Safety and Efficacy of Ophthalmic Phentolamine Mesylate in Glaucoma

Completed · Phase 2 · Has a placebo group

Conditions studied: Open Angle Glaucoma, Ocular Hypertension

In brief

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.

Key facts

Study ID

NCT03960866

Run by

Ocuphire Pharma, Inc.

People needed

39

Starts

2019-05-28

Expected to finish

2019-09-11

Last updated by the study team

2023-09-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age or greater
• 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.

You may not qualify if…

• 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

Where it is running

• North Valley Eye Medical Group — Mission Hills, California, United States
• Clayton Eye Clinical Research — Morrow, Georgia, United States
• University of Michigan Kellogg Eye Center — Ann Arbor, Michigan, United States
• Rochester Ophthalmological Group — Rochester, New York, United States
• Abrams Eye Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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