Clinical trial
Randomized, Double-Masked, Placebo-Controlled, Multicenter, Phase 3 Study of the Safety and Efficacy of Nyxol (Phentolamine Ophthalmic Solution 0.75%) as a Single Agent and With Adjunctive Low-Dose Pilocarpine Hydrochloride Ophthalmic Solution 0.4% in Subjects With Presbyopia
Name
OPI-NYXP-301 (VEGA-2)
Description
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.
Trial arms
Trial start
2022-12-22
Estimated PCD
2023-10-11
Trial end
2023-10-11
Status
Completed
Phase
Early phase I
Treatment
Phentolamine Opthalmic Solution 0.75%
phentolamine ophthalmic solution 0.75% (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
Arms:
Nyxol + low dose pilocarpine, Nyxol + low dose pilocarpine vehicle
Other names:
Nyxol
Placebo
Vehicle for Phentolamine Ophthalmic Solution
Arms:
Placebo + low dose pilocarpine, Placebo + low dose pilocarpine vehicle
Other names:
Phentolamine Ophthalmic Solution Vehicle
Low dose pilocarpine
Pilocarpine hydrochloride ophthalmic solution 0.4%
Arms:
Nyxol + low dose pilocarpine, Placebo + low dose pilocarpine
Other names:
Pilocarpine, LDP
Low dose pilocarpine vehicle
Vehicle for low dose pilocarpine
Arms:
Nyxol + low dose pilocarpine vehicle, Placebo + low dose pilocarpine vehicle
Size
333
Primary endpoint
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
Baseline at 30 min post-LDP/vehicle comparing subjects treated with Nyxol + LDP to subjects treated with placebo + LDP vehicle at Visit 5 (Stage 2 Day 8)
Eligibility criteria
Inclusion Criteria:
1. Males or females ≥ 40 and ≤ 64 years of age.
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:
Ophthalmic (in either eye):
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 333, 'type': 'ACTUAL'}}
Updated at
2023-11-24
1 organization
2 products
1 indication
Organization
Ocuphire PharmaProduct
PhentolamineIndication
PresbyopiaProduct
Pilocarpine