Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis (MIRA-3)
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: 368.0
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

        -  To evaluate the systemic exposure of Nyxol on pharmacokinetic (PK) sampling
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or females ≥ 12 years of age

          2. Ability to comply with all protocol-mandated procedures independently and to attend
             all scheduled office visits

        Exclusion Criteria:

          1. Clinically significant ocular disease as deemed by the Investigator (eg, glaucoma,
             corneal edema, uveitis, severe keratoconjunctivitis sicca) 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, with the exception of lid scrubs with OTC
             products (eg, OCuSOFT® lid scrub, SteriLid®, baby shampoo, etc.)

          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. Prior participation in a study involving the use of Nyxol for the reversal of
             mydriasis

          9. Known hypersensitivity or contraindication to α- and/or β-adrenoceptor antagonists

         10. Clinically significant systemic disease (eg, uncontrolled diabetes, myasthenia gravis,
             cancer, hepatic, renal, endocrine, or cardiovascular disorders) that might interfere
             with the study

         11. Participation in any investigational study within 30 days prior to screening

         12. Resting heart rate (HR) outside the normal range (50-110 beats per minute) at the
             Screening Visit.

         13. Hypertension with resting diastolic blood pressure (BP)>105 mmHg or systolic BP > 160
             mmHg at the Screening Visit.