NCT01677507

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2012

Longer than P75 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2012

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 3, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2016

Completed
1 year until next milestone

Results Posted

Study results publicly available

September 13, 2017

Completed
Last Updated

September 13, 2017

Status Verified

August 1, 2017

Enrollment Period

4.1 years

First QC Date

August 7, 2012

Results QC Date

August 14, 2017

Last Update Submit

August 14, 2017

Conditions

GlaucomaHealthy

Keywords

glaucomaaqueous humor dynamicsintraocular pressure

Outcome Measures

Primary Outcomes (1)

  • 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.

    Measurement after 1 week of drug treatment

Secondary Outcomes (2)

  • Variation in Aqueous Flow Between Individuals.

    1 week after treatment

  • Variation in Episcleral Venous Pressure.

    1 week treatment

Study Arms (2)

timolol

EXPERIMENTAL

To compare the variation in response to timolol between individuals

Drug: Variation in eye pressure response to timolol and latanoprost treatment

latanoprost

ACTIVE COMPARATOR

To compare the variation in response to latanoprost between individuals

Drug: Variation in eye pressure response to timolol and latanoprost treatment

Interventions

Variation in eye pressure response to timolol and latanoprost treatmentDRUG

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.

latanoprosttimolol

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Use of any glucocorticoid by any route. Subject must be washed out of the glucocorticoid for at least 2 weeks before study entry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Michigan

Ann Arbor, Michigan, 48105, United States

Location

Mayo Clinic

Rochester, Minnesota, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, United States

Location

Related Publications (3)

  • Liu M, Reed DM, Fan S, Kazemi A, Gulati V, Sit AJ, Moroi SE, Toris CB. Assessing Agreement of Intraocular Pressure from Four Mechanistically Different Tonometers in the Eye Dynamics and Engineering Network Clinical Trial. Ophthalmol Glaucoma. 2025 Aug 11:S2589-4196(25)00157-7. doi: 10.1016/j.ogla.2025.07.010. Online ahead of print.

    PMID: 40803602DERIVED

  • 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.

    PMID: 34610254DERIVED

  • 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.

    PMID: 29226268DERIVED

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Results Point of Contact

Title
Dr. Sayoko Moroi
Organization
University of Michigan
smoroi@med.umich.edu
734-763-3732

Study Officials

  • Sayoko E Moroi, MD, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

August 7, 2012

First Posted

September 3, 2012

Study Start

August 1, 2012

Primary Completion

August 30, 2016

Study Completion

August 30, 2016

Last Updated

September 13, 2017

Results First Posted

September 13, 2017

Record last verified: 2017-08

Locations

US(3)