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

Sponsor
Ocuphire Pharma, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04675151
Collaborator
(none)
150
17
4
4.4
8.8
2

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
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 :
Feb 15, 2021
Actual Primary Completion Date :
May 17, 2021
Actual Study Completion Date :
Jun 30, 2021

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Percent of subjects with ≥ 15 letters of improvement in photopic binocular DCNVA [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 [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 [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 [up to 6 hours]

      The percentage of subjects with improvement in BCIVA (photopic) from Baseline of ≥ 5, ≥ 10, and ≥ 15 letters

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:
    1. Known hypersensitivity or contraindication to alpha- and/or beta adrenoceptor antagonists.

    2. Known hypersensitivity or contraindication to any systemic cholinergic parasympathomimetic agents.

    3. Clinically significant systemic disease that might interfere with the study as deemed by the Investigator.

    4. Participation in any investigational study within 30 days prior to Screening.

    5. Females of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.

    6. Resting HR outside the specified range of 50 to 110 beats per minute.

    7. Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHg.

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Ocuphire Pharma, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ocuphire Pharma, Inc.
    ClinicalTrials.gov Identifier:
    NCT04675151
    Other Study ID Numbers:
    • OPI-NYXP-201 (VEGA-1)
    First Posted:
    Dec 19, 2020
    Last Update Posted:
    Jun 22, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ocuphire Pharma, Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 22, 2022