Phase 3
N=333
Safety and Efficacy of Nyxol Eye Drops as a Single Agent and With Adjunctive Low-Dose Pilocarpine Eye Drops in Subjects With Presbyopia
Presbyopia
Bottom Line
View on ClinicalTrials.gov: NCT05646719 ↗Enrolled (actual)
333
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Percent of Subjects With ≥ 15 Letters of Improvement in Photopic Binocular DCNVA and With < 5 Letters of Loss in Photopic Binocular BCDVA in Nyxol-treated Subjects — 27; 31; 16; 22 Participants — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Phentolamine Opthalmic Solution 0.75% (Drug); Placebo (Other); Low dose pilocarpine (Drug); Low dose pilocarpine vehicle (Other)
- Age
- Adult · 40+ yrs
- Sex
- All
- Sponsor
- Ocuphire Pharma, Inc.
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Subjects With ≥ 15 Letters of Improvement in Photopic Binocular DCNVA and With < 5 Letters of Loss in Photopic Binocular BCDVA in Nyxol-treated Subjects |
27; 31; 16; 22 | <0.01 sig |
Summary
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.
Eligibility Criteria
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 105 mmHg or systolic BP > 160 mmHg.
Data sourced from ClinicalTrials.gov (NCT05646719). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.