Evaluation of Safety and Efficacy of Brimonidine Tartrate Ophthalmic Suspension



Status:Recruiting
Conditions:High Blood Pressure (Hypertension), Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:2 - Any
Updated:2/28/2019
Start Date:September 13, 2018
End Date:October 2019
Contact:Sun Pharma Advanced Research Company Limited
Email:clinical.trials@sparcmail.com
Phone:+1 (609) 720-5333

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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

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.


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
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