aqueous humor production (microliters/minute), aqueous humor outflow (microliters/minute), outflow resistance (microliters/minute/mm Hg) and venous pressure (mm Hg) of the eye. All of these physiological factors will be determined under baseline condition and under glaucoma drug treatment.


Secondary Outcome Measures :
  1. Variation in Aqueous Flow Between Individuals. [ Time Frame: 1 week after treatment ]
    Aqueous flow production (microliters/minute) will be determined under baseline condition and under glaucoma drug treatment.

  2. Variation in Episcleral Venous Pressure. [ Time Frame: 1 week treatment ]
    Episcleral venous pressure (mm Hg) of the eye will be determined under baseline condition and under glaucoma drug treatment.


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Either gender.
  • Any self-declared ethnoracial category.
  • Greater than or equal to 40 years.
  • Healthy eyes with the crystalline lens, without glaucoma (cup:disc ratio < 0.8 both eyes; asymmetry of cup:disc ratio between eyes < 0.2).
  • Open angles.
  • Ability to cooperate for aqueous humor dynamic studies.
  • Nonprescription and prescription topical ophthalmic products and systemic medications other than those mentioned in the exclusion criteria will be allowed during the study.
  • Contact lenses removed prior to topical fluorescein instillation, and not used until the end of each fluorophotometry session.
  • Able to participate on site over the multi-visit study period.

Exclusion Criteria:

  • Women who are pregnant due to IOP changes.
  • Any form of glaucoma, including extremely narrow angle with complete or partial closure.
  • Current use of any glaucoma medication, either topically or orally.
  • Chronic or recurrent inflammatory eye disease.
  • Ocular trauma within the past 6 months.
  • Ocular infection or ocular inflammation in the past 3 months.
  • Clinically significant retinal disease.
  • Any abnormality preventing reliable fluorophotometry of either eye, such as corneal scarring or severe dry eye that results in punctate fluorescein staining of the cornea.
  • Intraocular surgery within 6 months.
  • Serious hypersensitivity to any components of the study medications or risk from treatment with glaucoma medications, such as severe asthma or emphysema.
  • Subjects must be on a stable regimen for at least 30 days prior to the Visit 1 regarding a chronic systemic medication that may affect IOP (i.e., sympathomimetic agents, beta-blockers, alpha-adrenergic agonists, alpha-adrenergic blockers, calcium channel blockers, angiotensin converting enzyme inhibitors, etc.). Any change of such medication during the study period will result in exclusion.
  • Use of any glucocorticoid by any route. Subject must be washed out of the glucocorticoid for at least 2 weeks before study entry.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01677507


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48105
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States
Sponsors and Collaborators
University of Michigan
University of Nebraska
Mayo Clinic
National Eye Institute (NEI)
Investigators
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Principal Investigator: Sayoko E Moroi, MD, PhD University of Michigan
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sayoko E. Moroi, PI, University of Michigan
ClinicalTrials.gov Identifier: NCT01677507    
Other Study ID Numbers: HUM00052276
R01EY022124 ( U.S. NIH Grant/Contract )
First Posted: September 3, 2012    Key Record Dates
Results First Posted: September 13, 2017
Last Update Posted: September 13, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sayoko E. Moroi, University of Michigan:
glaucoma
aqueous humor dynamics
intraocular pressure
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases
Timolol
Latanoprost
Adrenergic beta-Antagonists
Adrenergic Antagonists
 Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents