Evaluation of Safety and Efficacy of PDP-716

Phase 3

Completed

Conditions: Open Angle Glaucoma
Ocular Hypertension

Interventions: Drug: Brimonidine Tartrate Ophthalmic Suspension
Drug: Brimonidine Tartrate Ophthalmic Solution

Registration Number: NCT03450629

Lead Sponsor: Sun Pharma Advanced Research Company Limited

Brief Summary: The study will be conducted to evaluate the efficacy and safety of topical administration of PDP-716 compared with brimonidine tartrate ophthalmic solution.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 682

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PDP-716	Brimonidine Tartrate Ophthalmic Suspension	-
Brimonidine Tartrate Ophthalmic Solution	Brimonidine Tartrate Ophthalmic Solution	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Intraocular Pressure	Week 12 8 AM, 10 AM and 4 PM

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (47): SPARC Site 27
🇺🇸
Miami, Florida, United States
SPARC Site 16
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Miami, Florida, United States
SPARC Site 38
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Burbank, California, United States
SPARC Site 1
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Newport Beach, California, United States
SPARC Site 10
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Miami, Florida, United States
SPARC Site 8
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Cleveland, Ohio, United States
SPARC Site 14
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Santa Barbara, California, United States
SPARC Site 29
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Deerfield Beach, Florida, United States
SPARC Site 19
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Miami, Florida, United States
SPARC Site 34
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Fort Myers, Florida, United States
SPARC Site 46
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Hollywood, Florida, United States
SPARC Site 42
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Atlanta, Georgia, United States
SPARC Site 23
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Paducah, Kentucky, United States
SPARC Site 37
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Cincinnati, Ohio, United States
SPARC Site 39
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Houston, Texas, United States
SPARC Site 25
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Miami, Florida, United States
SPARC Site 4
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Chandler, Arizona, United States
SPARC Site 5
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Prescott, Arizona, United States
SPARC Site 45
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Glendale, California, United States
SPARC Site 3
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Sun City, Arizona, United States
SPARC Site 44
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Glendale, California, United States
SPARC Site 7
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Colorado Springs, Colorado, United States
SPARC Site 47
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Torrance, California, United States
SPARC Site 43
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Mission Hills, California, United States
SPARC Site 11
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Coral Springs, Florida, United States
SPARC Site 21
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Jacksonville, Florida, United States
SPARC Site 35
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Miami, Florida, United States
SPARC Site 41
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Pompano Beach, Florida, United States
SPARC Site 2
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Morrow, Georgia, United States
SPARC Site 12
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Chicago, Illinois, United States
SPARC Site 40
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Bowie, Maryland, United States
SPARC Site 31
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Saint Louis, Missouri, United States
SPARC Site 15
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Poughkeepsie, New York, United States
SPARC Site 36
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Rochester, New York, United States
SPARC Site 9
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High Point, North Carolina, United States
SPARC Site 33
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Fargo, North Dakota, United States
SPARC Site 32
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Memphis, Tennessee, United States
SPARC Site 24
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Cranberry Township, Pennsylvania, United States
SPARC Site 13
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Mission, Texas, United States
SPARC Site 26
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Saint Albans, Vermont, United States
SPARC Site 22
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Roswell, Georgia, United States
SPARC Site 30
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Gastonia, North Carolina, United States
SPARC Site 17
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Winston-Salem, North Carolina, United States
SPARC Site 18
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Tampa, Florida, United States
SPARC Site 20
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San Antonio, Texas, United States
SPARC Site 28
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Kansas City, Missouri, United States
SPARC Site 48
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Kansas City, Missouri, United States