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Evaluation of Safety and Efficacy of PDP-716

NCT ID: NCT03450629

Last Updated: 2022-02-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

682 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-13

Study Completion Date

2020-12-01

Brief Summary

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

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Detailed Description

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Conditions

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Open Angle Glaucoma Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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PDP-716

Group Type EXPERIMENTAL

Brimonidine Tartrate Ophthalmic Suspension

Intervention Type DRUG

PDP-716

Brimonidine Tartrate Ophthalmic Solution

Group Type ACTIVE_COMPARATOR

Brimonidine Tartrate Ophthalmic Solution

Intervention Type DRUG

Three Times Brimonidine Tartrate Ophthalmic Solution

Interventions

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Brimonidine Tartrate Ophthalmic Suspension

PDP-716

Intervention Type DRUG

Brimonidine Tartrate Ophthalmic Solution

Three Times Brimonidine Tartrate Ophthalmic Solution

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Pharma Advanced Research Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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SPARC Site 4

Chandler, Arizona, United States

Site Status

SPARC Site 5

Prescott, Arizona, United States

Site Status

SPARC Site 3

Sun City, Arizona, United States

Site Status

SPARC Site 38

Burbank, California, United States

Site Status

SPARC Site 44

Glendale, California, United States

Site Status

SPARC Site 45

Glendale, California, United States

Site Status

SPARC Site 43

Mission Hills, California, United States

Site Status

SPARC Site 1

Newport Beach, California, United States

Site Status

SPARC Site 14

Santa Barbara, California, United States

Site Status

SPARC Site 47

Torrance, California, United States

Site Status

SPARC Site 7

Colorado Springs, Colorado, United States

Site Status

SPARC Site 11

Coral Springs, Florida, United States

Site Status

SPARC Site 29

Deerfield Beach, Florida, United States

Site Status

SPARC Site 34

Fort Myers, Florida, United States

Site Status

SPARC Site 46

Hollywood, Florida, United States

Site Status

SPARC Site 21

Jacksonville, Florida, United States

Site Status

SPARC Site 35

Miami, Florida, United States

Site Status

SPARC Site 27

Miami, Florida, United States

Site Status

SPARC Site 10

Miami, Florida, United States

Site Status

SPARC Site 16

Miami, Florida, United States

Site Status

SPARC Site 19

Miami, Florida, United States

Site Status

SPARC Site 25

Miami, Florida, United States

Site Status

SPARC Site 41

Pompano Beach, Florida, United States

Site Status

SPARC Site 18

Tampa, Florida, United States

Site Status

SPARC Site 42

Atlanta, Georgia, United States

Site Status

SPARC Site 2

Morrow, Georgia, United States

Site Status

SPARC Site 22

Roswell, Georgia, United States

Site Status

SPARC Site 12

Chicago, Illinois, United States

Site Status

SPARC Site 23

Paducah, Kentucky, United States

Site Status

SPARC Site 40

Bowie, Maryland, United States

Site Status

SPARC Site 28

Kansas City, Missouri, United States

Site Status

SPARC Site 48

Kansas City, Missouri, United States

Site Status

SPARC Site 31

St Louis, Missouri, United States

Site Status

SPARC Site 15

Poughkeepsie, New York, United States

Site Status

SPARC Site 36

Rochester, New York, United States

Site Status

SPARC Site 30

Gastonia, North Carolina, United States

Site Status

SPARC Site 9

High Point, North Carolina, United States

Site Status

SPARC Site 17

Winston-Salem, North Carolina, United States

Site Status

SPARC Site 33

Fargo, North Dakota, United States

Site Status

SPARC Site 37

Cincinnati, Ohio, United States

Site Status

SPARC Site 8

Cleveland, Ohio, United States

Site Status

SPARC Site 24

Cranberry Township, Pennsylvania, United States

Site Status

SPARC Site 32

Memphis, Tennessee, United States

Site Status

SPARC Site 39

Houston, Texas, United States

Site Status

SPARC Site 13

Mission, Texas, United States

Site Status

SPARC Site 20

San Antonio, Texas, United States

Site Status

SPARC Site 26

Saint Albans, Vermont, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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CLR_16_33

Identifier Type: -

Identifier Source: org_study_id

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