MIRA-4: Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis in Pediatric Subjects

About the Trial

Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis in Pediatric Subjects (NCT05223478).

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 Pediatric Subjects.

Detailed Info

The objectives of this study are:* To evaluate the safety of Nyxol in pediatric subjects * To evaluate the efficacy of Nyxol to expedite the reversal of pharmacologically induced mydriasis in pediatric subjects The Sponsor intends to use this study to evaluate Nyxol in pediatric subjects aged 3 to 11 for the indication "the treatment of pharmacologically induced mydriasis produced by adrenergic (phenylephrine) or parasympatholytic (tropicamide) agents, or a combination thereof."

Study Phase

Phase 3

Estimated Enrollment

23

Estimated Primary Completion Date

April 18, 2022

Study Type

Interventional

Interventions
  • Drug: Phentolamine Ophthalmic Solution 0.75%
  • Drug: Phentolamine Ophthalmic Solution Vehicle
Sponsor

Ocuphire Pharma, Inc.

Eligibility

Inclusion Criteria

  • Males or premenstrual females 3 to 11 years of age
  • Ability to comply with all protocol-mandated procedures independently and to attend all scheduled office visits
  • Parent/Legal guardian willing to give written informed consent to participate in this study. Children aged 7 to 11 years to provide signed assent form, as well as a separate parental/legal guardian consent.

Exclusion Criteria

  • Clinically significant ocular disease as deemed by the Investigator(eg, amblyopia, congenital cataract, congenital glaucoma) 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 or ocular surgery 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 (such as current evidence of clinically significant blepharitis, conjunctivitis, or keratitis). Subjects must be symptom-free for at least 7 days prior to screening
  • Closed or very narrow-angle that in the Investigator's opinion is 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, hypersensitivity, or contraindication to any component of the phentolamine ophthalmic solution or to any component of the mydriatic agents or vehicle formulation

Systemic:

  • Known hypersensitivity or contraindication to α- and/or β-adrenoceptor antagonists
  • Clinically significant systemic disease (eg, uncontrolled diabetes, cancer, hepatic, renal, endocrine, or cardiovascular disorders) that in the opinion of the Investigator could interfere with the study
  • Subjects with learning disabilities that in the opinion of the investigator could 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(Appendix 4)
  • Participation in any investigational study within 30 days prior to screening

Locations