VEGA-2 Pivotal Phase 3 Trial of Phentolamine Ophthalmic Solution 0.75% in Presbyopia

About the Trial

VEGA-2 Pivotal Phase 3 Trial of Phentolamine Ophthalmic Solution 0.75%® in Presbyopia (NCT05646719)

VEGA-2 is a randomized, double-masked, placebo-controlled, multi-center, Phase 3 study to evaluate Phentolamine Ophthalmic Solution 0.75% in Subjects with Presbyopia.

Detailed Info

The objectives of this study are:To evaluate the safety and efficacy of Nyxol alone and with adjunctive low dose pilocarpine to improve distance-corrected near visual acuity (DCNVA) in subjects with presbyopia.

Study Phase

Phase 3

Estimated Enrollment


Estimated Primary Completion Date

October 11, 2023

Study Type


  • Drug: Phentolamine Opthalmic Solution 0.75%
  • Other: Placebo
  • Drug: Low dose pilocarpine
  • Other: Low dose pilocarpine vehicle

Ocuphire Pharma, Inc.


Inclusion Criteria

  • Males or females ≥ 40 and ≤ 64 years of age.
  • BCDVA of 0.1 LogMAR (20/25 Snellen equivalent) or better in each eye in photopic conditions.
  • DCNVA of 0.4 LogMAR (20/50 Snellen equivalent) or worse but not > 0.7 LogMAR (20/100 Snellen equivalent) in photopic conditions in each eye and binocularly.
  • For subjects who depend on reading glasses or bifocals, binocular best-corrected near VA is 0.1 LogMAR (20/25 Snellen equivalent) or better.
  • Photopic PD of ≥ 3 mm in either eye.

Exclusion Criteria

Ophthalmic (in either eye):

  • Use of any topical prescription or over-the-counter (OTC) ophthalmic medications of any kind within 7 days of Screening until study completion, with the exception of lid scrubs with OTC products and artificial tears as specified in Exclusion # 2 below.
  • Use of any OTC artificial tears (preserved or unpreserved) during Visit days or 15 min before or after instillation of study medication.
  • Current use of any topical ophthalmic therapy for dry eye.
  • Tear break-up time of < 5 seconds or corneal fluorescein staining Grade ≥ 2 in the inferior zone or Grade ≥ 1 in the central zone using the National Eye Institute scale..
  • Clinically significant ocular disease that might interfere with the study as deemed by the Investigator.
  • Recent or current evidence of ocular infection or inflammation in either eye.
  • Any history of herpes simplex or herpes zoster keratitis.
  • Known allergy, hypersensitivity, or contraindication to any component of the phentolamine, pilocarpine, or vehicle formulations.
  • Prior participation in a study involving the use of Phentolamine Ophthalmic Solution 0.75% for the treatment of presbyopia.
  • History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal.
  • Ocular trauma within 6 months prior to Screening.
  • Ocular surgery or any ocular laser treatment within 6 months prior to Screening.
  • Subjects with surgical monovision, multifocal or extended depth of focus intraocular lenses (IOLs) are excluded.
  • History of any traumatic (surgical or nonsurgical) or nontraumatic condition affecting the pupil or iris.
  • Contact lens wear on the day of any study visit and contact lenses must be removed for home dosing and for at least 10 minutes following dosing.


  • Known hypersensitivity or contraindication to alpha- and/or beta-adrenoceptor antagonists .
  • Known hypersensitivity or contraindication to any systemic cholinergic parasympathomimetic agent.
  • Clinically significant systemic disease that might interfere with the study as deemed by the judgment of the Investigator.
  • Initiation of treatment with, or any changes to, the current dosage, drug, or regimen of any systemic adrenergic or cholinergic drugs within 7 days prior to Screening or during the study.
  • Participation in any investigational study within 30 days prior to Screening.
  • Females of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.
  • Resting HR outside the range of 50 to 110 beats per min.
  • Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHg.



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The safety and efficacy of the investigational use of these products have not been determined. There is no guarantee that the investigational use listed will be filed with and/or approved for marketing by a regulatory agency.