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 : November 14, 2018
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

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 : March 2019
Estimated Study Completion Date : June 2019

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

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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

Contact: Sun Pharma Advanced Research Company Limited 91226645 5645

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 Active, not recruiting
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 Not yet recruiting
Coral Springs, Florida, United States, 33067
Contact: Dr. Shailesh Gupta, MD, MBA, FACS    321-578-1144   
SPARC Site 10 Active, not recruiting
Miami, Florida, United States, 33143
SPARC Site 16 Recruiting
Miami, Florida, United States, 33145
Contact: Dr. Armando Alegret, MD    786-487-3987   
SPARC Site 19 Not yet recruiting
Miami, Florida, United States, 33174
Contact: Dr. Adriana Gonzalez, MD    608-664-9000 ext 2289   
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   
United States, Illinois
SPARC Site 12 Not yet recruiting
Chicago, Illinois, United States, 60619
Contact: Dr. Dovilan Logan Wyatt, MD    407-963-9683   
United States, Nevada
SPARC Site 6 Active, not recruiting
Henderson, Nevada, United States, 89052
United States, New York
SPARC Site 15 Not yet recruiting
Poughkeepsie, New York, United States, 12603
Contact: Dr. Satish Modi, MD, FRCS ©, CPI    8544541025   
United States, North Carolina
SPARC Site 9 Not yet 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, Ohio
SPARC Site 8 Recruiting
Cleveland, Ohio, United States, 44115
Contact: Dr. Marc Abrams, MD    216-937-2020   
United States, Texas
SPARC Site 13 Not yet recruiting
Mission, Texas, United States, 78572
Contact: Dr. Pankajkumar Gopaldas Shah, MD    210-591-1161   
SPARC Site 20 Not yet recruiting
San Antonio, Texas, United States, 78215
Contact: Dr. Nagi , MD    909-762-4264   
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited

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: November 14, 2018
Last Verified: November 2018
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, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Brimonidine Tartrate
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