Ocular Hypertension Clinical Trial
Official title:
A Randomized, Multi-Center, Investigator-Masked, Parallel Group, Equivalence Study of Once Daily Brimonidine Tartrate Ophthalmic Suspension Compared With Three Times Daily ALPHAGAN-P® in Subjects With Open Angle Glaucoma, or Ocular Hypertension
| Verified date | January 2022 |
| Source | Sun Pharma Advanced Research Company Limited |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The study will be conducted to evaluate the efficacy and safety of topical administration of PDP-716 compared with brimonidine tartrate ophthalmic solution.
| Status | Completed |
| Enrollment | 682 |
| Est. completion date | December 1, 2020 |
| Est. primary completion date | December 1, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 2 Years and older |
| Eligibility | Inclusion Criteria: 1. Be male or female, of 2 years of age or older 2. Have open-angle glaucoma or ocular hypertension in both the eyes 3. Be able and willing to follow study instructions and complete all required visits. Exclusion Criteria: 1. Females who are pregnant/lactating. 2. Have uncontrolled systemic disease which might interfere with the study 3. Any known allergy or sensitivity to the study medications or their components 4. Any other clinically relevant abnormality |
| Country | Name | City | State |
|---|---|---|---|
| United States | SPARC Site 42 | Atlanta | Georgia |
| United States | SPARC Site 40 | Bowie | Maryland |
| United States | SPARC Site 38 | Burbank | California |
| United States | SPARC Site 4 | Chandler | Arizona |
| United States | SPARC Site 12 | Chicago | Illinois |
| United States | SPARC Site 37 | Cincinnati | Ohio |
| United States | SPARC Site 8 | Cleveland | Ohio |
| United States | SPARC Site 7 | Colorado Springs | Colorado |
| United States | SPARC Site 11 | Coral Springs | Florida |
| United States | SPARC Site 24 | Cranberry Township | Pennsylvania |
| United States | SPARC Site 29 | Deerfield Beach | Florida |
| United States | SPARC Site 33 | Fargo | North Dakota |
| United States | SPARC Site 34 | Fort Myers | Florida |
| United States | SPARC Site 30 | Gastonia | North Carolina |
| United States | SPARC Site 44 | Glendale | California |
| United States | SPARC Site 45 | Glendale | California |
| United States | SPARC Site 9 | High Point | North Carolina |
| United States | SPARC Site 46 | Hollywood | Florida |
| United States | SPARC Site 39 | Houston | Texas |
| United States | SPARC Site 21 | Jacksonville | Florida |
| United States | SPARC Site 28 | Kansas City | Missouri |
| United States | SPARC Site 48 | Kansas City | Missouri |
| United States | SPARC Site 32 | Memphis | Tennessee |
| United States | SPARC Site 10 | Miami | Florida |
| United States | SPARC Site 16 | Miami | Florida |
| United States | SPARC Site 19 | Miami | Florida |
| United States | SPARC Site 25 | Miami | Florida |
| United States | SPARC Site 27 | Miami | Florida |
| United States | SPARC Site 35 | Miami | Florida |
| United States | SPARC Site 13 | Mission | Texas |
| United States | SPARC Site 43 | Mission Hills | California |
| United States | SPARC Site 2 | Morrow | Georgia |
| United States | SPARC Site 1 | Newport Beach | California |
| United States | SPARC Site 23 | Paducah | Kentucky |
| United States | SPARC Site 41 | Pompano Beach | Florida |
| United States | SPARC Site 15 | Poughkeepsie | New York |
| United States | SPARC Site 5 | Prescott | Arizona |
| United States | SPARC Site 36 | Rochester | New York |
| United States | SPARC Site 22 | Roswell | Georgia |
| United States | SPARC Site 26 | Saint Albans | Vermont |
| United States | SPARC Site 31 | Saint Louis | Missouri |
| United States | SPARC Site 20 | San Antonio | Texas |
| United States | SPARC Site 14 | Santa Barbara | California |
| United States | SPARC Site 3 | Sun City | Arizona |
| United States | SPARC Site 18 | Tampa | Florida |
| United States | SPARC Site 47 | Torrance | California |
| United States | SPARC Site 17 | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Sun Pharma Advanced Research Company Limited |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change From Baseline in Mean Intraocular Pressure | Week 12 8 AM, 10 AM and 4 PM |
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|---|---|---|---|
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