MIRA-2: Reversal of Mydriasis Phase 3 Clinical Trial for Nyxol

About the Trial

Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis (NCT04620213)

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

Detailed Info

The objectives of this study are:

- To evaluate the efficacy of Nyxol to expedite the reversal of pharmacologically-induced
mydriasis across multiple mydriatic agents with an emphasis on phenylephrine

- To evaluate the efficacy of Nyxol to return subjects to baseline accommodation after
worsening (with cycloplegic agents tropicamide and Paremyd)

- To evaluate the safety of Nyxol

- To evaluate any additional benefits of the reversal of pharmacologically-induced
mydriasis

Study Phase

Phase 3

Estimated Enrollment

168

Estimated Primary Completion Date

March 1, 2021

Study Type

Interventional

Interventions
  • Drug: Phentolamine Ophthalmic Solution 0.75%
  • Other: Phentolamine Ophthalmic Solution Vehicle (Placebo)
Sponsor

Ocuphire Pharma, Inc.

Eligibility

Inclusion Criteria

  • Males or females ≥ 12 years of age
  • Otherwise healthy and well controlled subjects

Exclusion Criteria

Ophthalmic (in either eye):

  • Clinically significant ocular disease as deemed by the Investigator that might interfere with the study
  • Unwilling or unable to discontinue use of contact lenses at screening until study completion
  • Unwilling or unable to suspend use of topical medication at screening until study completion
  • Ocular trauma, ocular surgery or non-refractive laser treatment within the 6 months prior to screening
  • Use of any topical prescription or over-the-counter (OTC) ophthalmic medications of any kind within 7 days of screening
  • Recent or current evidence of ocular infection or inflammation in either eye
  • History of diabetic retinopathy or diabetic macular edema
  • Closed or very narrow angles that in the Investigator's opinion are potentially occludable if the subject's pupil is dilated
  • History of any traumatic (surgical or nonsurgical) or non-traumatic condition affecting the pupil or iris
  • Known allergy or contraindication to any component of the mydriatic agents or the vehicle formulation
  • History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal

Systemic:

  • Known hypersensitivity or contraindication to α- and/or β adrenoceptor antagonists.
  • Clinically significant systemic disease that might interfere with the study
  • Initiation of treatment with or any changes to the current dosage, drug or regimen of any systemic adrenergic or cholinergic drugs within 7 days prior to screening, or during the study
  • Participation in any investigational study within 30 days prior to screening
  • Females of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control
  • Resting HR outside the normal range (50-110 beats per minute)
  • Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHg

Locations

The following cities have clinical trial sites that are either recruiting or will be soon.

Enrollment

For more information on enrollment in our current clinical trials, please contact us or visit clinicaltrials.gov for location information.

Contact a Trial Coordinator for more information on our trials.

The safety and efficacy of the investigational use of these products have not been determined. There is no guarantee that the investigational use listed will be filed with and/or approved for marketing by a regulatory agency.

Frequently Asked Questions

A Clinical Trial is a type of research study that examines how well a potential therapy works in humans.

The objectives of this study are:

  • To evaluate the efficacy of Nyxol to expedite the reversal of pharmacologically-induced mydriasis across multiple mydriatic agents with an emphasis on phenylephrine
  • To evaluate the efficacy of Nyxol to return subjects to baseline accommodation after worsening (with cycloplegic agents tropicamide and Paremyd)
  • To evaluate the safety of Nyxol
  • To evaluate any additional benefits of the reversal of pharmacologically-induced mydriasis

This clinical trial has certain criteria that a person has to meet to determine if they can participate. Please discuss the trial with your doctor, and then please visit clinicaltrial.gov to find further contact information.

Ocuphire Pharma is sponsoring this clinical trial.

There will be a total of 168 patients enrolled in this clinical trial.