Safety and Efficacy of Nyxol With Pilocarpine Eye Drops in Subjects With Presbyopia
Condition: Presbyopia
MeSH terms: Presbyopia
Intervention: Phentolamine Ophthalmic Solution 0.75%; Pilocarpine; Placebo
Intervention description: 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist; Pilocarpine ophthalmic solution; Topical sterile ophthalmic solution
Intervention MeSH terms: Phentolamine; Pharmaceutical Solutions; Ophthalmic Solutions; Pilocarpine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 150.0
Sex: All
Minimum age: 40 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Nyxol; Presbyopia; Pilocarpine

Summary:

      The objectives of this study are:

      To evaluate the efficacy of Nyxol + Pilocarpine to improve DCNVA in subjects with presbyopia
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or females ≥ 40 and ≤ 64years of age.

          2. BCDVA of 0.0 LogMAR(20/20 Snellen equivalent) or better in each eye under photopic
             conditions.

          3. DCNVA of 0.4 LogMAR (20/50 Snellen equivalent) or worse under photopic conditions in
             each eye and binocularly.

          4. Subjects who depend on reading glasses or bifocals in which their binocular
             best-corrected near VA is 0.1 LogMAR (20/25 Snellen equivalent) or better.

        Exclusion Criteria:

        Ophthalmic (in either eye):

          1. Use of any topical prescription or OTC ophthalmic medications of any kind within 7
             days of Screening until study completion.

          2. Use of any over-the-counter (OTC) artificial tears (preserved or unpreserved) at least
             once per day within 7 days of Screening until study completion.

          3. Current use of any topical ophthalmic therapy for dry eye.

          4. Tear break-up time of < 5 seconds or corneal fluorescein staining.

          5. Clinically significant ocular disease that might interfere with the study as deemed by
             the Investigator.

          6. Recent or current evidence of ocular infection or inflammation in either eye.

          7. Any history of herpes simplex or herpes zoster keratitis.

          8. History of diabetic retinopathy or diabetic macular edema.

          9. Known allergy, hypersensitivity, or contraindication to any component of the
             phentolamine, pilocarpine, or vehicle formulations.

         10. History of cauterization of the punctum or punctal plug (silicone or collagen)
             insertion or removal.

         11. Ocular trauma, ocular surgery, ocular laser treatment within the 6 months prior to
             Screening. Any subject with multifocal intraocular lenses are excluded.

         12. History of any traumatic (surgical or nonsurgical) or non traumatic condition
             affecting the pupil or iris.

         13. Unwilling or unable to discontinue use of contact lenses.

         14. Conjunctival hyperemia ≥ grade 2 on the CCLRU 4-point scale.

             Systemic:

         15. Known hypersensitivity or contraindication to alpha- and/or beta adrenoceptor
             antagonists.

         16. Known hypersensitivity or contraindication to any systemic cholinergic
             parasympathomimetic agents.

         17. Clinically significant systemic disease that might interfere with the study as deemed
             by the Investigator.

         18. Participation in any investigational study within 30 days prior to Screening.

         19. Females of childbearing potential who are pregnant, nursing, planning a pregnancy, or
             not using a medically acceptable form of birth control.

         20. Resting HR outside the specified range of 50 to 110 beats per minute.

         21. Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHg.