Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis
Condition: Mydriasis; Dilation
MeSH terms: Mydriasis; Dilatation, Pathologic
Intervention: Phentolamine Ophthalmic Solution 0.75%; Phentolamine Ophthalmic Solution Vehicle (Placebo)
Intervention description: 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist; Topical sterile ophthalmic solution
Intervention MeSH terms: Phentolamine; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 185.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Nyxol; Pharmacologically Induced Mydriasis; Dilation

Summary:

      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
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or females ≥ 12 years of age

          2. Otherwise healthy and well controlled subjects

        Exclusion Criteria:

        Ophthalmic (in either eye):

          1. Clinically significant ocular disease as deemed by the Investigator 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, ocular surgery or non-refractive laser treatment 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

          7. History of diabetic retinopathy or diabetic macular edema

          8. Closed or very narrow angles that in the Investigator's opinion are potentially
             occludable if the subject's pupil is dilated

          9. History of any traumatic (surgical or nonsurgical) or non-traumatic condition
             affecting the pupil or iris

         10. Known allergy or contraindication to any component of the mydriatic agents or the
             vehicle formulation

         11. History of cauterization of the punctum or punctal plug (silicone or collagen)
             insertion or removal

        Systemic:

          1. Known hypersensitivity or contraindication to α- and/or β adrenoceptor antagonists.

          2. Clinically significant systemic disease that might interfere with the study

          3. 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

          4. Participation in any investigational study within 30 days prior to screening

          5. Females of childbearing potential who are pregnant, nursing, planning a pregnancy, or
             not using a medically acceptable form of birth control

          6. Resting HR outside the normal range (50-110 beats per minute)

          7. Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHg