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To analyze Cosopt® in terms of its effects on ocular perfusion pressure and comprehensive ocular blood flow and in relation to visual field progression and optic nerve structural changes in an ongoing 3 year prospective study involving 120 patients with open angle glaucoma.
To analyze Cosopt® in terms of its effects on ocular perfusion pressure and comprehensive ocular blood flow and in relation to visual field progression and optic nerve structural changes in an ongoing 3 year prospective study involving 120 patients with open angle glaucoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glaucoma patients | Patients with Glaucoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (Cosopt®, prostaglandin) | Drug | We did NOT provide any intervention, we observed groups of patients already on these drugs as observers only. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV) | Measurement of change in ocular blood flow - ophthalmic artery peak systolic velocity | Baseline and 6 month visits |
| 6-month Change inOphthalmic Artery (OA) End Diastolic Velocity (EDV) | Measurement of change in ocular blood flow - ophthalmic artery end diastolic velocity | Baseline and 6 month visits |
| 6-month Change in Ophthalmic Artery (OA) Vascular Resistance (RI) | Measurement of change in ocular blood flow - ophthalmic artery resistance index, this is a measure of the amount of resistance to blood flow within the selected blood vessel. | Baseline and 6 month visits |
| 6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV) | Measurement of change in ocular blood flow - central retinal arteries peak systolic velocity | Baseline and 6 month visits |
| 6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV) | Measurement of change in ocular blood flow - central retinal arteries end diastolic velocity | Baseline and 6 month visits |
| 6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI) | Measurement of change in ocular blood flow - central retinal arteries resistance index, this is a measure of the amount of resistance to blood flow within the selected blood vessel. | Baseline and 6 month visits |
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Inclusion Criteria:
Age: 30 years or older.
Diagnosis: confirmed open-angle glaucoma in at least one eye:
Best corrected visual acuity at least 20/60 in at least one eye.
Prior Humphrey visual fields demonstrate acceptable reliability standards.
Exclusion Criteria:
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Glaucoma patients
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| Name | Affiliation | Role |
|---|---|---|
| Alon Harris, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of Medicine, Department of Ophthalmology | Indianapolis | Indiana | 46202 | United States |
observational study, patients were treated by their physician not by study personel, treatments/interventions were self-reported by the patients, treatment was not necessarily started at glaucoma diagnosis
recruitment over 6 months. Hospital and area eye clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | Trusopt | Patients with glaucoma taking Trusopt or Cosopt alone or with prostaglandin for at least 6 months |
| FG001 | Prostaglandin Alone | Patients with glaucoma taking prostaglandin alone for at least 6 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6-month Treatment |
| |||||||||||||
| 3-year Treatment |
|
glaucoma patients:There will be (as shown) differences in the number of subjects based upon the time of analysis due to patient loss, data of insufficient quality at visit, or change in the drug use during period of study (patient switched off treatment by their doctor) so the number of data points varies throughout the analysis by availability.
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| ID | Title | Description |
|---|---|---|
| BG000 | Trusopt | Patients with glaucoma taking Trusopt or Cosopt alone or with prostaglandin for at least 6 months |
| BG001 | Prostaglandin Alone | Patients with glaucoma taking prostaglandin alone for at least 6 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | 6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV) | Measurement of change in ocular blood flow - ophthalmic artery peak systolic velocity | Posted | Mean | Standard Error | cm/sec | Baseline and 6 month visits |
|
|
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Adverse events were not assessed/collected as part of this study protocol.
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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 | Glaucoma Patients | Patients with Glaucoma |
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Small numbers of participants at various time-points limited the power of analysis in our estimation, as did patients who changed medications and therefore further limited analysis options at various time-points.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alon Harris | Indiana University | 317-278-00177 | alharris@indiana.edu |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D018450 | Disease Progression |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C479140 | dorzolamide-timolol combination |
| D011453 | Prostaglandins |
| D013999 | Timolol |
| ID | Term |
|---|---|
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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| 6-month Change in Ocular Perfusion Pressures (OPP) |
Measurement of change in ocular perfusion pressure, the pressure of blood flow to the eye minus the pressure of within the eye. |
| Baseline and 6 month visits |
| 3-year Change in OA PSV | Measurement of change in ocular blood flow - ophthalmic artery peak systolic velocity | Baseline and 36 month visits |
| 3-year Change in OA EDV | Measurement of change in ocular blood flow - ophthalmic artery end diastolic velocity | Baseline and 36 month visits |
| 3-year Change in OA RI | Measurement of change in ocular blood flow - ophthalmic artery resistance index | Baseline and 36 month visits |
| 3-year Change in CRA PSV | Measurement of change in ocular blood flow - central retinal arteries peak systolic velocity | Baseline and 36 month visits |
| 3-year Change in CRA EDV | Measurement of change in ocular blood flow - central retinal arteries end diastolic velocity | Baseline and 36 month visits |
| 3-year Change in CRA RI | Measurement of change in ocular blood flow - central retinal arteries resistance index | Baseline and 36 month visits |
| 3-year Change in OPP | Measurement of change in ocular perfusion pressure | Baseline and 36 month visits |
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
|
| Primary | 6-month Change inOphthalmic Artery (OA) End Diastolic Velocity (EDV) | Measurement of change in ocular blood flow - ophthalmic artery end diastolic velocity | Posted | Mean | Standard Error | cm/sec | Baseline and 6 month visits |
|
|
|
|
| Primary | 6-month Change in Ophthalmic Artery (OA) Vascular Resistance (RI) | Measurement of change in ocular blood flow - ophthalmic artery resistance index, this is a measure of the amount of resistance to blood flow within the selected blood vessel. | Posted | Mean | Standard Error | unitless | Baseline and 6 month visits |
|
|
|
|
| Primary | 6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV) | Measurement of change in ocular blood flow - central retinal arteries peak systolic velocity | Posted | Mean | Standard Error | cm/sec | Baseline and 6 month visits |
|
|
|
|
| Primary | 6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV) | Measurement of change in ocular blood flow - central retinal arteries end diastolic velocity | Posted | Mean | Standard Error | cm/sec | Baseline and 6 month visits |
|
|
|
|
| Primary | 6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI) | Measurement of change in ocular blood flow - central retinal arteries resistance index, this is a measure of the amount of resistance to blood flow within the selected blood vessel. | Posted | Mean | Standard Error | unitless | Baseline and 6 month visits |
|
|
|
|
| Primary | 6-month Change in Ocular Perfusion Pressures (OPP) | Measurement of change in ocular perfusion pressure, the pressure of blood flow to the eye minus the pressure of within the eye. | Posted | Mean | Standard Error | mm Hg | Baseline and 6 month visits |
|
|
|
|
| Primary | 3-year Change in OA PSV | Measurement of change in ocular blood flow - ophthalmic artery peak systolic velocity | Posted | Mean | Standard Error | cm/sec | Baseline and 36 month visits |
|
|
|
|
| Primary | 3-year Change in OA EDV | Measurement of change in ocular blood flow - ophthalmic artery end diastolic velocity | Posted | Mean | Standard Error | cm/sec | Baseline and 36 month visits |
|
|
|
|
| Primary | 3-year Change in OA RI | Measurement of change in ocular blood flow - ophthalmic artery resistance index | Posted | Mean | Standard Error | unitless | Baseline and 36 month visits |
|
|
|
|
| Primary | 3-year Change in CRA PSV | Measurement of change in ocular blood flow - central retinal arteries peak systolic velocity | Posted | Mean | Standard Error | cm/sec | Baseline and 36 month visits |
|
|
|
|
| Primary | 3-year Change in CRA EDV | Measurement of change in ocular blood flow - central retinal arteries end diastolic velocity | Posted | Mean | Standard Error | cm/sec | Baseline and 36 month visits |
|
|
|
|
| Primary | 3-year Change in CRA RI | Measurement of change in ocular blood flow - central retinal arteries resistance index | Posted | Mean | Standard Error | unitless | Baseline and 36 month visits |
|
|
|
|
| Primary | 3-year Change in OPP | Measurement of change in ocular perfusion pressure | Posted | Mean | Standard Error | mm Hg | Baseline and 36 month visits |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012898 |
| Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009025 | Morpholines |
| D010078 | Oxazines |