Status:
COMPLETED
Safety and Efficacy of Nyxol With Pilocarpine Eye Drops in Subjects With Presbyopia
Lead Sponsor:
Ocuphire Pharma, Inc.
Conditions:
Presbyopia
Eligibility:
All Genders
40-64 years
Phase:
PHASE2
Brief Summary
The objectives of this study are: To evaluate the efficacy of Nyxol + Pilocarpine to improve DCNVA in subjects with presbyopia
Eligibility Criteria
Inclusion
- 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
- 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.
- Systemic:
- Known hypersensitivity or contraindication to alpha- and/or beta adrenoceptor antagonists.
- Known hypersensitivity or contraindication to any systemic cholinergic parasympathomimetic agents.
- Clinically significant systemic disease that might interfere with the study as deemed by the Investigator.
- 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 specified range of 50 to 110 beats per minute.
- Hypertension with resting diastolic BP \> 105 mmHg or systolic BP \> 160 mmHg.
Key Trial Info
Start Date :
February 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04675151
Start Date
February 15 2021
End Date
June 30 2021
Last Update
October 10 2025
Active Locations (17)
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1
Clinical Site 12
Laguna Hills, California, United States, 92653
2
Clinical Site 6
Newport Beach, California, United States, 92663
3
Clinical Site 13
Crystal River, Florida, United States, 34461
4
Clinical Site 5
Longwood, Florida, United States, 32779