Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis in Pediatric Subjects
Condition: Mydriasis; Dilation
MeSH terms: Mydriasis; Dilatation, Pathologic
Intervention: Phentolamine Ophthalmic Solution 0.75%; Phentolamine Ophthalmic Solution Vehicle
Intervention description: 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist; Phentolamine Ophthalmic Solution Vehicle
Intervention MeSH terms: Phentolamine; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 23.0
Sex: All
Minimum age: 3 Years
Maximum age: 11 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Nyxol; Pharmacologically Induced Mydriasis; Dilation; Pediatrics; Phentolamine; Mydriasis; Phenylephrine; Tropicamide; Paremyd

Summary:

      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."
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or premenstrual females 3 to 11 years of age

          2. Ability to comply with all protocol-mandated procedures independently and to attend
             all scheduled office visits

          3. 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:

          1. Clinically significant ocular disease as deemed by the Investigator(eg, amblyopia,
             congenital cataract, congenital glaucoma) that might interfere with the study

          2. Unwilling or unable to discontinue use of contact lenses at screening until study
             completion

          3. Unwilling or unable to suspend use of topical medication at screening until study
             completion

          4. Ocular trauma or ocular surgery within the 6 months prior to screening

          5. Use of any topical prescription or over-the-counter (OTC)ophthalmic medications of any
             kind within 7 days of screening

          6. 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

          7. Closed or very narrow-angle that in the Investigator's opinion is potentially
             occludable if the subject's pupil is dilated

          8. History of any traumatic (surgical or nonsurgical) or non-traumatic condition
             affecting the pupil or iris

          9. 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:

         10. Known hypersensitivity or contraindication to α- and/or β-adrenoceptor antagonists

         11. 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

         12. Subjects with learning disabilities that in the opinion of the investigator could
             interfere with the study

         13. 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)

         14. Participation in any investigational study within 30 days prior to screening