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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

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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

  Show 34 Study Locations
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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Brimonidine Tartrate
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
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