Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis

Completed · Phase 3 · Has a placebo group

Conditions studied: Mydriasis, Dilation

In brief

The objectives of this study are: * To evaluate the efficacy of Nyxol to expedite the reversal of pharmacologically-induced mydriasis across multiple mydriatic agents with an emphasis on phenylephrine * To evaluate the efficacy of Nyxol to return subjects to baseline accommodation after worsening (with cycloplegic agents tropicamide and Paremyd) * To evaluate the safety of Nyxol * To evaluate any additional benefits of the reversal of pharmacologically-induced mydriasis

Key facts

Study ID

NCT04620213

Run by

Ocuphire Pharma, Inc.

People needed

185

Starts

2020-11-18

Expected to finish

2021-03-15

Last updated by the study team

2023-09-11

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Males or females ≥ 12 years of age
• Otherwise healthy and well controlled subjects

You may not qualify if…

• Ophthalmic (in either eye):
• Clinically significant ocular disease as deemed by the Investigator that might interfere with the study
• Unwilling or unable to discontinue use of contact lenses at screening until study completion
• Unwilling or unable to suspend use of topical medication at screening until study completion
• Ocular trauma, ocular surgery or non-refractive laser treatment within the 6 months prior to screening
• Use of any topical prescription or over-the-counter (OTC) ophthalmic medications of any kind within 7 days of screening
• Recent or current evidence of ocular infection or inflammation in either eye
• History of diabetic retinopathy or diabetic macular edema
• Closed or very narrow angles that in the Investigator's opinion are potentially occludable if the subject's pupil is dilated
• History of any traumatic (surgical or nonsurgical) or non-traumatic condition affecting the pupil or iris
• Known allergy or contraindication to any component of the mydriatic agents or the vehicle formulation
• History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal
• Systemic:
• Known hypersensitivity or contraindication to α- and/or β adrenoceptor antagonists.
• Clinically significant systemic disease that might interfere with the study
• 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 normal range (50-110 beats per minute)
• Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHg

Where it is running

• Clinical Site 11 — Newport Beach, California, United States
• Clinical Site 10 — San Diego, California, United States
• Clinical Site 9 — Longwood, Florida, United States
• Clinical Site 6 — Orlando, Florida, United States
• Clinical Site 2 — Roswell, Georgia, United States
• Clinical Site 7 — Pittsburg, Kansas, United States
• Clinical Site 3 — Shawnee Mission, Kansas, United States
• Clinical Site 5 — Athens, Ohio, United States
• Clinical Site 12 — Cincinnati, Ohio, United States
• Clinical Site 1 — Cleveland, Ohio, United States
• Clinical Site 8 — Warwick, Rhode Island, United States
• Clinical Site 4 — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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