Clinical trial NCT03450629: Evaluation of Safety and Efficacy of PDP-716
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Open Angle Glaucoma
Ocular Hypertension
Lead sponsor: Sun Pharma Advanced Research Company Limited
Sponsor class: INDUSTRY
First posted: 2018-03-01
Enrollment: 682
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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