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

Inclusion criteria

• Males or females ≥ 40 and ≤ 64years of age.
• BCDVA of 0.0 LogMAR(20/20 Snellen equivalent) or better in each eye under photopic conditions.
• DCNVA of 0.4 LogMAR (20/50 Snellen equivalent) or worse under photopic conditions in each eye and binocularly.
• 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):

• Use of any topical prescription or OTC ophthalmic medications of any kind within 7 days of Screening until study completion.
• 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.
• Current use of any topical ophthalmic therapy for dry eye.
• Tear break-up time of < 5 seconds or corneal fluorescein staining.
• Clinically significant ocular disease that might interfere with the study as deemed by the Investigator.
• Recent or current evidence of ocular infection or inflammation in either eye.
• Any history of herpes simplex or herpes zoster keratitis.
• History of diabetic retinopathy or diabetic macular edema.
• Known allergy, hypersensitivity, or contraindication to any component of the phentolamine, pilocarpine, or vehicle formulations.
• History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal.
• Ocular trauma, ocular surgery, ocular laser treatment within the 6 months prior to Screening. Any subject with multifocal intraocular lenses are excluded.
• History of any traumatic (surgical or nonsurgical) or non traumatic condition affecting the pupil or iris.
• Unwilling or unable to discontinue use of contact lenses.
• Conjunctival hyperemia ≥ grade 2 on the CCLRU 4-point scale.

Systemic:

• Known hypersensitivity or contraindication to alpha- and/or beta adrenoceptor antagonists.
• Known hypersensitivity or contraindication to any systemic cholinergic parasympathomimetic agents.
• Clinically significant systemic disease that might interfere with the study as deemed by the Investigator.
• Participation in any investigational study within 30 days prior to Screening.
• Females of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.
• Resting HR outside the specified range of 50 to 110 beats per minute.
• Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHg.