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Evaluation of Safety and Efficacy of PDP-716

Primary Purpose

Open Angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Brimonidine Tartrate Ophthalmic Suspension
Brimonidine Tartrate Ophthalmic Solution
Sponsored by
Sun Pharma Advanced Research Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open Angle Glaucoma

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • SPARC Site 4
  • SPARC Site 5
  • SPARC Site 3
  • SPARC Site 38
  • SPARC Site 44
  • SPARC Site 45
  • SPARC Site 43
  • SPARC Site 1
  • SPARC Site 14
  • SPARC Site 47
  • SPARC Site 7
  • SPARC Site 11
  • SPARC Site 29
  • SPARC Site 34
  • SPARC Site 46
  • SPARC Site 21
  • SPARC Site 35
  • SPARC Site 27
  • SPARC Site 10
  • SPARC Site 16
  • SPARC Site 19
  • SPARC Site 25
  • SPARC Site 41
  • SPARC Site 18
  • SPARC Site 42
  • SPARC Site 2
  • SPARC Site 22
  • SPARC Site 12
  • SPARC Site 23
  • SPARC Site 40
  • SPARC Site 28
  • SPARC Site 48
  • SPARC Site 31
  • SPARC Site 15
  • SPARC Site 36
  • SPARC Site 30
  • SPARC Site 9
  • SPARC Site 17
  • SPARC Site 33
  • SPARC Site 37
  • SPARC Site 8
  • SPARC Site 24
  • SPARC Site 32
  • SPARC Site 39
  • SPARC Site 13
  • SPARC Site 20
  • SPARC Site 26

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PDP-716

Brimonidine Tartrate Ophthalmic Solution

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Mean Intraocular Pressure

Secondary Outcome Measures

Full Information

First Posted
February 21, 2018
Last Updated
January 27, 2022
Sponsor
Sun Pharma Advanced Research Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT03450629
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 13, 2018 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Pharma Advanced Research Company Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
682 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PDP-716
Arm Type
Experimental
Arm Title
Brimonidine Tartrate Ophthalmic Solution
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Brimonidine Tartrate Ophthalmic Suspension
Intervention Description
PDP-716
Intervention Type
Drug
Intervention Name(s)
Brimonidine Tartrate Ophthalmic Solution
Intervention Description
Three Times Brimonidine Tartrate Ophthalmic Solution
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Intraocular Pressure
Time Frame
Week 12 8 AM, 10 AM and 4 PM

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
SPARC Site 4
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
Facility Name
SPARC Site 5
City
Prescott
State/Province
Arizona
ZIP/Postal Code
86301
Country
United States
Facility Name
SPARC Site 3
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
SPARC Site 38
City
Burbank
State/Province
California
ZIP/Postal Code
91506
Country
United States
Facility Name
SPARC Site 44
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
SPARC Site 45
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
SPARC Site 43
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
SPARC Site 1
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
SPARC Site 14
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93110
Country
United States
Facility Name
SPARC Site 47
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
SPARC Site 7
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80919
Country
United States
Facility Name
SPARC Site 11
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33067
Country
United States
Facility Name
SPARC Site 29
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
SPARC Site 34
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
SPARC Site 46
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
SPARC Site 21
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
SPARC Site 35
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
SPARC Site 27
City
Miami
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
SPARC Site 10
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
SPARC Site 16
City
Miami
State/Province
Florida
ZIP/Postal Code
33145
Country
United States
Facility Name
SPARC Site 19
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Facility Name
SPARC Site 25
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
SPARC Site 41
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33060
Country
United States
Facility Name
SPARC Site 18
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
SPARC Site 42
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30349
Country
United States
Facility Name
SPARC Site 2
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
SPARC Site 22
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
SPARC Site 12
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60619
Country
United States
Facility Name
SPARC Site 23
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42001
Country
United States
Facility Name
SPARC Site 40
City
Bowie
State/Province
Maryland
ZIP/Postal Code
20715
Country
United States
Facility Name
SPARC Site 28
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64055
Country
United States
Facility Name
SPARC Site 48
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64133
Country
United States
Facility Name
SPARC Site 31
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
SPARC Site 15
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12603
Country
United States
Facility Name
SPARC Site 36
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
SPARC Site 30
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Facility Name
SPARC Site 9
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
SPARC Site 17
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27101
Country
United States
Facility Name
SPARC Site 33
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
SPARC Site 37
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
SPARC Site 8
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44115
Country
United States
Facility Name
SPARC Site 24
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
SPARC Site 32
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
SPARC Site 39
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
SPARC Site 13
City
Mission
State/Province
Texas
ZIP/Postal Code
78572
Country
United States
Facility Name
SPARC Site 20
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
SPARC Site 26
City
Saint Albans
State/Province
Vermont
ZIP/Postal Code
05478
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Safety and Efficacy of PDP-716

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