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Safety and Efficacy of Nyxol Eye Drops as a Single Agent and With Adjunctive Low-Dose Pilocarpine Eye Drops in Subjects With Presbyopia (VEGA-2)

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ClinicalTrials.gov Identifier: NCT05646719
Recruitment Status : Recruiting
First Posted : December 12, 2022
Last Update Posted : April 26, 2023
Sponsor:
Information provided by (Responsible Party):
Ocuphire Pharma, Inc.

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Presbyopia Drug: Phentolamine Opthalmic Solution 0.75% Other: Placebo Drug: Low dose pilocarpine Other: Low dose pilocarpine vehicle Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 22, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Nyxol + low dose pilocarpine Drug: Phentolamine Opthalmic Solution 0.75%
phentolamine ophthalmic solution 0.75% (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
Other Name: Nyxol

Drug: Low dose pilocarpine
Pilocarpine hydrochloride ophthalmic solution 0.4%
Other Names:
  • Pilocarpine
  • LDP
Experimental: Nyxol + low dose pilocarpine vehicle Drug: Phentolamine Opthalmic Solution 0.75%
phentolamine ophthalmic solution 0.75% (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
Other Name: Nyxol

Other: Low dose pilocarpine vehicle
Vehicle for low dose pilocarpine
Experimental: Placebo + low dose pilocarpine Other: Placebo
Vehicle for Phentolamine Ophthalmic Solution
Other Name: Phentolamine Ophthalmic Solution Vehicle

Drug: Low dose pilocarpine
Pilocarpine hydrochloride ophthalmic solution 0.4%
Other Names:
  • Pilocarpine
  • LDP
Placebo Comparator: Placebo + low dose pilocarpine vehicle Other: Placebo
Vehicle for Phentolamine Ophthalmic Solution
Other Name: Phentolamine Ophthalmic Solution Vehicle

Other: Low dose pilocarpine vehicle
Vehicle for low dose pilocarpine


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: Visit 2 at 12 hours post-Nxyol/placebo ]
    The percent of subjects with ≥ 15 letters of improvement in photopic binocular DCNVA and with < 5 letters of loss in photopic binocular BCDVA from Baseline in Nyxol-treated subjects at 12 hours post-Nyxol/placebo at Visit 2


Secondary Outcome Measures :
  1. Percent of subjects with ≥ 15 letters improvement in photopic binocular DCNVA and with < 5 letters of loss in photopic binocular BCDVA in LDP+Nyxol-treated subjects [ Time Frame: Visit 5 at 0.5 hours post-LDP/vehicle ]
    The percent of subjects with ≥ 15 letters of improvement in photopic binocular DCNVA and with < 5 letters of loss in photopic binocular BCDVA at 0.5 hours post-LDP/vehicle at Visit 5

  2. Percent of subjects with ≥ 15 letters improvement in photopic binocular DCNVA and with < 5 letters of loss in photopic binocular BCDVA in Nyxol-treated subjects [ Time Frame: Visit 2 at 0.5, 1, 3, 5 and 8 hours post-Nyxol/placebo ]
    The percent of subjects with ≥ 15 letters of improvement in photopic binocular DCNVA and with < 5 letters of loss in photopic binocular BCDVA from Baseline in Nyxol-treated subjects at 0.5, 1, 3, 5 and 8 hours post-Nyxol/placebo at Visit 2

  3. Percent of subjects with ≥ 15 letters improvement in photopic binocular DCNVA and with < 5 letters of loss in in photopic binocular BCDVA in LDP+Nyxol-treated subjects [ Time Frame: Visit 5 at 1, 3, 5 and 8 hours post-LDP/vehicle ]
    The percent of subjects with ≥ 15 letters of improvement in photopic binocular DCNVA and with < 5 letters of loss in photopic binocular BCDVA at 1, 3, 5 and 8 hours post-LDP/vehicle in LDP+Nyxol-treated subjects at Visit 5

  4. Percentage of subjects with ≥ 5, ≥ 10, and ≥ 15 letters of improvement in photopic binocular distance-corrected intermediate visual acuity (DCIVA) from Baseline in Nyxol-treated subjects [ Time Frame: Visit 2 at 0.5, 1, 3, 5, 8 and 12 hours post-Nyxol/placebo ]
    Percentage of subjects with ≥ 5, ≥ 10, and ≥ 15 letters of improvement in photopic binocular DCIVA from Baseline in Nyxol-treated subjects at 0.5, 1, 3, 5, 8 and 12 hours post-Nyxol/placebo at Visit 2

  5. Percentage of subjects with ≥ 5, ≥ 10, and ≥ 15 letters of improvement in photopic binocular DCIVA from Baseline in LDP+Nyxol-treated subjects [ Time Frame: Visit 5 at 0.5, 1, 3, 5 and 8 hours post-LDP/vehicle ]
    Percentage of subjects with ≥ 5, ≥ 10, and ≥ 15 letters of improvement in photopic binocular DCIVA from Baseline in LDP+Nyxol-treated subjects at 0.5, 1, 3, 5 and 8 hours post-LDP/vehicle on Visit 5


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05646719


Contacts
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Contact: Drey Coleman 248-681-9815 dcoleman@ocuphire.com

Locations
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Sponsors and Collaborators
Ocuphire Pharma, Inc.
More Information
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Responsible Party: Ocuphire Pharma, Inc.
ClinicalTrials.gov Identifier: NCT05646719    
Other Study ID Numbers: OPI-NYXP-301 (VEGA-2)
First Posted: December 12, 2022    Key Record Dates
Last Update Posted: April 26, 2023
Last Verified: April 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ocuphire Pharma, Inc.:
Nyxol
Presbyopia
Pilocarpine
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases
Phentolamine
Pharmaceutical Solutions
Ophthalmic Solutions
Pilocarpine
Miotics
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Antihypertensive Agents