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Safety and Efficacy of Nyxol With Pilocarpine Eye Drops in Subjects With Presbyopia

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ClinicalTrials.gov Identifier: NCT04675151
Recruitment Status : Completed
First Posted : December 19, 2020
Last Update Posted : November 15, 2021
Sponsor:
Information provided by (Responsible Party):
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


Condition or disease Intervention/treatment Phase
Presbyopia Drug: Phentolamine Ophthalmic Solution 0.75% Drug: Pilocarpine Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) With Pilocarpine Eye Drops in Subjects With Presbyopia
Actual Study Start Date : February 15, 2021
Actual Primary Completion Date : May 17, 2021
Actual Study Completion Date : May 17, 2021


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:
  • Nyxol
  • Nyxol®

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:
  • Nyxol
  • Nyxol®

Active Comparator: Pilocarpine
1 drop of Pilocarpine (Treatment 2)
Drug: Pilocarpine
Pilocarpine ophthalmic solution

Other: Placebo
Topical sterile ophthalmic solution
Other Name: Phentolamine Ophthalmic Solution Vehicle

Placebo Comparator: Placebo
1 drop of Placebo (Treatment 1)
Other: Placebo
Topical sterile ophthalmic solution
Other Name: Phentolamine Ophthalmic Solution Vehicle




Primary Outcome Measures :
  1. Percent of subjects with ≥ 15 letters of improvement in photopic binocular DCNVA [ Time Frame: up to 6 hours ]
    The percent of subjects with ≥ 15 letters of improvement in photopic binocular DCNVA


Secondary Outcome Measures :
  1. Percentage of subjects with improvement of ≥ 5, ≥ 10, and ≥ 15 letters in DCNVA (photopic) from Baseline [ Time Frame: up to 6 hours ]
    The percentage of subjects with improvement of ≥ 5, ≥ 10, and ≥ 15 letters in DCNVA (photopic) from Baseline

  2. 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 [ Time Frame: 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

  3. Percentage of subjects with improvement in BCIVA (photopic) from Baseline [ Time Frame: up to 6 hours ]
    The percentage of subjects with improvement in BCIVA (photopic) from Baseline of ≥ 5, ≥ 10, and ≥ 15 letters



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 ≤ 64years of age.
  2. BCDVA of 0.0 LogMAR(20/20 Snellen equivalent) or better in each eye under photopic conditions.
  3. DCNVA of 0.4 LogMAR (20/50 Snellen equivalent) or worse under photopic conditions in each eye and binocularly.
  4. 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):

  1. Use of any topical prescription or OTC ophthalmic medications of any kind within 7 days of Screening until study completion.
  2. 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.
  3. Current use of any topical ophthalmic therapy for dry eye.
  4. Tear break-up time of < 5 seconds or corneal fluorescein staining.
  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. History of diabetic retinopathy or diabetic macular edema.
  9. Known allergy, hypersensitivity, or contraindication to any component of the phentolamine, pilocarpine, or vehicle formulations.
  10. History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal.
  11. Ocular trauma, ocular surgery, ocular laser treatment within the 6 months prior to Screening. Any subject with multifocal intraocular lenses are excluded.
  12. History of any traumatic (surgical or nonsurgical) or non traumatic condition affecting the pupil or iris.
  13. Unwilling or unable to discontinue use of contact lenses.
  14. Conjunctival hyperemia ≥ grade 2 on the CCLRU 4-point scale.

    Systemic:

  15. Known hypersensitivity or contraindication to alpha- and/or beta adrenoceptor antagonists.
  16. Known hypersensitivity or contraindication to any systemic cholinergic parasympathomimetic agents.
  17. Clinically significant systemic disease that might interfere with the study as deemed by the Investigator.
  18. Participation in any investigational study within 30 days prior to Screening.
  19. Females of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.
  20. Resting HR outside the specified range of 50 to 110 beats per minute.
  21. Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHg.

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): NCT04675151


Locations
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Sponsors and Collaborators
Ocuphire Pharma, Inc.
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Responsible Party: Ocuphire Pharma, Inc.
ClinicalTrials.gov Identifier: NCT04675151    
Other Study ID Numbers: OPI-NYXP-201 (VEGA-1)
First Posted: December 19, 2020    Key Record Dates
Last Update Posted: November 15, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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