Evaluation of Safety and Efficacy of PDP-716
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
1 other identifier
interventional
682
1 country
47
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2018
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2018
CompletedFirst Posted
Study publicly available on registry
March 1, 2018
CompletedStudy Start
First participant enrolled
September 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedResults Posted
Study results publicly available
February 15, 2022
CompletedFebruary 15, 2022
January 1, 2022
2.2 years
February 21, 2018
November 30, 2021
January 27, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Mean Intraocular Pressure
Week 12 8 AM, 10 AM and 4 PM
Study Arms (2)
PDP-716
EXPERIMENTALBrimonidine Tartrate Ophthalmic Solution
ACTIVE COMPARATORInterventions
Three Times Brimonidine Tartrate Ophthalmic Solution
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
SPARC Site 4
Chandler, Arizona, 85225, United States
SPARC Site 5
Prescott, Arizona, 86301, United States
SPARC Site 3
Sun City, Arizona, 85351, United States
SPARC Site 38
Burbank, California, 91506, United States
SPARC Site 44
Glendale, California, 91204, United States
SPARC Site 45
Glendale, California, 91204, United States
SPARC Site 43
Mission Hills, California, 91345, United States
SPARC Site 1
Newport Beach, California, 92663, United States
SPARC Site 14
Santa Barbara, California, 93110, United States
SPARC Site 47
Torrance, California, 90505, United States
SPARC Site 7
Colorado Springs, Colorado, 80919, United States
SPARC Site 11
Coral Springs, Florida, 33067, United States
SPARC Site 29
Deerfield Beach, Florida, 33064, United States
SPARC Site 34
Fort Myers, Florida, 33901, United States
SPARC Site 46
Hollywood, Florida, 33021, United States
SPARC Site 21
Jacksonville, Florida, 32204, United States
SPARC Site 35
Miami, Florida, 33126, United States
SPARC Site 27
Miami, Florida, 33134, United States
SPARC Site 10
Miami, Florida, 33143, United States
SPARC Site 16
Miami, Florida, 33145, United States
SPARC Site 19
Miami, Florida, 33174, United States
SPARC Site 25
Miami, Florida, 33175, United States
SPARC Site 41
Pompano Beach, Florida, 33060, United States
SPARC Site 18
Tampa, Florida, 33603, United States
SPARC Site 42
Atlanta, Georgia, 30349, United States
SPARC Site 2
Morrow, Georgia, 30260, United States
SPARC Site 22
Roswell, Georgia, 30076, United States
SPARC Site 12
Chicago, Illinois, 60619, United States
SPARC Site 23
Paducah, Kentucky, 42001, United States
SPARC Site 40
Bowie, Maryland, 20715, United States
SPARC Site 28
Kansas City, Missouri, 64055, United States
SPARC Site 48
Kansas City, Missouri, 64133, United States
SPARC Site 31
St Louis, Missouri, 63128, United States
SPARC Site 15
Poughkeepsie, New York, 12603, United States
SPARC Site 36
Rochester, New York, 14618, United States
SPARC Site 30
Gastonia, North Carolina, 28054, United States
SPARC Site 9
High Point, North Carolina, 27262, United States
SPARC Site 17
Winston-Salem, North Carolina, 27101, United States
SPARC Site 33
Fargo, North Dakota, 58103, United States
SPARC Site 37
Cincinnati, Ohio, 45242, United States
SPARC Site 8
Cleveland, Ohio, 44115, United States
SPARC Site 24
Cranberry Township, Pennsylvania, 16066, United States
SPARC Site 32
Memphis, Tennessee, 38119, United States
SPARC Site 39
Houston, Texas, 77008, United States
SPARC Site 13
Mission, Texas, 78572, United States
SPARC Site 20
San Antonio, Texas, 78215, United States
SPARC Site 26
Saint Albans, Vermont, 05478, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Head, Clinical Developmnt
- Organization
- Sun Pharma Advanced Research Company Limited
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2018
First Posted
March 1, 2018
Study Start
September 13, 2018
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
February 15, 2022
Results First Posted
February 15, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share