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OpenTrials
Completed

NCT Number: NCT01677507

Glaucoma Biomarkers

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Michigan, Ann Arbor, Michigan, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Variation in eye pressure response to timolol and latanoprost treatment

Drug

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Mayo Clinic
  • National Eye Institute (NEI)
  • University of Nebraska

Registry information

Official study title

Aqueous Humor Dynamic Components That Determine Intraocular Pressure Variance

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Sep 3, 2012
Registry last updated
Sep 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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