Glaucoma Biomarkers

This study is currently recruiting participants.
Verified June 2013 by University of Michigan
Sponsor:
Collaborators:
University of Nebraska
Mayo Clinic
Information provided by (Responsible Party):
Sayoko E. Moroi, University of Michigan
ClinicalTrials.gov Identifier:
NCT01677507
First received: August 7, 2012
Last updated: June 25, 2013
Last verified: June 2013
  Purpose

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 Intervention
Glaucoma
Healthy
Drug: Variation in eye pressure response to timolol and latanoprost treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Aqueous Humor Dynamic Components That Determine Intraocular Pressure Variance

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Variation in eye pressure between individuals. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 150
Study Start Date: August 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01677507

Contacts
Contact: Sayoko E Moroi, MD, PhD 734-763-3732 smoroi@med.umich.edu
Contact: Diana Burnett, MS 734-936-2929 burnettd@med.umich.edu

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Sayoko Moroi, MD, PhD    734-763-3732    smoroi@med.umich.edu   
Contact: Diana Burnett, MS    734-936-2929    burnettd@med.umich.edu   
Principal Investigator: Sayoko Moroi, MD, PhD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States
Contact: Arthur Sit, MD    507-284-2787    Sit.Arthur@mayo.edu   
Contact: Nitika Arora, MBBS    507-284-2787    Arora.Nitika@mayo.edu   
Principal Investigator: Arthur Sit, MD         
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States
Contact: Carol Toris, PhD    402-559-7492    ctoris@unmc.edu   
Contact: Donna Neely    402-559-7492    dneely@unmc.edu   
Principal Investigator: Carol Toris, PhD         
Sponsors and Collaborators
University of Michigan
University of Nebraska
Mayo Clinic
  More Information

No publications provided

Responsible Party: Sayoko E. Moroi, PI, University of Michigan
ClinicalTrials.gov Identifier: NCT01677507     History of Changes
Other Study ID Numbers: HUM00052276, R01EY022124
Study First Received: August 7, 2012
Last Updated: June 25, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of Michigan:
glaucoma
aqueous humor dynamics
intraocular pressure

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Timolol
Latanoprost
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents

ClinicalTrials.gov processed this record on April 15, 2014