Phase 2 Clinical Trial of Phentolamine Ophthalmic Solution 0.75% in Elderly Subjects with Glaucoma

About the Trial

Safety and Efficacy of Ophthalmic Phentolamine Mesylate in Glaucoma (NCT03960866)

Placebo-controlled double-masked, multiple dose Phase 2 study in 40 patients with IOP ≥ 22 and ≤30 mmHg, evaluating ocular and systemic safety and efficacy following administration of Phentolamine Ophthalmic Solution 0.75% (phentolamine mesylate 1.0%) QD at 8PM to 10PM in both eyes for 14 days.

Detailed Info

The objectives of this study are:* To evaluate the efficacy of Phentolamine Mesylate to lower intra-ocular pressure (IOP) in the treatment of Open-Angle Glaucoma (OAG) and Ocular Hypertension (OHT). * To evaluate the ocular and systemic safety of Phentolamine Mesylate compared to its vehicle. * To evaluate additional efficacy of Phentolamine Mesylate to improve visual performance.

Study Phase

Phase 2

Estimated Enrollment


Estimated Primary Completion Date

September 11, 2019

Study Type


  • Drug: Phentolamine Mesylate Ophthalmic Solution 1%
  • Other: Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)

Ocuphire Pharma, Inc.


Inclusion Criteria

  • Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT). A reported history of untreated OHT with IOP ≥22mmHg and ≤ 30mmHg is preferred.
  • Untreated or treated OAG/OHT with 2 or fewer ocular hypotensive medications.
  • Untreated (post-washout) mean IOP ≥ 22mmHg and ≤30mmHg in the study eye at the Qualification Visit (8AM).
  • Corrected visual acuity in each eye +1.0 logMAR or better by Early Treatment Diabetic Retinopathy Study (ETDRS) in each eye (equivalent to 20/200 or better) at the Screening Visit and Qualification Visit.
  • Otherwise healthy and well-controlled subjects.
  • Able and willing to give signed informed consent and follow study instructions.
  • Able to self-administer study medication or to have study medication administered by a caregiver throughout the study period.

Exclusion Criteria

  • Closed or very narrow angles (Grade 0-1, Shaffer)
  • Glaucoma: pseudo-exfoliation or pigment dispersion component
  • Known hypersensitivity to any α-adrenoceptor antagonists
  • Previous laser and/or non-laser glaucoma surgery or procedure in either eye
  • Refractive surgery in either eye
  • Ocular trauma in either eye within the 6 months prior to Screening, or ocular surgery or non-refractive laser treatment within the 3 months prior to Screening
  • Recent or current evidence of ocular infection or inflammation in either eye
  • Ocular medication in either eye of any kind within 30 days of Screening
  • Clinically significant ocular disease in either eye
  • History of diabetic retinopathy
  • Contact lens wear within 3 days prior to and for the duration of the study
  • Central corneal thickness in either eye >600 μm at Screening
  • Any abnormality in either eye preventing reliable applanation tonometry
  • Known hypersensitivity or contraindication to α- and/or β-adrenoceptor antagonists
  • Clinically significant systemic disease that might interfere with the study
  • Participation in any investigational study within 30 days prior to Screening
  • Use of any topical or systemic adrenergic or cholinergic drugs up to 30 days prior to Screening, or during the study
  • Changes in systemic medication that could have an effect on IOP within 30 days prior to Screening
  • Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control
  • Resting heart rate outside the normal range (50-110 beats per minute) at Screening or Qualification Visit
  • Hypertension with resting diastolic blood pressure (BP) > 105 mmHg or systolic BP > 160 mmHg at the Screening or Qualification Visit


The following cities were clinical trial sites.