VEGA-1: Presbyopia Phase 2 Clinical Trial for Nyxol with Low-Dose Pilocarpine

About the Trial

VEGA-1: Presbyopia Phase 2 Clinical Trial for Nyxol with Low-Dose Pilocarpine (NCT04675151)

Randomized, Placebo-Controlled, Double-Masked Study of the Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) With Low-Dose (0.4%) Pilocarpine Eye Drops in Subjects With Presbyopia

Detailed Info

The objectives of this study are:

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

Study Phase

Phase 2

Estimated Enrollment

150

Estimated Primary Completion Date

June 2021

Study Type

Interventional

Interventions
  • Drug: Phentolamine Ophthalmic Solution 0.75%
  • Drug: Pilocarpine
  • Other: Placebo
Sponsor

Ocuphire Pharma, Inc.

Eligibility

Inclusion Criteria

  • Males or females ≥ 40 and≤64years of age.
  • BCDVA of 0.0 LogMAR(20/20 Snellen equivalent) or better in each eye under photopic conditions.
  • DCNVA of 0.4 LogMAR (20/50 Snellen equivalent) or worse under photopic conditions in each eye and binocularly.
  • 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):

  • Use of any topical prescription or OTC ophthalmic medications of any kind within 7 days of Screening until study completion.
  • 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.
  • Current use of any topical ophthalmic therapy for dry eye.
  • Tear break-up time of < 5 seconds or corneal fluorescein staining.
  • 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.
  • History of diabetic retinopathy or diabetic macular edema.
  • Known allergy, hypersensitivity, or contraindication to any component of the phentolamine, pilocarpine, or vehicle formulations.
  • History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal.
  • Ocular trauma, ocular surgery, ocular laser treatment within the 6 months prior to Screening. Any subject with multifocal intraocular lenses are excluded.
  • History of any traumatic (surgical or nonsurgical) or non traumatic condition affecting the pupil or iris.
  • Unwilling or unable to discontinue use of contact lenses.
  • Conjunctival hyperemia ≥ grade 2 on the CCLRU 4-point scale.

Systemic:

  • Known hypersensitivity or contraindication to alpha- and/or beta adrenoceptor antagonists.
  • Known hypersensitivity or contraindication to any systemic cholinergic parasympathomimetic agents.
  • Clinically significant systemic disease that might interfere with the study as deemed by the Investigator.
  • 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 specified range of 50 to 110 beats per minute.
  • Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHg.

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