Safety and Efficacy of Nyxol Eye Drops as a Single Agent and With Adjunctive Low-Dose Pilocarpine Eye Drops in Subjects With Presbyopia

This is a Randomized, Double-Masked, Placebo-Controlled, Multicenter, Phase 3 Study of the Safety and Efficacy of Nyxol (Phentolamine Ophthalmic Solution 0.75%) as a Single Agent and With Adjunctive Low-Dose Pilocarpine Hydrochloride Ophthalmic Solution 0.4% in Subjects With Presbyopia

Inclusion criteria

• Males or females ≥ 40 and ≤ 64 years of age.
• BCDVA of 0.1 LogMAR (20/25 Snellen equivalent) or better in each eye in photopic conditions.
• DCNVA of 0.4 LogMAR (20/50 Snellen equivalent) or worse but not > 0.7 LogMAR (20/100 Snellen equivalent) in photopic conditions in each eye and binocularly.
• For subjects who depend on reading glasses or bifocals, binocular best-corrected near VA is 0.1 LogMAR (20/25 Snellen equivalent) or better.
• Photopic PD of ≥ 3 mm in either eye.

Exclusion criteria

Ophthalmic (in either eye):

• Use of any topical prescription or over-the-counter (OTC) ophthalmic medications of any kind within 7 days of Screening until study completion, with the exception of lid scrubs with OTC products and artificial tears as specified in Exclusion # 2 below.
• Use of any OTC artificial tears (preserved or unpreserved) during Visit days or 15 min before or after instillation of study medication.
• Current use of any topical ophthalmic therapy for dry eye.
• Tear break-up time of < 5 seconds or corneal fluorescein staining Grade ≥ 2 in the inferior zone or Grade ≥ 1 in the central zone using the National Eye Institute scale..
• 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.
• Known allergy, hypersensitivity, or contraindication to any component of the phentolamine, pilocarpine, or vehicle formulations.
• Prior participation in a study involving the use of Nyxol for the treatment of presbyopia.
• History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal.
• Ocular trauma within 6 months prior to Screening.
• Ocular surgery or any ocular laser treatment within 6 months prior to Screening.
• Subjects with surgical monovision, multifocal or extended depth of focus intraocular lenses (IOLs) are excluded.
• History of any traumatic (surgical or nonsurgical) or nontraumatic condition affecting the pupil or iris.
• Contact lens wear on the day of any study visit and contact lenses must be removed for home dosing and for at least 10 minutes following dosing.

Systemic:

• Known hypersensitivity or contraindication to alpha- and/or beta-adrenoceptor antagonists .
• Known hypersensitivity or contraindication to any systemic cholinergic parasympathomimetic agent.
• Clinically significant systemic disease that might interfere with the study as deemed by the judgment of the Investigator.
• Initiation of treatment with, or any changes to, the current dosage, drug, or regimen of any systemic adrenergic or cholinergic drugs within 7 days prior to Screening or during the study.
• 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 range of 50 to 110 beats per min.
• Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHg.