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

Completed · Phase 2 · Has a placebo group

Conditions studied: Presbyopia

In brief

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

Key facts

Study ID

NCT04675151

Run by

Ocuphire Pharma, Inc.

People needed

150

Starts

2021-02-15

Expected to finish

2021-06-30

Last updated by the study team

2025-10-10

Who can join

Age: 40 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Clinical Site 12 — Laguna Hills, California, United States
• Clinical Site 6 — Newport Beach, California, United States
• Clinical Site 13 — Crystal River, Florida, United States
• Clinical Site 5 — Longwood, Florida, United States
• Clinical Site 11 — Maitland, Florida, United States
• Clinical Site 8 — Sarasota, Florida, United States
• Clinical Site 10 — Roswell, Georgia, United States
• Clinical Site 3 — Pittsburg, Kansas, United States
• Clinical Site 18 — St Louis, Missouri, United States
• Clinical Site 16 — Poughkeepsie, New York, United States
• Clinical Site 14 — Fargo, North Dakota, United States
• Clinical Site 2 — Athens, Ohio, United States
• Clinical Site 9 — Cincinnati, Ohio, United States
• Clinical Site 7 — Cleveland, Ohio, United States
• Clinical Site 15 — Powell, Ohio, United States
• Clinical Site 4 — Warwick, Rhode Island, United States
• Clinical Site 1 — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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