Safety and Efficacy of Nyxol With Pilocarpine Eye Drops in Subjects With Presbyopia
Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) With Pilocarpine Eye Drops in Subjects With Presbyopia
1 other identifier
interventional
150
1 country
17
Brief Summary
The objectives of this study are: To evaluate the efficacy of Nyxol + Pilocarpine to improve DCNVA in subjects with presbyopia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2021
Shorter than P25 for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2020
CompletedFirst Posted
Study publicly available on registry
December 19, 2020
CompletedStudy Start
First participant enrolled
February 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 17, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedResults Posted
Study results publicly available
August 2, 2023
CompletedOctober 10, 2025
June 1, 2023
3 months
December 15, 2020
June 23, 2023
September 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent of Subjects With ≥ 15 Letters of Improvement in Photopic Binocular DCNVA
The primary efficacy endpoint was the percent of subjects with ≥ 15 letters of improvement in photopic binocular DCNVA on Visit 2 at 1 hour with POS + LDP compared to placebo alone. The improvement in binocular DCNVA for each subject was relative to the subject's own baseline value (Visit 1).
Visit 2 at 1 hour
Secondary Outcomes (3)
Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline
Visit 2 at 0.5 hours, at 2 hours, at 3 hours, at 4 hours, and at 6 hours
Percentage of Subjects With Improvement of ≥ 15 Letters in DCNVA (Photopic) at 1 Hour and With < 5 Letters of Loss in Photopic Binocular BCDVA From Baseline
Visit 2 at 1 hour
Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline
Visit 2 at 1 hour, at 3 hours, and at 6 hours
Study Arms (4)
Nyxol + Pilocarpine
EXPERIMENTAL1 drop of Nyxol (Treatment 1) and 1 drop of Pilocarpine (Treatment 2)
Nyxol
ACTIVE COMPARATOR1 drop of Nyxol (Treatment 1)
Pilocarpine
ACTIVE COMPARATOR1 drop of Pilocarpine (Treatment 2)
Placebo
PLACEBO COMPARATOR1 drop of Placebo (Treatment 1)
Interventions
0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
Topical sterile ophthalmic solution
Eligibility Criteria
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.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Clinical Site 12
Laguna Hills, California, 92653, United States
Clinical Site 6
Newport Beach, California, 92663, United States
Clinical Site 13
Crystal River, Florida, 34461, United States
Clinical Site 5
Longwood, Florida, 32779, United States
Clinical Site 11
Maitland, Florida, 32751, United States
Clinical Site 8
Sarasota, Florida, 34239, United States
Clinical Site 10
Roswell, Georgia, 30041, United States
Clinical Site 3
Pittsburg, Kansas, 66762, United States
Clinical Site 18
St Louis, Missouri, 63101, United States
Clinical Site 16
Poughkeepsie, New York, 12603, United States
Clinical Site 14
Fargo, North Dakota, 58103, United States
Clinical Site 2
Athens, Ohio, 45701, United States
Clinical Site 9
Cincinnati, Ohio, 45242, United States
Clinical Site 7
Cleveland, Ohio, 44115, United States
Clinical Site 15
Powell, Ohio, 43065, United States
Clinical Site 4
Warwick, Rhode Island, 02888, United States
Clinical Site 1
Memphis, Tennessee, 38119, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Drey Coleman
- Organization
- Ocuphire Pharma, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2020
First Posted
December 19, 2020
Study Start
February 15, 2021
Primary Completion
May 17, 2021
Study Completion
June 30, 2021
Last Updated
October 10, 2025
Results First Posted
August 2, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share