Safety and Efficacy of Nyxol With Pilocarpine Eye Drops in Subjects With Presbyopia

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.