GlaucomaPhase 4NCT01677507
Glaucoma Biomarkers
A Phase 4 study testing Variation in eye pressure response to timolol and latanoprost treatment in people with Glaucoma and Healthy, run by University of Michigan at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- What is being tested?
- Variation in eye pressure response to timolol and latanoprost treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2012to 30 Aug 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Michigan
Ann Arbor, Michigan, 48105
University of Nebraska Medical Center
Omaha, Nebraska
Mayo Clinic
Rochester, Minnesota
About this study
Official title: 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.
- Being tested
- Variation in eye pressure response to timolol and latanoprost treatment
- Keywords
- glaucoma, aqueous humor dynamics, intraocular pressure
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| timolol | Experimental | To compare the variation in response to timolol between individuals Receives: Drug: Variation in eye pressure response to timolol and latanoprost treatment |
| latanoprost | Active comparator | To compare the variation in response to latanoprost between individuals Receives: Drug: Variation in eye pressure response to timolol and latanoprost treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Measurement after 1 week of drug treatment
Secondary outcomes (2)
Variation in Aqueous Flow Between Individuals.
Aqueous flow production (microliters/minute) will be determined under baseline condition and under glaucoma drug treatment.
Measured: 1 week after 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.
Measured: 1 week treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2012 (estimated)
- Study startAug 2012
- Primary completion30 Aug 2016
- Study completion30 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nebraska, Mayo Clinic, National Eye Institute (NEI)
- Responsible party
- Principal investigator, Sayoko E. Moroi, University of Michigan
- Investigators
- Sayoko E Moroi, MD, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677507
- Sponsor's protocol ID
- HUM00052276
- Other IDs
- R01EY022124
- Status last verified
- Aug 2017
- First submitted
- 7 Aug 2012
- Last updated
- 13 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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. 2026 Jan-Feb;9(1):126-134. doi: 10.1016/j.ogla.2025.07.010. Epub 2025 Aug 11.
PubMed 40803602Kolli 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.
PubMed 34610254Man 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.
PubMed 29226268
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aqueous Humor Dynamic Components That Determine Intraocular Pressure Variance
- ClinicalTrials.gov ID
- NCT01677507
- Acronym / sponsor ID
- HUM00052276
- Keywords
- glaucoma, aqueous humor dynamics, intraocular pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- University of Nebraska, Mayo Clinic, National Eye Institute (NEI)
- Study start
- Aug 2012
- Primary completion
- 30 Aug 2016 (actual)
- Study completion
- 30 Aug 2016 (actual)
- First posted
- 3 Sep 2012 (estimated)
- Results
- Posted 13 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| timolol | Experimental | Drug: Variation in eye pressure response to timolol and latanoprost treatmentTo compare the variation in response to timolol between individuals |
| latanoprost | Active comparator | Drug: Variation in eye pressure response to timolol and latanoprost treatmentTo compare the variation in response to latanoprost between individuals |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Variation in eye pressure response to timolol and latanoprost treatmentArm 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. | Drug | latanoprost, timolol |
Primary outcome
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.
2 secondary outcomes
Variation in Aqueous Flow Between Individuals.
Time frame: 1 week after treatment
Variation in Episcleral Venous Pressure.
Time frame: 1 week treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40803602Liu 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. 2026 Jan-Feb;9(1):126-134. doi: 10.1016/j.ogla.2025.07.010. Epub 2025 Aug 11.
- Derived from this study: PubMed 34610254Kolli 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.
- Derived from this study: PubMed 29226268Man 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sayoko E Moroi, MD, PhD principal investigator
University of Michigan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Variation in eye pressure response to timolol and latanoprost treatment in people with Glaucoma and Healthy, run by University of Michigan at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in Eye Pressure Between Individuals. (time frame: Measurement after 1 week of drug treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01677507, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2017.