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

NCT ID: NCT04675151

Last Updated: 2025-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-15
• Study Completion Date: 2021-06-30

Brief Summary

The objectives of this study are:

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

Conditions

Presbyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Nyxol + Pilocarpine

1 drop of Nyxol (Treatment 1) and 1 drop of Pilocarpine (Treatment 2)

Group Type: EXPERIMENTAL

Phentolamine Ophthalmic Solution 0.75%

Intervention Type: DRUG

0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist

Pilocarpine

Intervention Type: DRUG

Pilocarpine ophthalmic solution

Nyxol

1 drop of Nyxol (Treatment 1)

Group Type: ACTIVE_COMPARATOR

Phentolamine Ophthalmic Solution 0.75%

Intervention Type: DRUG

0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist

Pilocarpine

1 drop of Pilocarpine (Treatment 2)

Group Type: ACTIVE_COMPARATOR

Pilocarpine

Intervention Type: DRUG

Pilocarpine ophthalmic solution

Placebo

Intervention Type: OTHER

Topical sterile ophthalmic solution

Placebo

1 drop of Placebo (Treatment 1)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Topical sterile ophthalmic solution

Interventions

Phentolamine Ophthalmic Solution 0.75%

0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist

Intervention Type: DRUG

Pilocarpine

Pilocarpine ophthalmic solution

Intervention Type: DRUG

Placebo

Topical sterile ophthalmic solution

Intervention Type: OTHER

Other Intervention Names

Nyxol; Nyxol®; Phentolamine Ophthalmic Solution Vehicle

Eligibility 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ocuphire Pharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Site 12

Laguna Hills, California, United States

Clinical Site 6

Newport Beach, California, United States

Clinical Site 13

Crystal River, Florida, United States

Clinical Site 5

Longwood, Florida, United States

Clinical Site 11

Maitland, Florida, United States

Clinical Site 8

Sarasota, Florida, United States

Clinical Site 10

Roswell, Georgia, United States

Clinical Site 3

Pittsburg, Kansas, United States

Clinical Site 18

St Louis, Missouri, United States

Clinical Site 16

Poughkeepsie, New York, United States

Clinical Site 14

Fargo, North Dakota, United States

Clinical Site 2

Athens, Ohio, United States

Clinical Site 9

Cincinnati, Ohio, United States

Clinical Site 7

Cleveland, Ohio, United States

Clinical Site 15

Powell, Ohio, United States

Clinical Site 4

Warwick, Rhode Island, United States

Clinical Site 1

Memphis, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

OPI-NYXP-201 (VEGA-1)

Identifier Type: -

Identifier Source: org_study_id