A Phase III, Randomized, Double-Masked, Active-Controlled, Parallel-Group, Multi-center 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 3 Study
Phase of Trial: Phase III
Latest Information Update: 26 Jun 2019
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At a glance
- Drugs Omidenepag isopropyl (Primary) ; Timolol
- Indications Glaucoma; Ocular hypertension
- Focus Registrational; Therapeutic Use
- Acronyms Spectrum 3
- Sponsors Santen Inc
- 24 Jun 2019 Planned End Date changed from 18 Jun 2020 to 30 Oct 2020.
- 24 Jun 2019 Planned primary completion date changed from 3 Feb 2020 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).