Phase 2
N=150
Safety and Efficacy of Nyxol With Pilocarpine Eye Drops in Subjects With Presbyopia
Presbyopia
Bottom Line
View on ClinicalTrials.gov: NCT04675151 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Percent of Subjects With ≥ 15 Letters of Improvement in Photopic Binocular DCNVA — 60.5; 30.0; 45.2; 27.3 percentage of subjects with ≥ 15 letters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Phentolamine Ophthalmic Solution 0.75% (Drug); Pilocarpine (Drug); Placebo (Other)
- Age
- Adult · 40+ yrs
- Sex
- All
- Sponsor
- Ocuphire Pharma, Inc.
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Subjects With ≥ 15 Letters of Improvement in Photopic Binocular DCNVA |
60.5; 30.0; 45.2; 27.3 | — |
| SECONDARY Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline |
88.4; 86.7; 74.2; 70.5; 76.7; 50.0 | — |
| SECONDARY 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 |
60.5; 30.0; 41.9; 27.93 | — |
| SECONDARY Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline |
86.0; 46.7; 71.0; 56.8; 48.8; 23.3 | — |
Summary
The objectives of this study are:
To evaluate the efficacy of Nyxol + Pilocarpine to improve DCNVA in subjects with presbyopia
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
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 105 mmHg or systolic BP > 160 mmHg.
Data sourced from ClinicalTrials.gov (NCT04675151). 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.