Evaluate Efficacy and Safety of POS to Improve Distance-corrected Near Visual in Participants With Presbyopia

Last updated: February 28, 2025
Sponsor: Ocuphire Pharma, Inc.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Presbyopia

Treatment

Placebo

0.75% phentolamine ophthalmic solution

Clinical Study ID

NCT06542497
OPI-NYXP-302
  • Ages 45-64
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Safety and efficacy of POS in participants with presbyopia

Eligibility Criteria

Inclusion

Inclusion Criteria:

Participants must meet all of the following criteria:

  1. Males or females ≥ 45 and ≤ 64 years of age

  2. Able to comply with all protocol-mandated procedures independently and to attend allscheduled office visits

  3. Able and willing to give signed informed consent

  4. Able to self-administer study medication throughout the study period Inclusion criteria #5, #6, and #7 must all be met at both Screening and BaselineVisits:

  5. BCDVA of 55 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (20/20Snellen equivalent) or better in photopic conditions in each eye

  6. DCNVA of 50 ETDRS letters (20/50 Snellen equivalent) or worse but not <35 ETDRSletters (20/100 Snellen equivalent) in photopic conditions in each eye andbinocularly

  7. For participants who depend on reading glasses or bifocals, binocular best-correctednear VA of 65 ETDRS letters (20/25 Snellen equivalent) or better

  8. Photopic PD of ≥ 4 mm in the study eye at Screening

Exclusion

Exclusion Criteria:

Excluded from the study will be individuals with any of the following characteristics:

Ophthalmic (in either eye):

  1. Use of any topical prescription (including Vuity® or Qlosi™) or over-the-counter (OTC) ophthalmic medications of any kind within 7 days of Screening until studycompletion, with the exception of lid scrubs with OTC products (eg, OCuSOFT® lidscrub, SteriLid®, baby shampoo, etc.) and artificial tears as specified in ExclusionCriterion #2 below

  2. Use of any OTC artificial tears (preserved or unpreserved) during visit days or 15min before or after instillation of study medication

  3. Use of Ryzumvi™ (POS) within 7 days prior to Screening

  4. Use of any dry eye product, such as topical ophthalmic therapy for dry eye (eg,generic cyclosporine, Restasis®, Xiidra®, Cequa®, Eysuvis®, and Meibo®) orintranasal dry eye product (eg, Tyrvaya®) or other devices within 12 months prior toScreening

  5. Tear break-up time of < 5 seconds or corneal fluorescein staining (CFS) Grade ≥ 2 inthe inferior zone or Grade ≥ 1 in the central zone using the National Eye Institutescale

  6. Clinically significant ocular disease (eg, cataract, glaucoma, corneal edema,uveitis, retinal degeneration, loss of visual field, or any macular pathology) that,in the judgment of the Investigator, might interfere with study procedures

  7. Recent or current evidence of ocular infection or inflammation in either eye (suchas current evidence of clinically significant blepharitis, conjunctivitis,keratitis, etc.). Participants must be symptom free for at least 7 days prior toScreening

  8. Any history of herpes simplex or herpes zoster keratitis

  9. Known allergy, hypersensitivity, or contraindication to any component of thephentolamine or vehicle formulations

  10. Prior participation in a study involving the use of POS for the treatment ofpresbyopia or night vision disturbance

  11. History of cauterization of the punctum or punctal plug (silicone or collagen)insertion or removal

  12. Ocular trauma within 6 months prior to Screening

  13. Ocular surgery or any ocular laser treatment within 6 months prior to Screening. Anyhistory of radial keratotomy is prohibited

  14. Participants with surgical monovision, multifocal, or extended depth-of-focusintraocular lenses (IOLs). Monofocal IOLs are acceptable if in place > 6 monthsprior to Screening

  15. Monofocal IOL in place > 6 months prior to Screening with any posterior capsuleopacification

  16. History of any traumatic (surgical or nonsurgical) or nontraumatic conditionaffecting the pupil or iris (eg, irregularly shaped pupil, neurogenic pupildisorder, iris atrophy, iridotomy, iridectomy, iritis, etc.)

  17. Unwilling or unable to discontinue use of contact lenses at least 1 hour prior toScreening for soft contact lenses or at least 8 hours prior to Screening for hardgas permeable contact lenses, and at least 8 hours (for both types of lenses) priorto all other office visits Systemic:

  18. Known hypersensitivity or contraindication to alpha- and/or beta-adrenoceptorantagonists (eg, chronic obstructive pulmonary disease or bronchial asthma;abnormally low blood pressure (BP) or heart rate (HR); second- or third-degree heartblockage or congestive heart failure)

  19. Known hypersensitivity or contraindication to any systemic cholinergicparasympathomimetic agent

  20. Clinically significant systemic disease (eg, uncontrolled diabetes, myastheniagravis, cancer, hepatic, renal, endocrine, or cardiovascular disorders) that mightinterfere with the study as deemed by the judgment of the Investigator

  21. Initiation of treatment with, or any changes to, the current dosage, drug, orregimen of any systemic adrenergic or cholinergic drugs within 7 days prior toScreening or during the study; however, Flomax® (tamsulosin) is specificallyexcluded

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

  23. Females of childbearing potential who are pregnant, nursing, planning a pregnancy,or not using a medically acceptable form of birth control. Acceptable methodsinclude the use of at least one of the following: intrauterine device, hormonalcontraception (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence. A female is considered to be of childbearingpotential unless she is 1 year postmenopausal or 3 months post-surgicalsterilization. All females of childbearing potential, including those withpost-tubal ligation, must have a negative urine pregnancy test result at Visit 1 (Screening)

  24. Resting HR outside the range of 50 to 110 beats per min (bpm) following at least a 5min rest period in the sitting position at Visit 1 (Screening). HR may be repeatedonly once if outside the specified range, following another 5 min rest period in thesitting position

  25. Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHgfollowing at least a 5-min rest period in the sitting position at Visit 1 (Screening). BP may be repeated only once if outside the specified range, followinganother 5-min rest period in the sitting position

Study Design

Total Participants: 545
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
August 15, 2024
Estimated Completion Date:
May 31, 2026

Study Description

Randomized, Double-Masked, Placebo-Controlled, Multicenter, Phase 3 Study of the Efficacy and Safety of Phentolamine Ophthalmic Solution (POS) 0.75% in Participants with Presbyopia

Connect with a study center

  • United States

    Phoenix, Arizona 85028
    United States

    Site Not Available

  • United States

    Scottsdale, Arizona 85260
    United States

    Site Not Available

  • United States

    Glendale, California 91204
    United States

    Site Not Available

  • United States

    Newport Beach, California 92663
    United States

    Site Not Available

  • United States

    Delray Beach, Florida 33484
    United States

    Site Not Available

  • United States

    Longwood, Florida 32779
    United States

    Site Not Available

  • United States

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • United States

    Rochester, New York 14618
    United States

    Site Not Available

  • United States

    Garner, North Carolina 27529
    United States

    Site Not Available

  • United States

    Athens, Ohio 45701
    United States

    Site Not Available

  • United States

    Warwick, Rhode Island 02888
    United States

    Site Not Available

  • United States

    Goodlettsville, Tennessee 37072
    United States

    Site Not Available

  • United States

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • United States

    San Antonio, Texas 78229
    United States

    Site Not Available

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