Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis (MIRA-3)

Completed · Phase 3

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 * To evaluate the systemic exposure of Nyxol on pharmacokinetic (PK) sampling

Key facts

Study ID

NCT05134974

Run by

Ocuphire Pharma, Inc.

People needed

368

Starts

2021-11-18

Expected to finish

2022-03-29

Last updated by the study team

2023-08-29

Who can join

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

You may qualify if…

• Males or females ≥ 12 years of age
• Ability to comply with all protocol-mandated procedures independently and to attend all scheduled office visits

You may not qualify if…

• Clinically significant ocular disease as deemed by the Investigator (eg, glaucoma, corneal edema, uveitis, severe keratoconjunctivitis sicca) 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, with the exception of lid scrubs with OTC products (eg, OCuSOFT® lid scrub, SteriLid®, baby shampoo, etc.)
• Recent or current evidence of ocular infection or inflammation in either eye (such as current evidence of clinically significant blepharitis, conjunctivitis, or keratitis). Subjects must be symptom-free for at least 7 days prior to screening
• Closed or very narrow-angle that in the Investigator's opinion is potentially occludable if the subject's pupil is dilated
• Prior participation in a study involving the use of Nyxol for the reversal of mydriasis
• Known hypersensitivity or contraindication to α- and/or β-adrenoceptor antagonists
• Clinically significant systemic disease (eg, uncontrolled diabetes, myasthenia gravis, cancer, hepatic, renal, endocrine, or cardiovascular disorders) that might interfere with the study
• Participation in any investigational study within 30 days prior to screening
• Resting heart rate (HR) outside the normal range (50-110 beats per minute) at the Screening Visit.
• Hypertension with resting diastolic blood pressure (BP)>105 mmHg or systolic BP > 160 mmHg at the Screening Visit.

Where it is running

• Clinical Site 10 — Newport Beach, California, United States
• Clinical Site 12 — Westminster, California, United States
• Clinical Site 9 — Delray Beach, Florida, United States
• Clinical Site 8 — Longwood, Florida, United States
• Clinical Site 6 — Morrow, Georgia, United States
• Clinical Site 1 — Roswell, Georgia, United States
• Clinical Site 13 — Lake Villa, Illinois, United States
• Clinical Site 5 — Pittsburg, Kansas, United States
• Clinical Site 2 — Bloomington, Minnesota, United States
• Clinical Site 15 — Garner, North Carolina, United States
• Clinical Site 4 — Athens, Ohio, United States
• Clinical Site 14 — Shrewsbury, Pennsylvania, United States
• Clinical Site 7 — Warwick, Rhode Island, United States
• Clinical Site 11 — Sioux Falls, South Dakota, United States
• Clinical Site 3 — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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