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Trial record 11 of 50 for:    Recruiting Studies | Open Angle Glaucoma or Ocular Hypertension.

Evaluation of Safety and Efficacy of Brimonidine Tartrate Ophthalmic Suspension

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. Identifier: NCT03450629
Recruitment Status : Recruiting
First Posted : March 1, 2018
Last Update Posted : September 10, 2019
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited

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

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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 :
  1. Change from baseline in mean intraocular pressure [ Time Frame: Week 12 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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

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 identifier (NCT number): NCT03450629

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Contact: Head, Clinical development +1 (609) 720-5333

  Hide Study Locations
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United States, Arizona
SPARC Site 4 Recruiting
Chandler, Arizona, United States, 85225
Contact: Dr. Michael J. Depenbusch, MD    480-999-5458   
SPARC Site 5 Recruiting
Prescott, Arizona, United States, 86301
Contact: Dr. Steven Mortenson, MD    480-999-5458   
SPARC Site 3 Recruiting
Sun City, Arizona, United States, 85351
Contact: Dr. Gerald Walman, MD    480-999-5458   
United States, California
SPARC Site 1 Recruiting
Newport Beach, California, United States, 92663
Contact: Dr. David Loius Wirta, MS, MD, PhD    949-650-1863   
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   
United States, Florida
SPARC Site 11 Recruiting
Coral Springs, Florida, United States, 33067
Contact: Dr. Shailesh Gupta, MD, MBA, FACS    321-578-1144   
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   
SPARC Site 21 Recruiting
Jacksonville, Florida, United States, 32204
Contact: Dr. Mc Donald Frank, MD    904-366-3781 ext 2215   
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   
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   
United States, Georgia
SPARC Site 2 Recruiting
Morrow, Georgia, United States, 30260
Contact: Dr. Harvey Bruce Dubiner, MD    770- 968-8888 ext 267   
SPARC Site 22 Recruiting
Roswell, Georgia, United States, 30076
Contact: Dr. Day G. Douglas, MD    404-895-9257   
United States, Illinois
SPARC Site 12 Recruiting
Chicago, Illinois, United States, 60619
Contact: Dr. Dovilan Logan Wyatt, MD    407-963-9683   
United States, Kentucky
SPARC Site 23 Recruiting
Paducah, Kentucky, United States, 42001
Contact: Dr. Gillespie Mark, MD    480-999-5458   
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;,   
United States, Nevada
SPARC Site 6 Recruiting
Henderson, Nevada, United States, 89052
Contact: Dr. Todd Jackson, MD    480-999-5458   
United States, New York
SPARC Site 15 Recruiting
Poughkeepsie, New York, United States, 12603
Contact: Dr. Satish Modi, MD, FRCS ©, CPI    8544541025   
United States, North Carolina
SPARC Site 30 Recruiting
Gastonia, North Carolina, United States, 28054
Contact: Dr. Allf Bryan, MD   
SPARC Site 9 Recruiting
High Point, North Carolina, United States, 27262
Contact: Dr. Robert J. DaVanzo, MD, FACS    336-802-2255   
SPARC Site 17 Recruiting
Winston-Salem, North Carolina, United States, 27101
Contact: Dr. James David Branch, MD    480-999-5458   
United States, North Dakota
SPARC Site 33 Recruiting
Fargo, North Dakota, United States, 58103
Contact: Dr. Bregstrom , MD    701-478-0061   
United States, Ohio
SPARC Site 8 Recruiting
Cleveland, Ohio, United States, 44115
Contact: Dr. Marc Abrams, MD    216-937-2020   
United States, Pennsylvania
SPARC Site 24 Recruiting
Cranberry Township, Pennsylvania, United States, 16066
Contact: Dr. Christie C. William, MD    724-772-5640   
United States, Tennessee
SPARC Site 32 Recruiting
Memphis, Tennessee, United States, 38119
Contact: Dr. Mclaurin , MD    901-761-4620;;   
United States, Texas
SPARC Site 13 Recruiting
Mission, Texas, United States, 78572
Contact: Dr. Pankajkumar Gopaldas Shah, MD    210-591-1161   
SPARC Site 20 Recruiting
San Antonio, Texas, United States, 78215
Contact: Dr. Nagi Kundandeep, MD    909-762-4264   
United States, Vermont
SPARC Site 26 Recruiting
Saint Albans, Vermont, United States, 05478
Contact: Dr. Allison Karen, MD    802-527-7787   
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited

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Responsible Party: Sun Pharma Advanced Research Company Limited 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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glaucoma, Open-Angle
Ocular 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