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Randomized, Parallel Arm, Double-Masked, Placebo-Controlled Study of the Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis in Healthy Subjects

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Trial Profile

Randomized, Parallel Arm, Double-Masked, Placebo-Controlled Study of the Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis in Healthy Subjects

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Oct 2024

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At a glance

  • Drugs Phentolamine (Primary) ; Hydroxyamfetamine; Phenylephrine; Tropicamide
  • Indications Mydriasis
  • Focus Registrational; Therapeutic Use
  • Acronyms MIRA-2
  • Sponsors Ocuphire Pharma

Most Recent Events

  • 30 Sep 2024 According to an Ocuphire Pharma media release, company announced the publication of full results from this trial in the peer-reviewed journal Ophthalmology.
  • 27 Sep 2023 According to an Ocuphire Pharma media release, the U.S. Food and Drug Administration (FDA) has approved RYZUMVI (phentolamine ophthalmic solution) 0.75% for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents
  • 07 Sep 2023 According to an Ocuphire Pharma media release, data from this study will be presented at the 2023 European Society of Cataract and Refractive Surgeons (ESCRS).

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