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Glaucoma Biomarkers

This study has been completed.
Sponsor:
Collaborators:
University of Nebraska
Mayo Clinic
National Eye Institute (NEI)
Information provided by (Responsible Party):
Sayoko E. Moroi, University of Michigan
ClinicalTrials.gov Identifier:
NCT01677507
First received: August 7, 2012
Last updated: May 2, 2017
Last verified: May 2017
August 7, 2012
May 2, 2017
August 2012
August 30, 2016   (Final data collection date for primary outcome measure)
Variation in eye pressure between individuals. [ Time Frame: 12 weeks ]
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.
Same as current
Complete list of historical versions of study NCT01677507 on ClinicalTrials.gov Archive Site
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Glaucoma Biomarkers
Aqueous Humor Dynamic Components That Determine Intraocular Pressure Variance
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Glaucoma
  • Healthy
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.
  • Experimental: timolol
    To compare the variation in response to timolol between individuals
    Intervention: Drug: Variation in eye pressure response to timolol and latanoprost treatment
  • Active Comparator: latanoprost
    To compare the variation in response to latanoprost between individuals
    Intervention: Drug: Variation in eye pressure response to timolol and latanoprost treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
136
August 30, 2016
August 30, 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
40 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01677507
HUM00052276
R01EY022124 ( U.S. NIH Grant/Contract )
Not Provided
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
Not Provided
Sayoko E. Moroi, University of Michigan
University of Michigan
  • University of Nebraska
  • Mayo Clinic
  • National Eye Institute (NEI)
Principal Investigator: Sayoko E Moroi, MD, PhD University of Michigan
University of Michigan
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP