This study is currently recruiting participants.
Verified August 2012 by University of Michigan
University of Nebraska
Information provided by (Responsible Party):
Sayoko E. Moroi, University of Michigan
First received: August 7, 2012
Last updated: August 29, 2012
Last verified: August 2012
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.
||Observational Model: Cohort
Time Perspective: Prospective
Biospecimen Retention: Samples With DNA
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.
Blood samples are being collected
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||January 2015 (Final data collection date for primary outcome measure)
To compare the variation in response to timolol
To compare the variation in response to latanoprost
|Ages Eligible for Study:
||40 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Control subjects who have healthy eyes
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01677507
|University of Michigan
|Ann Arbor, Michigan, United States, 48105 |
|Contact: Sayoko Moroi, MD, PhD 734-763-3732 email@example.com |
|Contact: Diana Burnett, MS 734-936-2929 firstname.lastname@example.org |
|Principal Investigator: Sayoko Moroi, MD, PhD |
|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 |
|University of Nebraska Medical Center
|Omaha, Nebraska, United States |
|Contact: Carol Toris, PhD 402-559-7492 email@example.com |
|Contact: Donna Neely 402-559-7492 firstname.lastname@example.org |
|Principal Investigator: Carol Toris, PhD |
University of Michigan
University of Nebraska
No publications provided
||Sayoko E. Moroi, PI, University of Michigan
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 7, 2012
||August 29, 2012
||United States: Institutional Review Board
United States: Food and Drug Administration
Keywords provided by University of Michigan:
aqueous humor dynamics
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 21, 2013