Trial record 11 of 50 for:
Recruiting Studies | Open Angle Glaucoma or Ocular Hypertension.
Evaluation of Safety and Efficacy of Brimonidine Tartrate Ophthalmic Suspension
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03450629 |
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Recruitment Status :
Recruiting
First Posted : March 1, 2018
Last Update Posted : September 10, 2019
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Sponsor:
Sun Pharma Advanced Research Company Limited
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited
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Brief Summary:
The study will be conducted to evaluate the efficacy and safety of topical administration of brimonidine tartrate ophthalmic suspension compared with brimonidine tartrate ophthalmic solution.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Open Angle Glaucoma Ocular Hypertension | Drug: Brimonidine Tartrate Ophthalmic Suspension Drug: Brimonidine Tartrate Ophthalmic Solution | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 666 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Investigator) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | September 13, 2018 |
| Estimated Primary Completion Date : | December 2019 |
| Estimated Study Completion Date : | April 2020 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Brimonidine Tartrate Ophthalmic Suspension |
Drug: Brimonidine Tartrate Ophthalmic Suspension
Brimonidine Tartrate Ophthalmic Suspension |
| Active Comparator: Brimonidine Tartrate Ophthalmic Solution |
Drug: Brimonidine Tartrate Ophthalmic Solution
Three Times Brimonidine Tartrate Ophthalmic Solution |
Primary Outcome Measures :
- Change from baseline in mean intraocular pressure [ Time Frame: Week 12 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 2 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Be male or female, of 2 years of age or older
- Have open-angle glaucoma or ocular hypertension in both the eyes
- Be able and willing to follow study instructions and complete all required visits.
Exclusion Criteria:
- Females who are pregnant/lactating.
- Have uncontrolled systemic disease which might interfere with the study
- Any known allergy or sensitivity to the study medications or their components
- Any other clinically relevant abnormality
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03450629
Contacts
| Contact: Head, Clinical development | +1 (609) 720-5333 | clinical.trials@sparcmail.com |
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Locations
| United States, Arizona | |
| SPARC Site 4 | Recruiting |
| Chandler, Arizona, United States, 85225 | |
| Contact: Dr. Michael J. Depenbusch, MD 480-999-5458 michael.depenbusch@doctrials.com | |
| SPARC Site 5 | Recruiting |
| Prescott, Arizona, United States, 86301 | |
| Contact: Dr. Steven Mortenson, MD 480-999-5458 steve.mortenson@doctrials.com | |
| SPARC Site 3 | Recruiting |
| Sun City, Arizona, United States, 85351 | |
| Contact: Dr. Gerald Walman, MD 480-999-5458 gerald.walman@doctrials.com | |
| United States, California | |
| SPARC Site 1 | Recruiting |
| Newport Beach, California, United States, 92663 | |
| Contact: Dr. David Loius Wirta, MS, MD, PhD 949-650-1863 david.wirta@drwirta.com | |
| SPARC Site 14 | Suspended |
| Santa Barbara, California, United States, 93110 | |
| United States, Colorado | |
| SPARC Site 7 | Recruiting |
| Colorado Springs, Colorado, United States, 80919 | |
| Contact: Dr. Michael G. Haas, MD 480-999-5458 erin.fox@doctrials.com | |
| United States, Florida | |
| SPARC Site 11 | Recruiting |
| Coral Springs, Florida, United States, 33067 | |
| Contact: Dr. Shailesh Gupta, MD, MBA, FACS 321-578-1144 sgupta1997@yahoo.com | |
| SPARC Site 29 | Recruiting |
| Deerfield Beach, Florida, United States, 33064 | |
| Contact: Dr. Rand , MD 954-782-1700 | |
| SPARC Site 34 | Recruiting |
| Fort Myers, Florida, United States, 33901 | |
| Contact: Dr. Smith , MD 239-939-0413 ext 325 Gmarinell@easwfl.com | |
| SPARC Site 21 | Recruiting |
| Jacksonville, Florida, United States, 32204 | |
| Contact: Dr. Mc Donald Frank, MD 904-366-3781 ext 2215 vontrece@gmail.com | |
| SPARC Site 27 | Recruiting |
| Miami, Florida, United States, 33134 | |
| Contact: Dr. Beraja , MD 786-899-2516 | |
| SPARC Site 10 | Recruiting |
| Miami, Florida, United States, 33143 | |
| Contact: Dr. Zachary Kaufman Segal, MD, PA 305-661-8588 ext 1810 zsegalmd@medeyeassociates.com | |
| SPARC Site 16 | Suspended |
| Miami, Florida, United States, 33145 | |
| SPARC Site 19 | Suspended |
| Miami, Florida, United States, 33174 | |
| SPARC Site 25 | Recruiting |
| Miami, Florida, United States, 33175 | |
| Contact: Dr. Ortiz Rafael, MD 305-220-2626 | |
| SPARC Site 18 | Recruiting |
| Tampa, Florida, United States, 33603 | |
| Contact: Dr. Don Perez-Ortiz, MD 813-875-6588 donp@irctampa.com | |
| United States, Georgia | |
| SPARC Site 2 | Recruiting |
| Morrow, Georgia, United States, 30260 | |
| Contact: Dr. Harvey Bruce Dubiner, MD 770- 968-8888 ext 267 glaucdocga@gmail.com | |
| SPARC Site 22 | Recruiting |
| Roswell, Georgia, United States, 30076 | |
| Contact: Dr. Day G. Douglas, MD 404-895-9257 dday@coastalresearchassociates.com | |
| United States, Illinois | |
| SPARC Site 12 | Recruiting |
| Chicago, Illinois, United States, 60619 | |
| Contact: Dr. Dovilan Logan Wyatt, MD 407-963-9683 dovilanwyatty@gmail.com | |
| United States, Kentucky | |
| SPARC Site 23 | Recruiting |
| Paducah, Kentucky, United States, 42001 | |
| Contact: Dr. Gillespie Mark, MD 480-999-5458 docmyeye@yahoo.com | |
| United States, Missouri | |
| SPARC Site 28 | Recruiting |
| Kansas City, Missouri, United States, 64055 | |
| Contact: Dr. Pikey , MD 913-261-2020 | |
| SPARC Site 31 | Recruiting |
| Saint Louis, Missouri, United States, 63128 | |
| Contact: Dr. Tekwani Navin, MD 314-842-2020 aprunty.tvc@gmail.com;ldinsmore.tvc@gmail.com, Lasiklisa2020@gmail.com | |
| United States, Nevada | |
| SPARC Site 6 | Recruiting |
| Henderson, Nevada, United States, 89052 | |
| Contact: Dr. Todd Jackson, MD 480-999-5458 todd.jackson@doctrials.com | |
| United States, New York | |
| SPARC Site 15 | Recruiting |
| Poughkeepsie, New York, United States, 12603 | |
| Contact: Dr. Satish Modi, MD, FRCS ©, CPI 8544541025 smodieyes@aol.com | |
| United States, North Carolina | |
| SPARC Site 30 | Recruiting |
| Gastonia, North Carolina, United States, 28054 | |
| Contact: Dr. Allf Bryan, MD c.reynolds@crgastonia.com | |
| SPARC Site 9 | Recruiting |
| High Point, North Carolina, United States, 27262 | |
| Contact: Dr. Robert J. DaVanzo, MD, FACS 336-802-2255 robert.davanzo@cornerstonehealthcare.comrdavanzo@wakehealth.edu | |
| SPARC Site 17 | Recruiting |
| Winston-Salem, North Carolina, United States, 27101 | |
| Contact: Dr. James David Branch, MD 480-999-5458 jdbresearch@hotmail.com | |
| United States, North Dakota | |
| SPARC Site 33 | Recruiting |
| Fargo, North Dakota, United States, 58103 | |
| Contact: Dr. Bregstrom , MD 701-478-0061 kristen@bergstromeye.com | |
| United States, Ohio | |
| SPARC Site 8 | Recruiting |
| Cleveland, Ohio, United States, 44115 | |
| Contact: Dr. Marc Abrams, MD 216-937-2020 marc.a.abrams@gmail.com | |
| United States, Pennsylvania | |
| SPARC Site 24 | Recruiting |
| Cranberry Township, Pennsylvania, United States, 16066 | |
| Contact: Dr. Christie C. William, MD 724-772-5640 WChristieMD@aol.com | |
| United States, Tennessee | |
| SPARC Site 32 | Recruiting |
| Memphis, Tennessee, United States, 38119 | |
| Contact: Dr. Mclaurin , MD 901-761-4620 tneyedoc@mac.com; dashe6060tec@gmail.com; totaleyecare6060@yahoo.com | |
| United States, Texas | |
| SPARC Site 13 | Recruiting |
| Mission, Texas, United States, 78572 | |
| Contact: Dr. Pankajkumar Gopaldas Shah, MD 210-591-1161 doctags@yahoo.com | |
| SPARC Site 20 | Recruiting |
| San Antonio, Texas, United States, 78215 | |
| Contact: Dr. Nagi Kundandeep, MD 909-762-4264 knagi@saeye.com | |
| United States, Vermont | |
| SPARC Site 26 | Recruiting |
| Saint Albans, Vermont, United States, 05478 | |
| Contact: Dr. Allison Karen, MD 802-527-7787 kallisonmdpc@gmail.com | |
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited
| Responsible Party: | Sun Pharma Advanced Research Company Limited |
| ClinicalTrials.gov Identifier: | NCT03450629 History of Changes |
| Other Study ID Numbers: |
CLR_16_33 |
| First Posted: | March 1, 2018 Key Record Dates |
| Last Update Posted: | September 10, 2019 |
| Last Verified: | September 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
|
Glaucoma Glaucoma, Open-Angle Ocular Hypertension Hypertension Eye Diseases Vascular Diseases Cardiovascular Diseases Brimonidine Tartrate Ophthalmic Solutions |
Pharmaceutical Solutions Antihypertensive Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |