Safety and Efficacy of Ophthalmic Phentolamine Mesylate to Reverse Pharmacologically Induced Mydriasis
Condition: Mydriasis; Dilation
MeSH terms: Mydriasis; Dilatation, Pathologic
Intervention: Phentolamine Mesylate Ophthalmic Solution 1%; Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)
Intervention description: 1% phentolamine mesylate 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 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 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 (phentolamine mesylate ophthalmic solution 1%) to
           expedite the reversal of pharmacologic mydriasis

        -  To evaluate the safety of Nyxol

        -  To evaluate the effect of Lumify® to suppress conjunctival hyperemia (redness)
           potentially associated with administration of Nyxol
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or females ≥ 18 and ≤ 45 years of age with brown irides (irises) only

          2. Otherwise healthy and well controlled subjects

          3. Able to comply with all protocol mandated procedures and to attend all scheduled
             office visits

          4. Willing to give written informed consent to participate in this study

        Exclusion Criteria

          1. Clinically significant ocular disease as deemed by the Investigator (e.g., cataract,
             glaucoma, corneal edema, uveitis, severe keratoconjunctivitis sicca) that might
             interfere with the study

          2. Unwilling or unable to discontinue use of contact lenses during treatment visits

          3. Ocular trauma, ocular surgery or non-refractive laser treatment within the 6 months
             prior to screening

          4. Ocular medication of any kind within 30 days of screening, with the exception of a)
             lid scrubs (which may have been used prior to, but not after screening) or b)
             lubricating drops for dry eye (preservative-free artificial tears), which may be used
             in between the study treatment days

          5. Recent or current evidence of ocular infection or inflammation. Current evidence of
             clinically significant blepharitis, conjunctivitis, or a history of herpes simplex or
             herpes zoster keratitis at screening

          6. History of diabetic retinopathy

          7. Closed or very narrow angles that in the Investigator's opinion are 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 (e.g., irregularly shaped pupil, neurogenic pupil
             disorder, iris atrophy, iridotomy)

          9. Known allergy or contraindication to any component of the mydriatic agents or the
             vehicle formulation

         10. Known hypersensitivity or contraindication to α- and/or β-adrenoceptor antagonists
             (e.g., chronic obstructive pulmonary disease or bronchial asthma; abnormally low blood
             pressure (BP) or heart rate (HR); second- or third-degree heart blockage or Congestive
             Heart Failure (CHF); severe diabetes)

         11. Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia
             gravis, cancer, hepatic, renal, endocrine or cardiovascular disorders) that might
             interfere with the study

         12. Initiation of treatment with or any changes to the current dosage, drug or regimen of
             any topical or systemic adrenergic or cholinergic drugs up to 7 days prior to
             screening, or during the study

         13. Participation in any investigational study within 30 days prior to screening

         14. Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or
             not using a medically acceptable form of birth control. Acceptable methods include the
             use of at least one of the following: intrauterine device (IUD), hormonal (oral,
             injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or
             abstinence. An adult woman is considered to be of childbearing potential unless she is
             1 year postmenopausal or 3 months post-surgical sterilization. All females of
             childbearing potential must have a negative urine pregnancy test result at Visit
             1/Screening and Visit 2 examinations and must intend to not become pregnant during the
             study

         15. Resting heart rate (HR) outside the normal range (50-110 beats per minute) at the
             Screening Visit. HR may be repeated only once if outside the normal range following at
             least a 5-minute rest period in the sitting position

         16. Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHg at the
             Screening Visit. BP may be repeated only once if outside the specified range following
             at least a 5-minute rest period in the sitting position