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

Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) With Pilocarpine Eye Drops in Subjects With Presbyopia

The objectives of this study are:

To evaluate the efficacy of Nyxol + Pilocarpine to improve DCNVA in subjects with presbyopia

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Drug: Phentolamine Ophthalmic Solution 0.75%; Drug: Pilocarpine; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Laguna Hills, California, United States, 92653
      • Clinical Site 12
    • Newport Beach, California, United States, 92663
      • Clinical Site 6
  • Florida
    • Crystal River, Florida, United States, 34461
      • Clinical Site 13
    • Longwood, Florida, United States, 32779
      • Clinical Site 5
    • Maitland, Florida, United States, 32751
      • Clinical site 11
    • Sarasota, Florida, United States, 34239
      • Clinical Site 8
  • Georgia
    • Roswell, Georgia, United States, 30041
      • Clinical Site 10
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Clinical Site 3
  • Missouri
    • Saint Louis, Missouri, United States, 63101
      • Clinical Site 18
  • New York
    • Poughkeepsie, New York, United States, 12603
      • Clinical site 16
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Clinical Site 14
  • Ohio
    • Athens, Ohio, United States, 45701
      • Clinical Site 2
    • Cincinnati, Ohio, United States, 45242
      • Clinical Site 9
    • Cleveland, Ohio, United States, 44115
      • Clinical Site 7
    • Powell, Ohio, United States, 43065
      • Clinical Site 15
  • Rhode Island
    • Warwick, Rhode Island, United States, 02888
      • Clinical Site 4
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Clinical Site 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 62 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / 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 Names: Phentolamine Ophthalmic Solution Vehicle
Placebo Comparator: Placebo; 1 drop of Placebo (Treatment 1)	Other: Placebo; Topical sterile ophthalmic solution; Other Names: Phentolamine Ophthalmic Solution Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Subjects With ≥ 15 Letters of Improvement in Photopic Binocular DCNVA	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).	Visit 2 at 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline	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	Visit 2 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	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	Visit 2 at 1 hour
Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline	The percentage of subjects with improvement in DCIVA (photopic) from Baseline of ≥ 5, ≥ 10, and ≥ 15 letters	Visit 2 at 1 hour, at 3 hours, and at 6 hours

Collaborators and Investigators

• Sponsor: Ocuphire Pharma, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2021
• Primary Completion (Actual): May 17, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: December 15, 2020
• First Submitted That Met QC Criteria: December 15, 2020
• First Posted (Actual): December 19, 2020

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: August 11, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Presbyopia; Nyxol; Pilocarpine
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Cholinergic Agonists; Adrenergic alpha-Antagonists; Miotics; Muscarinic Agonists; Ophthalmic Solutions; Pharmaceutical Solutions; Pilocarpine; Phentolamine
• Other Study ID Numbers: OPI-NYXP-201 (VEGA-1)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No