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A Phase II Clinical Study to Evaluate the Safety and Efficacy of PPP003 Ophthalmic Solution for the Treatment of Painful Dry Eye

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Trial Profile

A Phase II Clinical Study to Evaluate the Safety and Efficacy of PPP003 Ophthalmic Solution for the Treatment of Painful Dry Eye

Status: Planning
Phase of Trial: Phase II

Latest Information Update: 24 Jun 2019

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At a glance

  • Drugs Onternabez (Primary)
  • Indications Dry eyes; Ocular pain
  • Focus Therapeutic Use
  • Sponsors Tetra Bio Pharma

Most Recent Events

  • 24 Jun 2019 New trial record
  • 17 Jun 2019 According to a Tetra Bio Pharma media release, the FDA confirmed the proposed quality information requirements for initiating this trial.This included a container closure system, stability plans, drug substance and drug product specifications. The FDA also provided feedback on the GLP toxicology requirements to initiate this study.The FDA reviewed this proposed Phase II clinical study and agreed that it was acceptable and also provided guidance on acceptable primary and secondary endpoints.
  • 17 Jun 2019 According to a Tetra Bio Pharma media release, the company had conducted a Type B meeting with the United States Food and Drug Administration (FDA) for its non-controlled cannabinoid drug product PPP003 slated for the treatment of painful dry eye. The purpose of the meeting was to obtain confirmation of this phase II clinical study design and the quality and toxicology requirements for initiating this trial in patients in the USA.

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