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

Completed · Phase 3 · Has a placebo group

Conditions studied: Presbyopia

In brief

The objectives of this study are: To evaluate the safety and efficacy of Nyxol alone and with adjunctive low dose pilocarpine to improve distance-corrected near visual acuity (DCNVA) in subjects with presbyopia.

Key facts

Study ID

NCT05646719

Run by

Ocuphire Pharma, Inc.

People needed

333

Starts

2022-12-22

Expected to finish

2023-10-11

Last updated by the study team

2026-07-13

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 ≤ 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.

You may not qualify if…

• 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.

Where it is running

• Phoenix, AZ — Phoenix, Arizona, United States
• Azusa, CA — Azusa, California, United States
• Newport Beach, CA — Newport Beach, California, United States
• Northridge, CA — Northridge, California, United States
• Delray Beach, FL — Delray Beach, Florida, United States
• Longwood, FL — Longwood, Florida, United States
• Roswell, GA — Roswell, Georgia, United States
• Lake Villa, IL — Lake Villa, Illinois, United States
• Pittsburg, KS — Pittsburg, Kansas, United States
• Shawnee Mission, KS — Shawnee Mission, Kansas, United States
• Bloomington, MN — Bloomington, Minnesota, United States
• Chesterfield, MO — Chesterfield, Missouri, United States
• Kansas City, MO — Kansas City, Missouri, United States
• Saint Louis, MO — St Louis, Missouri, United States
• Rochester, NY — Rochester, New York, United States
• Smithtown, NY — Smithtown, New York, United States
• Garner, NC — Garner, North Carolina, United States
• Fargo, ND — Fargo, North Dakota, United States
• Athens, OH — Athens, Ohio, United States
• Cranberry Township, PA — Cranberry Township, Pennsylvania, United States
• New Freedom, PA — New Freedom, Pennsylvania, United States
• Sioux Falls, SD — Sioux Falls, South Dakota, United States
• Memphis, TN — Memphis, Tennessee, United States
• Austin, TX — Austin, Texas, United States
• Houston, TX — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.