Safety and Efficacy of Nyxol With Pilocarpine Eye Drops in Subjects With Presbyopia
Study Details
Study Description
Brief Summary
The objectives of this study are:
To evaluate the efficacy of Nyxol + Pilocarpine to improve DCNVA in subjects with presbyopia
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Nyxol + Pilocarpine 1 drop of Nyxol (Treatment 1) and 1 drop of Pilocarpine (Treatment 2) |
Drug: Phentolamine Ophthalmic Solution 0.75%
0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
Other Names:
Drug: Pilocarpine
Pilocarpine ophthalmic solution
|
Active Comparator: Nyxol 1 drop of Nyxol (Treatment 1) |
Drug: Phentolamine Ophthalmic Solution 0.75%
0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
Other Names:
|
Active Comparator: Pilocarpine 1 drop of Pilocarpine (Treatment 2) |
Drug: Pilocarpine
Pilocarpine ophthalmic solution
Other: Placebo
Topical sterile ophthalmic solution
Other Names:
|
Placebo Comparator: Placebo 1 drop of Placebo (Treatment 1) |
Other: Placebo
Topical sterile ophthalmic solution
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percent of subjects with ≥ 15 letters of improvement in photopic binocular DCNVA [up to 6 hours]
The percent of subjects with ≥ 15 letters of improvement in photopic binocular DCNVA
Secondary Outcome Measures
- Percentage of subjects with improvement of ≥ 5, ≥ 10, and ≥ 15 letters in DCNVA (photopic) from Baseline [up to 6 hours]
The percentage of subjects with improvement of ≥ 5, ≥ 10, and ≥ 15 letters in DCNVA (photopic) from Baseline
- 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 [up to 6 hours]
The 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
- Percentage of subjects with improvement in BCIVA (photopic) from Baseline [up to 6 hours]
The percentage of subjects with improvement in BCIVA (photopic) from Baseline of ≥ 5, ≥ 10, and ≥ 15 letters
Eligibility Criteria
Criteria
Inclusion Criteria:
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Males or females ≥ 40 and ≤ 64years of age.
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BCDVA of 0.0 LogMAR(20/20 Snellen equivalent) or better in each eye under photopic conditions.
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DCNVA of 0.4 LogMAR (20/50 Snellen equivalent) or worse under photopic conditions in each eye and binocularly.
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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):
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Use of any topical prescription or OTC ophthalmic medications of any kind within 7 days of Screening until study completion.
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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.
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Current use of any topical ophthalmic therapy for dry eye.
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Tear break-up time of < 5 seconds or corneal fluorescein staining.
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Clinically significant ocular disease that might interfere with the study as deemed by the Investigator.
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Recent or current evidence of ocular infection or inflammation in either eye.
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Any history of herpes simplex or herpes zoster keratitis.
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History of diabetic retinopathy or diabetic macular edema.
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Known allergy, hypersensitivity, or contraindication to any component of the phentolamine, pilocarpine, or vehicle formulations.
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History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal.
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Ocular trauma, ocular surgery, ocular laser treatment within the 6 months prior to Screening. Any subject with multifocal intraocular lenses are excluded.
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History of any traumatic (surgical or nonsurgical) or non traumatic condition affecting the pupil or iris.
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Unwilling or unable to discontinue use of contact lenses.
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Conjunctival hyperemia ≥ grade 2 on the CCLRU 4-point scale.
Systemic:
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Known hypersensitivity or contraindication to alpha- and/or beta adrenoceptor antagonists.
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Known hypersensitivity or contraindication to any systemic cholinergic parasympathomimetic agents.
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Clinically significant systemic disease that might interfere with the study as deemed by the Investigator.
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Participation in any investigational study within 30 days prior to Screening.
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Females of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.
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Resting HR outside the specified range of 50 to 110 beats per minute.
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Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHg.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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 |
5 | Clinical Site 11 | Maitland | Florida | United States | 32751 |
6 | Clinical Site 8 | Sarasota | Florida | United States | 34239 |
7 | Clinical Site 10 | Roswell | Georgia | United States | 30041 |
8 | Clinical Site 3 | Pittsburg | Kansas | United States | 66762 |
9 | Clinical Site 18 | Saint Louis | Missouri | United States | 63101 |
10 | Clinical Site 16 | Poughkeepsie | New York | United States | 12603 |
11 | Clinical Site 14 | Fargo | North Dakota | United States | 58103 |
12 | Clinical Site 2 | Athens | Ohio | United States | 45701 |
13 | Clinical Site 9 | Cincinnati | Ohio | United States | 45242 |
14 | Clinical Site 7 | Cleveland | Ohio | United States | 44115 |
15 | Clinical Site 15 | Powell | Ohio | United States | 43065 |
16 | Clinical Site 4 | Warwick | Rhode Island | United States | 02888 |
17 | Clinical Site 1 | Memphis | Tennessee | United States | 38119 |
Sponsors and Collaborators
- Ocuphire Pharma, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OPI-NYXP-201 (VEGA-1)