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A Phase III, Randomized, Double-Masked, Active-Controlled, Parallel-Group, Multicenter Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 4 Study

Trial Profile

A Phase III, Randomized, Double-Masked, Active-Controlled, Parallel-Group, Multicenter Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 4 Study

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 26 Jun 2019

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At a glance

  • Drugs Omidenepag isopropyl (Primary)
  • Indications Glaucoma; Ocular hypertension
  • Focus Registrational; Therapeutic Use
  • Acronyms Spectrum 4
  • Sponsors Santen Inc
  • Most Recent Events

    • 24 Jun 2019 Planned End Date changed from 17 Oct 2019 to 31 Dec 2019.
    • 24 Jun 2019 Planned primary completion date changed from 3 Jun 2019 to 31 Dec 2019.
    • 22 Oct 2018 According to a Santen Inc media release, this trial is included under SPECTRUM program.The SPECTRUM program includes two pivotal, phase III trials, SPECTRUM 3 (NCT03691649) and SPECTRUM 4 (NCT03691662).
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