Safety and Efficacy of Nyxol Eye Drops as a Single Agent and With Adjunctive Low-Dose Pilocarpine Eye Drops in Subjects With Presbyopia
NCT ID: NCT05646719
Last Updated: 2025-10-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
333 participants
INTERVENTIONAL
2022-12-22
2023-10-11
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Nyxol + low dose pilocarpine
Nyxol (phentolamine ophthalmic solution) 0.75% Pilocarpine (0.4%)
Phentolamine Opthalmic Solution 0.75%
phentolamine ophthalmic solution 0.75% (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
Low dose pilocarpine
Pilocarpine hydrochloride ophthalmic solution 0.4%
Nyxol + low dose pilocarpine vehicle
Nyxol (phentolamine ophthalmic solution) 0.75% Pilocarpine vehicle
Phentolamine Opthalmic Solution 0.75%
phentolamine ophthalmic solution 0.75% (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
Low dose pilocarpine vehicle
Vehicle for low dose pilocarpine
Placebo + low dose pilocarpine
Placebo Pilocarpine (0.4%)
Placebo
Vehicle for Phentolamine Ophthalmic Solution
Low dose pilocarpine
Pilocarpine hydrochloride ophthalmic solution 0.4%
Placebo + low dose pilocarpine vehicle
Placebo Pilocarpine vehicle
Placebo
Vehicle for Phentolamine Ophthalmic Solution
Low dose pilocarpine vehicle
Vehicle for low dose pilocarpine
Nyxol
Nyxol (phentolamine ophthalmic solution) 0.75%
Phentolamine Opthalmic Solution 0.75%
phentolamine ophthalmic solution 0.75% (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
Nyxol placebo
Nyxol placebo
Placebo
Vehicle for Phentolamine Ophthalmic Solution
Interventions
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Phentolamine Opthalmic Solution 0.75%
phentolamine ophthalmic solution 0.75% (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
Placebo
Vehicle for Phentolamine Ophthalmic Solution
Low dose pilocarpine
Pilocarpine hydrochloride ophthalmic solution 0.4%
Low dose pilocarpine vehicle
Vehicle for low dose pilocarpine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. BCDVA of 0.1 LogMAR (20/25 Snellen equivalent) or better in each eye in photopic conditions.
3. 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.
4. For subjects who depend on reading glasses or bifocals, binocular best-corrected near VA is 0.1 LogMAR (20/25 Snellen equivalent) or better.
5. Photopic PD of ≥ 3 mm in either eye.
Exclusion Criteria
1. 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.
2. Use of any OTC artificial tears (preserved or unpreserved) during Visit days or 15 min before or after instillation of study medication.
3. Current use of any topical ophthalmic therapy for dry eye.
4. 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..
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. Known allergy, hypersensitivity, or contraindication to any component of the phentolamine, pilocarpine, or vehicle formulations.
9. Prior participation in a study involving the use of Nyxol for the treatment of presbyopia.
10. History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal.
11. Ocular trauma within 6 months prior to Screening.
12. Ocular surgery or any ocular laser treatment within 6 months prior to Screening.
13. Subjects with surgical monovision, multifocal or extended depth of focus intraocular lenses (IOLs) are excluded.
14. History of any traumatic (surgical or nonsurgical) or nontraumatic condition affecting the pupil or iris.
15. 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:
16. Known hypersensitivity or contraindication to alpha- and/or beta-adrenoceptor antagonists .
17. Known hypersensitivity or contraindication to any systemic cholinergic parasympathomimetic agent.
18. Clinically significant systemic disease that might interfere with the study as deemed by the judgment of the Investigator.
19. 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.
20. Participation in any investigational study within 30 days prior to Screening.
21. Females of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.
22. Resting HR outside the range of 50 to 110 beats per min.
23. Hypertension with resting diastolic BP \> 105 mmHg or systolic BP \> 160 mmHg.
40 Years
64 Years
ALL
No
Sponsors
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Ocuphire Pharma, Inc.
INDUSTRY
Responsible Party
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Locations
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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
San Antonio, TX
San Antonio, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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OPI-NYXP-301 (VEGA-2)
Identifier Type: -
Identifier Source: org_study_id
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