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

September 30, 2025 updated by: Ocuphire Pharma, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
      • St 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

36 years to 60 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent of Subjects With ≥ 15 Letters of Improvement in Photopic Binocular DCNVA
Time Frame: 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).
Visit 2 at 1 hour

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline
Time Frame: 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
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
Time Frame: 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
Visit 2 at 1 hour
Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline
Time Frame: 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
Visit 2 at 1 hour, at 3 hours, and at 6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ocuphire Pharma, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 17, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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