Safety and Efficacy of Nyxol With Pilocarpine Eye Drops in Subjects With Presbyopia
- Conditions
- Presbyopia
- Interventions
- Registration Number
- NCT04675151
- Lead Sponsor
- Ocuphire Pharma, Inc.
- Brief Summary
The objectives of this study are:
To evaluate the efficacy of Nyxol + Pilocarpine to improve DCNVA in subjects with presbyopia
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- 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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nyxol + Pilocarpine Phentolamine Ophthalmic Solution 0.75% 1 drop of Nyxol (Treatment 1) and 1 drop of Pilocarpine (Treatment 2) Pilocarpine Pilocarpine 1 drop of Pilocarpine (Treatment 2) Placebo Placebo 1 drop of Placebo (Treatment 1) Nyxol Phentolamine Ophthalmic Solution 0.75% 1 drop of Nyxol (Treatment 1) Pilocarpine Placebo 1 drop of Pilocarpine (Treatment 2) Nyxol + Pilocarpine Pilocarpine 1 drop of Nyxol (Treatment 1) and 1 drop of Pilocarpine (Treatment 2)
- Primary Outcome Measures
Name Time Method Percent of Subjects With ≥ 15 Letters of Improvement in Photopic Binocular DCNVA Visit 2 at 1 hour The primary efficacy endpoint was the percent of subjects with ≥ 15 letters of improvement in photopic binocular DCNVA on Visit 2 at 1 hour with POS + LDP compared to placebo alone. The improvement in binocular DCNVA for each subject was relative to the subject's own baseline value (Visit 1).
- Secondary Outcome Measures
Name Time Method Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline Visit 2 at 0.5 hours, at 2 hours, at 3 hours, at 4 hours, and at 6 hours The percentage of subjects with improvement of ≥ 5, ≥ 10, and ≥ 15 letters in DCNVA (photopic) from Baseline at 0.5 hours, at 2 hours, at 3 hours, at 4 hours, and at 6 hours
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 Visit 2 at 1 hour 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 DCIVA (Photopic) From Baseline Visit 2 at 1 hour, at 3 hours, and at 6 hours The percentage of subjects with improvement in DCIVA (photopic) from Baseline of ≥ 5, ≥ 10, and ≥ 15 letters
Trial Locations
- Locations (17)
Clinical Site 18
🇺🇸Saint Louis, Missouri, United States
Clinical Site 12
🇺🇸Laguna Hills, California, United States
Clinical Site 3
🇺🇸Pittsburg, Kansas, United States
Clinical Site 13
🇺🇸Crystal River, Florida, United States
Clinical Site 9
🇺🇸Cincinnati, Ohio, United States
Clinical Site 11
🇺🇸Maitland, Florida, United States
Clinical Site 6
🇺🇸Newport Beach, California, United States
Clinical Site 10
🇺🇸Roswell, Georgia, United States
Clinical Site 16
🇺🇸Poughkeepsie, New York, United States
Clinical Site 15
🇺🇸Powell, Ohio, United States
Clinical Site 7
🇺🇸Cleveland, Ohio, United States
Clinical Site 2
🇺🇸Athens, Ohio, United States
Clinical Site 4
🇺🇸Warwick, Rhode Island, United States
Clinical Site 14
🇺🇸Fargo, North Dakota, United States
Clinical Site 1
🇺🇸Memphis, Tennessee, United States
Clinical Site 8
🇺🇸Sarasota, Florida, United States
Clinical Site 5
🇺🇸Longwood, Florida, United States