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The study will be conducted to evaluate the efficacy and safety of topical administration of PDP-716 compared with brimonidine tartrate ophthalmic solution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PDP-716 | Experimental |
| |
| Brimonidine Tartrate Ophthalmic Solution | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brimonidine Tartrate Ophthalmic Suspension | Drug | PDP-716 |
| |
| Brimonidine Tartrate Ophthalmic Solution |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Intraocular Pressure | Week 12 8 AM, 10 AM and 4 PM |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SPARC Site 4 | Chandler | Arizona | 85225 | United States | ||
| SPARC Site 5 |
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| ID | Title | Description |
|---|---|---|
| FG000 | PDP-716 | Brimonidine tartrate 0.35% ophthalmic suspension (SPARC), QD |
| FG001 | Brimonidine Tartrate Ophthalmic Solution | Brimonidine tartrate 0.1% ophthalmic solution (Alphagan P® 0.1%), TID |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 20, 2018 | Nov 30, 2021 |
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| Drug |
Three Times Brimonidine Tartrate Ophthalmic Solution |
|
| Prescott |
| Arizona |
| 86301 |
| United States |
| SPARC Site 3 | Sun City | Arizona | 85351 | United States |
| SPARC Site 38 | Burbank | California | 91506 | United States |
| SPARC Site 44 | Glendale | California | 91204 | United States |
| SPARC Site 45 | Glendale | California | 91204 | United States |
| SPARC Site 43 | Mission Hills | California | 91345 | United States |
| SPARC Site 1 | Newport Beach | California | 92663 | United States |
| SPARC Site 14 | Santa Barbara | California | 93110 | United States |
| SPARC Site 47 | Torrance | California | 90505 | United States |
| SPARC Site 7 | Colorado Springs | Colorado | 80919 | United States |
| SPARC Site 11 | Coral Springs | Florida | 33067 | United States |
| SPARC Site 29 | Deerfield Beach | Florida | 33064 | United States |
| SPARC Site 34 | Fort Myers | Florida | 33901 | United States |
| SPARC Site 46 | Hollywood | Florida | 33021 | United States |
| SPARC Site 21 | Jacksonville | Florida | 32204 | United States |
| SPARC Site 35 | Miami | Florida | 33126 | United States |
| SPARC Site 27 | Miami | Florida | 33134 | United States |
| SPARC Site 10 | Miami | Florida | 33143 | United States |
| SPARC Site 16 | Miami | Florida | 33145 | United States |
| SPARC Site 19 | Miami | Florida | 33174 | United States |
| SPARC Site 25 | Miami | Florida | 33175 | United States |
| SPARC Site 41 | Pompano Beach | Florida | 33060 | United States |
| SPARC Site 18 | Tampa | Florida | 33603 | United States |
| SPARC Site 42 | Atlanta | Georgia | 30349 | United States |
| SPARC Site 2 | Morrow | Georgia | 30260 | United States |
| SPARC Site 22 | Roswell | Georgia | 30076 | United States |
| SPARC Site 12 | Chicago | Illinois | 60619 | United States |
| SPARC Site 23 | Paducah | Kentucky | 42001 | United States |
| SPARC Site 40 | Bowie | Maryland | 20715 | United States |
| SPARC Site 28 | Kansas City | Missouri | 64055 | United States |
| SPARC Site 48 | Kansas City | Missouri | 64133 | United States |
| SPARC Site 31 | St Louis | Missouri | 63128 | United States |
| SPARC Site 15 | Poughkeepsie | New York | 12603 | United States |
| SPARC Site 36 | Rochester | New York | 14618 | United States |
| SPARC Site 30 | Gastonia | North Carolina | 28054 | United States |
| SPARC Site 9 | High Point | North Carolina | 27262 | United States |
| SPARC Site 17 | Winston-Salem | North Carolina | 27101 | United States |
| SPARC Site 33 | Fargo | North Dakota | 58103 | United States |
| SPARC Site 37 | Cincinnati | Ohio | 45242 | United States |
| SPARC Site 8 | Cleveland | Ohio | 44115 | United States |
| SPARC Site 24 | Cranberry Township | Pennsylvania | 16066 | United States |
| SPARC Site 32 | Memphis | Tennessee | 38119 | United States |
| SPARC Site 39 | Houston | Texas | 77008 | United States |
| SPARC Site 13 | Mission | Texas | 78572 | United States |
| SPARC Site 20 | San Antonio | Texas | 78215 | United States |
| SPARC Site 26 | Saint Albans | Vermont | 05478 | United States |
| COMPLETED | Completed Visit 5 |
|
| NOT COMPLETED |
|
|
Safety Population
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| ID | Title | Description |
|---|---|---|
| BG000 | PDP-716 | Brimonidine Tartrate Ophthalmic Suspension |
| BG001 | Brimonidine Tartrate Ophthalmic Solution | Brimonidine Tartrate Ophthalmic Solution: Three Times Brimonidine Tartrate Ophthalmic Solution |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | Change From Baseline in Mean Intraocular Pressure | Per-Protocol Population | Posted | Mean | Standard Deviation | mmHg | Week 12 8 AM, 10 AM and 4 PM |
|
|
|
|
12 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 | PDP-716 | Brimonidine Tartrate Ophthalmic Suspension | 0 | 337 | 1 | 337 | 63 | 337 |
| EG001 | Brimonidine Tartrate Ophthalmic Solution | Brimonidine Tartrate Ophthalmic Solution: Three Times Brimonidine Tartrate Ophthalmic Solution | 0 | 341 | 3 | 341 | 38 | 341 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Coronary artery disease | Cardiac disorders | Systematic Assessment |
| ||
| Palpitations | Cardiac disorders | Systematic Assessment |
| ||
| Large cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | Systematic Assessment |
| ||
| Conjunctival hyperaemia | Eye disorders | Systematic Assessment |
| ||
| Conjunctivitis | Infections and infestations | Systematic Assessment |
| ||
| Vision blurred | Eye disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head, Clinical Developmnt | Sun Pharma Advanced Research Company Limited | 912266455645 | clinical.trials@sparcmail.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 22, 2021 | Nov 30, 2021 | SAP_001.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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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 4 PM +/- 30 min |
|
| Equivalence |
10 AM +/- 30 min |
| t-test, 2 sided | 0.0002 | Equivalence | 4 PM +/- 30 min |