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

August 7, 2012
June 25, 2013
August 2012
January 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01677507 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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.
 
Recruiting
150
December 2015
January 2015   (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.
Both
40 Years and older
Yes
Contact: Sayoko E Moroi, MD, PhD 734-763-3732 smoroi@med.umich.edu
Contact: Diana Burnett, MS 734-936-2929 burnettd@med.umich.edu
United States
 
NCT01677507
HUM00052276, R01EY022124
Not Provided
Sayoko E. Moroi, University of Michigan
University of Michigan
  • University of Nebraska
  • Mayo Clinic
  • National Eye Institute (NEI)
Not Provided
University of Michigan
June 2013

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