Evaluation of Safety and Efficacy of PDP-716

January 27, 2022 updated by: Sun Pharma Advanced Research Company Limited

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

682

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85225
        • SPARC Site 4
      • Prescott, Arizona, United States, 86301
        • SPARC Site 5
      • Sun City, Arizona, United States, 85351
        • SPARC Site 3
    • California
      • Burbank, California, United States, 91506
        • SPARC site 38
      • Glendale, California, United States, 91204
        • SPARC Site 44
      • Glendale, California, United States, 91204
        • SPARC site 45
      • Mission Hills, California, United States, 91345
        • SPARC Site 43
      • Newport Beach, California, United States, 92663
        • SPARC Site 1
      • Santa Barbara, California, United States, 93110
        • SPARC Site 14
      • Torrance, California, United States, 90505
        • SPARC site 47
    • Colorado
      • Colorado Springs, Colorado, United States, 80919
        • SPARC Site 7
    • Florida
      • Coral Springs, Florida, United States, 33067
        • SPARC Site 11
      • Deerfield Beach, Florida, United States, 33064
        • SPARC Site 29
      • Fort Myers, Florida, United States, 33901
        • SPARC Site 34
      • Hollywood, Florida, United States, 33021
        • SPARC Site 46
      • Jacksonville, Florida, United States, 32204
        • SPARC Site 21
      • Miami, Florida, United States, 33126
        • SPARC Site 35
      • Miami, Florida, United States, 33134
        • SPARC Site 27
      • Miami, Florida, United States, 33143
        • SPARC Site 10
      • Miami, Florida, United States, 33145
        • SPARC Site 16
      • Miami, Florida, United States, 33174
        • SPARC Site 19
      • Miami, Florida, United States, 33175
        • SPARC Site 25
      • Pompano Beach, Florida, United States, 33060
        • SPARC Site 41
      • Tampa, Florida, United States, 33603
        • SPARC Site 18
    • Georgia
      • Atlanta, Georgia, United States, 30349
        • SPARC Site 42
      • Morrow, Georgia, United States, 30260
        • SPARC Site 2
      • Roswell, Georgia, United States, 30076
        • SPARC Site 22
    • Illinois
      • Chicago, Illinois, United States, 60619
        • SPARC Site 12
    • Kentucky
      • Paducah, Kentucky, United States, 42001
        • SPARC Site 23
    • Maryland
      • Bowie, Maryland, United States, 20715
        • SPARC Site 40
    • Missouri
      • Kansas City, Missouri, United States, 64055
        • SPARC Site 28
      • Kansas City, Missouri, United States, 64133
        • SPARC Site 48
      • Saint Louis, Missouri, United States, 63128
        • SPARC Site 31
    • New York
      • Poughkeepsie, New York, United States, 12603
        • SPARC Site 15
      • Rochester, New York, United States, 14618
        • SPARC site 36
    • North Carolina
      • Gastonia, North Carolina, United States, 28054
        • SPARC Site 30
      • High Point, North Carolina, United States, 27262
        • SPARC Site 9
      • Winston-Salem, North Carolina, United States, 27101
        • SPARC Site 17
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • SPARC Site 33
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • SPARC Site 37
      • Cleveland, Ohio, United States, 44115
        • SPARC Site 8
    • Pennsylvania
      • Cranberry Township, Pennsylvania, United States, 16066
        • SPARC Site 24
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • SPARC Site 32
    • Texas
      • Houston, Texas, United States, 77008
        • SPARC site 39
      • Mission, Texas, United States, 78572
        • SPARC Site 13
      • San Antonio, Texas, United States, 78215
        • SPARC Site 20
    • Vermont
      • Saint Albans, Vermont, United States, 05478
        • SPARC Site 26

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PDP-716
Drug: Brimonidine Tartrate Ophthalmic Suspension
PDP-716
Active Comparator: Brimonidine Tartrate Ophthalmic Solution
Drug: Brimonidine Tartrate Ophthalmic Solution
Three Times Brimonidine Tartrate Ophthalmic Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Mean Intraocular Pressure
Time Frame: Week 12 8 AM, 10 AM and 4 PM
Week 12 8 AM, 10 AM and 4 PM

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Pharma Advanced Research Company Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2018

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

February 21, 2018

First Submitted That Met QC Criteria

February 28, 2018

First Posted (Actual)

March 1, 2018

Study Record Updates

Last Update Posted (Actual)

February 15, 2022

Last Update Submitted That Met QC Criteria

January 27, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLR_16_33

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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