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| ID | Type | Description | Link |
|---|---|---|---|
| R01EY022124 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Nebraska | OTHER |
| Mayo Clinic | OTHER |
| National Eye Institute (NEI) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| timolol | Experimental | To compare the variation in response to timolol between individuals |
|
| latanoprost | Active Comparator | To compare the variation in response to latanoprost between individuals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Variation in Aqueous Flow Between Individuals. | Aqueous flow production (microliters/minute) will be determined under baseline condition and under glaucoma drug treatment. | 1 week after treatment |
| Variation in Episcleral Venous Pressure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sayoko E Moroi, MD, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48105 | United States | ||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40803602 | Derived | 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. | |
| 34610254 | Derived | 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. |
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135 consented. Prior to baseline measures: 4 were excluded for ineligibility; 6 withdrew consent fully prior to baseline measurements.
After baseline measures: an additional 2 were excluded based on physician decision, and 2 withdrew for participant decision.
Thus, 121 participants are included for period 1.
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| ID | Title | Description |
|---|---|---|
| FG000 | Timolol Followed by Latanoprost | To compare the variation in response to timolol between individuals Variation in eye pressure response to timolol and latanoprost treatment: Arm 1 initial period is to test for variation in eye pressure response to timolol 0.5%, then washout. Period 2 is to test for variation in eye pressure response to latanoprost 0.005%. |
| FG001 | Latanoprost Followed by Timolol | To compare the variation in response to latanoprost between individuals Variation in eye pressure response to timolol and latanoprost treatment: Arm 1 initial period is to test for variation in eye pressure response to latanoprost 0.005%, then washout. Period 2 is to test for variation in eye pressure response to timolol 0.5%. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Initial Assignment |
|
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| Second Assigment |
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In addition to the 119 participants who were randomized to actual treatment, the baseline population includes the 9 who came for full baseline measurements before they were excluded or chose to withdraw.
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| ID | Title | Description |
|---|---|---|
| BG000 | Baseline of Entire Population | Both arms are included because the study design was a cross over intent to treat with glaucoma medications. All participants were treated with both medications. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | mmHg | Measurement after 1 week of drug treatment |
|
16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Timolol | All participants while on timolol and during a post-timolol washout | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sayoko Moroi | University of Michigan | 734-763-3732 | smoroi@med.umich.edu |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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Episcleral venous pressure (mm Hg) of the eye will be determined under baseline condition and under glaucoma drug treatment.
| 1 week treatment |
| Rochester |
| Minnesota |
| United States |
| University of Nebraska Medical Center | Omaha | Nebraska | United States |
| 29226268 | Derived | 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. |
| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Intraocular pressure | Mean | Standard Deviation | mmHg |
|
| Aqueous humor flow | There was missing aqueous flow data on 2 participants. | Mean | Standard Deviation | microliters/min |
|
| Episcleral venous pressure | One site used a different method to measure episcleral venous pressure (n=29) | Mean | Standard Deviation | mmHg |
|
To characterize the response to latanoprost in all participants.
|
|
|
| Secondary | Variation in Aqueous Flow Between Individuals. | Aqueous flow production (microliters/minute) will be determined under baseline condition and under glaucoma drug treatment. | These measurements can be difficult for participants to tolerate, so sometimes values are missing. | Posted | Mean | Standard Deviation | microliters/min | 1 week after treatment |
|
|
|
|
| Secondary | Variation in Episcleral Venous Pressure. | Episcleral venous pressure (mm Hg) of the eye will be determined under baseline condition and under glaucoma drug treatment. | These measures can be difficult to obtain, so sometimes participants do not tolerate it and some values are missing. | Posted | Mean | Standard Deviation | mmHg | 1 week treatment |
|
|
|
|
| 119 |
| 0 |
| 119 |
| 0 |
| 119 |
| EG001 | Latanoprost | All participants while on latanoprost and during a post-latanoprost washout | 0 | 121 | 0 | 121 | 0 | 121 |
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| Left eye |
|
|
| t-test, 2 sided |
paired t test, 2 sided |
| 0.0001 |
| Median Difference (Final Values) |
| 0.9 |
| 2-Sided |
| 95 |
| 0.7 |
| 1.1 |
| Other |
| Right Eye, treated vs. untreated | t-test, 2 sided | paired t-test | 0.94 | Mean Difference (Final Values) | 0.01 | 2-Sided | 95 | -0.2 | 0.2 | Other |
| Left Eye, treated vs. untreated | t-test, 2 sided | paired t-test, 2 sided | 0.54 | Mean Difference (Final Values) | 0.05 | 2-Sided | 95 | -0.1 | 0.2 | Other |
| t-test, 2 sided |
paired t-test, 2 sided |
| 0.15 |
| Mean Difference (Final Values) |
| 0.2 |
| 2-Sided |
| 95 |
| -0.1 |
| 0.6 |
| Other |
| Right Eye, treated vs. untreated | t-test, 2 sided | paired t-test, 2 sided | 0.52 | Mean Difference (Final Values) | 0.1 | 2-Sided | 95 | -0.3 | 0.6 | Other |
| Left Eye, treated vs. untreated | t-test, 2 sided | paired t-test, 2 sided | 0.88 | Mean Difference (Final Values) | 0.03 | 2-Sided | 95 | -0.4 | 0.4 | Other |