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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001082 | U.S. NIH Grant/Contract | View source |
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The aim of this study will be to determine the effects of pilocarpine as an adjunct medication to latanoprost monotherapy at multiple intervals throughout a 24-hour period and compare these effects to latanoprost alone.
This study plans to learn more about the effect of pilocarpine on intraocular pressure and ocular perfusion pressure for a full twenty-four hour period.
In this study, the investigators seek to better characterize the knowledge base of the intraocular pressure (IOP) lowering effects of pilocarpine in patients with open angle glaucoma or ocular hypertension who are currently taking latanoprost. The goal is to define the potential additive effect of pilocarpine throughout a 24-hour period, not only for IOP, but for ocular perfusion pressure (defined as 2/3[diastolicBP + 1/3(systolicBP - diastolicBP)] - IOP). These data will allow to expand current knowledge of the effects of pilocarpine and help determine if this medication has a useful role as an adjunctive treatment in glaucoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pilocarpine group | Experimental | Subjects with open-angle glaucoma and ocular hypertension that are currently taking latanoprost |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pilocarpine | Drug | Pilocarpine will be administered 4 times in addition to latanoprost. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Intraocular Pressure From Baseline at Visit 3 | Subjects will be enrolled at the first visit. Patients already on latanoprost may proceed immediately with the second visit. Patients on a different prostaglandin analog medication will be switched to latanoprost for at least 6 weeks. At second visit, intraocular pressure and blood pressure will be measured every 2 hours for a 24-hour period. At any point over the next 4 weeks, another 24-hour visit will be performed. This time, a dose of pilocarpine 2% will be administered at 4 different times in addition to the latanoprost . As before, intraocular pressure and blood pressure will be measured every 2 hours. After visit 3, subjects will return to their prior treatment regimen. Change in the intraocular pressure from the second and the third visit will be determined. 8 diurnal readings and 4 nocturnal readings were averaged separately during both Visit 2 for the PGA Monotherapy and Visit 3 for Pilocarpine+PGA | Two 24-hour visits: Baseline/Visit 2; Up to week 4/Visit 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ocular Perfusion Pressure | Ocular perfusion pressure will calculated from the intraocular pressure and blood pressure measurements. At Baseline/Visit 2, intraocular pressure and blood pressure will be measured every 2 hours for a 24-hour period. At any point over the next 4 weeks, another 24-hour visit (Visit 3) will be performed. This time, a dose of pilocarpine 2% will be administered at 4 different times in addition to the latanoprost (PGA monotherapy). As before, intraocular pressure and blood pressure will be measured every 2 hours. 8 diurnal readings and 4 nocturnal readings were averaged separately during both Visit 2 for the PGA Monotherapy and Visit 3 for Pilocarpine+PGA |
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Inclusion Criteria:
Current confirmed diagnosis of:
Current use of topical latanoprost once a day in both eyes for at least 6 weeks
any race/ethnicity
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leonard Seibold, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver Eye Hospital | Denver | Colorado | 80045 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pilocarpine Group | Subjects with open-angle glaucoma and ocular hypertension. Pilocarpine: Pilocarpine will be administered 4 times in addition to latanoprost. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pilocarpine Group | Subjects with open-angle glaucoma and ocular hypertension. Pilocarpine: Pilocarpine will be administered 4 times in addition to latanoprost. |
| 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 | Change in Intraocular Pressure From Baseline at Visit 3 | Subjects will be enrolled at the first visit. Patients already on latanoprost may proceed immediately with the second visit. Patients on a different prostaglandin analog medication will be switched to latanoprost for at least 6 weeks. At second visit, intraocular pressure and blood pressure will be measured every 2 hours for a 24-hour period. At any point over the next 4 weeks, another 24-hour visit will be performed. This time, a dose of pilocarpine 2% will be administered at 4 different times in addition to the latanoprost . As before, intraocular pressure and blood pressure will be measured every 2 hours. After visit 3, subjects will return to their prior treatment regimen. Change in the intraocular pressure from the second and the third visit will be determined. 8 diurnal readings and 4 nocturnal readings were averaged separately during both Visit 2 for the PGA Monotherapy and Visit 3 for Pilocarpine+PGA | Patients who are using a prostaglandin analog (PGA) will be monitored at visit two. At visit 3, pilocarpine will be added four times per day to the PGA therapy. | Posted | Mean | Standard Error | mmHg | Two 24-hour visits: Baseline/Visit 2; Up to week 4/Visit 3 |
1 month
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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 | Pilocarpine Group | Subjects with open-angle glaucoma, ocular hypertension or pseudoexfoliation glaucoma. Pilocarpine: Pilocarpine will be administered 4 times in addition to latanoprost. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachel Gerle | University of Colorado | 720-848-5096 | rachel.gerle@ucdenver.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 10, 2017 | Jun 21, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D010862 | Pilocarpine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Two 24-hour visits: Baseline/Visit 2; Up to week 4/Visit 3 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Diagnosis | Count of Participants | Participants |
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| Lens Status | Count of Participants | Participants |
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| Prior Laser Surgery | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | Pilocarpine Group | Subjects with open-angle glaucoma, ocular hypertension or pseudoexfoliation glaucoma. Pilocarpine: Pilocarpine will be administered 4 times in addition to latanoprost or brimonidine |
|
|
| Secondary | Change in Ocular Perfusion Pressure | Ocular perfusion pressure will calculated from the intraocular pressure and blood pressure measurements. At Baseline/Visit 2, intraocular pressure and blood pressure will be measured every 2 hours for a 24-hour period. At any point over the next 4 weeks, another 24-hour visit (Visit 3) will be performed. This time, a dose of pilocarpine 2% will be administered at 4 different times in addition to the latanoprost (PGA monotherapy). As before, intraocular pressure and blood pressure will be measured every 2 hours. 8 diurnal readings and 4 nocturnal readings were averaged separately during both Visit 2 for the PGA Monotherapy and Visit 3 for Pilocarpine+PGA | Patients who are using a prostaglandin analog (PGA) will be monitored at visit two. At visit 3, pilocarpine will be added four times per day to the PGA therapy. | Posted | Mean | Standard Deviation | mmHg | Two 24-hour visits: Baseline/Visit 2; Up to week 4/Visit 3 |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | PGA Monotherapy | Subjects with open-angle glaucoma, ocular hypertension or pseudoexfoliation glaucoma. PGA: Latanoprost or Bimatoprost administered one time per day. | 0 | 27 | 0 | 27 | 0 | 27 |
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| Visit 2: Nocturnal Systolic Blood Pressure |
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| Visit 3: Diurnal Ocular Perfusion Pressure |
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| Visit 3: Nocturnal Ocular Profusion Pressure |
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| Visit 3: Diurnal Systolic Blood Pressure |
|
| Visit 3: Nocturnal Systolic Blood Pressure |
|