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OpenTrials
Completed

NCT Number: NCT03450629

Evaluation of Safety and Efficacy of PDP-716

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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Key information

Conditions

Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

SPARC Site 4, Chandler, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brimonidine Tartrate Ophthalmic Suspension

Drug

PDP-716

Brimonidine Tartrate Ophthalmic Solution

Drug

Three Times Brimonidine Tartrate Ophthalmic Solution

Primary outcomes

  1. Change From Baseline in Mean Intraocular Pressure

    Time frame: Week 12 8 AM, 10 AM and 4 PM

Sponsors and collaborators

Lead sponsor

Sun Pharma Advanced Research Company Limited

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 1, 2018
Registry last updated
Feb 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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