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Glaucoma Biomarkers

Primary Purpose

Glaucoma, Healthy

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Variation in eye pressure response to timolol and latanoprost treatment
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring glaucoma, aqueous humor dynamics, intraocular pressure

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Michigan
  • Mayo Clinic
  • University of Nebraska Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

timolol

latanoprost

Arm Description

To compare the variation in response to timolol between individuals

To compare the variation in response to latanoprost between individuals

Outcomes

Primary Outcome Measures

Variation in Eye Pressure Between Individuals.
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 Outcome Measures

Variation in Aqueous Flow Between Individuals.
Aqueous flow production (microliters/minute) will be determined under baseline condition and under glaucoma drug treatment.
Variation in Episcleral Venous Pressure.
Episcleral venous pressure (mm Hg) of the eye will be determined under baseline condition and under glaucoma drug treatment.

Full Information

First Posted
August 7, 2012
Last Updated
August 14, 2017
Sponsor
University of Michigan
Collaborators
University of Nebraska, Mayo Clinic, National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT01677507
Brief Title
Glaucoma Biomarkers
Official Title
Aqueous Humor Dynamic Components That Determine Intraocular Pressure Variance
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 30, 2016 (Actual)
Study Completion Date
August 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
University of Nebraska, Mayo Clinic, National Eye Institute (NEI)

4. Oversight

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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Healthy
Keywords
glaucoma, aqueous humor dynamics, intraocular pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
timolol
Arm Type
Experimental
Arm Description
To compare the variation in response to timolol between individuals
Arm Title
latanoprost
Arm Type
Active Comparator
Arm Description
To compare the variation in response to latanoprost between individuals
Intervention Type
Drug
Intervention Name(s)
Variation in eye pressure response to timolol and latanoprost treatment
Intervention Description
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 Outcome Measure Information:
Title
Variation in Eye Pressure Between Individuals.
Description
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.
Time Frame
Measurement after 1 week of drug treatment
Secondary Outcome Measure Information:
Title
Variation in Aqueous Flow Between Individuals.
Description
Aqueous flow production (microliters/minute) will be determined under baseline condition and under glaucoma drug treatment.
Time Frame
1 week after treatment
Title
Variation in Episcleral Venous Pressure.
Description
Episcleral venous pressure (mm Hg) of the eye will be determined under baseline condition and under glaucoma drug treatment.
Time Frame
1 week treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sayoko E Moroi, MD, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34610254
Citation
Kolli A, Toris CB, Reed DM, Gilbert J, Sit AJ, Gulati V, Kazemi A, Fan S, Musch DC, Moroi SE. The Effects of Topical Timolol and Latanoprost on Calculated Ocular Perfusion Pressure in Nonglaucomatous Volunteers. J Ocul Pharmacol Ther. 2021 Dec;37(10):565-574. doi: 10.1089/jop.2021.0068. Epub 2021 Oct 4.
Results Reference
derived
PubMed Identifier
29226268
Citation
Man X, Costa R, Ayres BM, Moroi SE. Acetazolamide-Induced Bilateral Ciliochoroidal Effusion Syndrome in Plateau Iris Configuration. Am J Ophthalmol Case Rep. 2016 Oct;3:14-17. doi: 10.1016/j.ajoc.2016.05.003. Epub 2016 May 17.
Results Reference
derived

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Glaucoma Biomarkers

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