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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04675151
Recruitment Status : Active, not recruiting
First Posted : December 19, 2020
Last Update Posted : June 25, 2021
Sponsor:
Information provided by (Responsible Party):
Ocuphire Pharma, Inc.

Tracking Information
First Submitted Date  ICMJE December 15, 2020
First Posted Date  ICMJE December 19, 2020
Last Update Posted Date June 25, 2021
Actual Study Start Date  ICMJE February 15, 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2020)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Nyxol With Pilocarpine Eye Drops in Subjects With Presbyopia
Official Title  ICMJE Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) With Pilocarpine Eye Drops in Subjects With Presbyopia
Brief Summary

The objectives of this study are:

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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Presbyopia
Intervention  ICMJE
  • 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
  • Other: Placebo
    Topical sterile ophthalmic solution
    Other Name: Phentolamine Ophthalmic Solution Vehicle
Study Arms  ICMJE
  • Experimental: Nyxol + Pilocarpine
    1 drop of Nyxol (Treatment 1) and 1 drop of Pilocarpine (Treatment 2)
    Interventions:
    • Drug: Phentolamine Ophthalmic Solution 0.75%
    • Drug: Pilocarpine
  • Active Comparator: Nyxol
    1 drop of Nyxol (Treatment 1)
    Intervention: Drug: Phentolamine Ophthalmic Solution 0.75%
  • Active Comparator: Pilocarpine
    1 drop of Pilocarpine (Treatment 2)
    Interventions:
    • Drug: Pilocarpine
    • Other: Placebo
  • Placebo Comparator: Placebo
    1 drop of Placebo (Treatment 1)
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 23, 2021)
150
Original Estimated Enrollment  ICMJE
 (submitted: December 15, 2020)
152
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04675151
Other Study ID Numbers  ICMJE OPI-NYXP-201 (VEGA-1)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ocuphire Pharma, Inc.
Study Sponsor  ICMJE Ocuphire Pharma, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ocuphire Pharma, Inc.
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP