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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03284853 -
Safety and Efficacy Study of PG324 (Netarsudil/Latanoprost 0.02% / 0.005%) Ophthalmic Solution Compared to GANFORT® Ophthalmic Solution in Open Angle Glaucoma or Ocular Hypertension
|
Phase 3 | |
| Completed |
NCT01157364 -
Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT06441643 -
Next Generation Rocklatan
|
Phase 2 | |
| Recruiting |
NCT02471105 -
Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml
|
Phase 4 | |
| Recruiting |
NCT02792803 -
A Comparison of Xalatan (Latanoprost) to Apo-latanoprost and Co-latanoprost in the Treatment of Glaucoma
|
Phase 4 | |
| Terminated |
NCT02801617 -
Non-inferiority of PRO-067 Ophthalmic Solution vs GAAP Ofteno® in Glaucoma or Ocular Hypertension
|
Phase 3 | |
| Completed |
NCT02558374 -
Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension
|
Phase 3 | |
| Completed |
NCT02628223 -
180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma
|
N/A | |
| Completed |
NCT02390245 -
Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study
|
N/A | |
| Completed |
NCT02993445 -
Effect of Alternate Therapies on Intraocular Pressure in Ocular Hypertension
|
N/A | |
| Completed |
NCT02246764 -
Study of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
|
Phase 3 | |
| Completed |
NCT02338362 -
Inhaled Corticosteroids: Effect on Intraocular Pressure in Patients With Controlled Glaucoma
|
Phase 4 | |
| Completed |
NCT01936389 -
A Prospective Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Exfoliation Syndrome and Ocular Hypertension or Glaucoma
|
Phase 2 | |
| Completed |
NCT02003547 -
A Single Centre Study to Evaluate 3 Ophthalmic Formulations in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT01995136 -
Investigation of Intraocular Pressure (IOP) Reduction Efficacy of Travoprost Ophthalmic Solution in Patients With Normal Tension Glaucoma
|
Phase 4 | |
| Completed |
NCT01693315 -
Multiple Dose-escalation Study of AMA0076 in Patients With Ocular Hypertension or Primary Open-angle Glaucoma
|
Phase 2 | |
| Completed |
NCT01664039 -
An Efficacy and Tolerability Study of TRAVATAN® Versus LUMIGAN®
|
Phase 4 | |
| Active, not recruiting |
NCT01430923 -
Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost
|
N/A | |
| Completed |
NCT01415401 -
Efficacy and Tolerability of AZARGA® as Replacement Therapy in Patients on COMBIGAN® Therapy in Canada
|
Phase 4 | |
| Completed |
NCT01426867 -
A Comfort Study of Brinzolamide 1% / Brimonidine 0.2% Fixed Combination, Brinzolamide 1% and Brimonidine 0.2%
|
Phase 2 |