Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) in Subjects With Dim Light Vision Disturbances

Completed · Phase 3 · Has a placebo group

Conditions studied: Dim Light Vision Disturbances

In brief

The objectives of this study are: * To evaluate the efficacy of Nyxol to improve mesopic low contrast visual acuity (mLCVA) in subjects with Dim Light Vision Disturbances (DLD) * To evaluate efficacy of Nyxol to improve visual performance * To evaluate the safety of Nyxol

Key facts

Study ID

NCT04638660

Run by

Ocuphire Pharma, Inc.

People needed

144

Starts

2020-12-30

Expected to finish

2022-05-19

Last updated by the study team

2025-10-14

Who can join

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

You may qualify if…

• Males or females ≥ 18 years of age
• Subject-reported DLD (likely subjects with a history of multifocal IOLs, post-laser-assisted in situ keratomileusis [LASIK], corneal scars, and keratoconus)
• Ability to comply with all protocol-mandated procedures independently and to attend all
• Otherwise healthy and well-controlled subjects
• Able and willing to give written consent to participate in this study
• Able to self-administer study medication
• PD ≥ 6 mm under mesopic conditions (prior to illumination) in at least one eye
• ≤ 20 (20/100 Snellen or worse) ETDRS letters in mLCVA score
• ≥10 ETDRS letters ( ≥2 lines) improvement in mLCVA in at least one eye during illumination of the contralateral eye with a BAT system on low setting

You may not qualify if…

• Ophthalmic:
• Prior history of dry eye diagnosis, taking prescription drops for dry eye, or taking artificial tear drops occasionally for dry eye
• Prior history of fluctuating vision
• Clinically significant ocular disease as deemed by the Investigator that might interfere with the study
• Known hypersensitivity to any topical alpha-adrenoceptor antagonists
• Known allergy or contraindication to any component of the vehicle formulation
• History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal
• Ocular trauma, ocular surgery (e.g., IOLs) or laser procedure (e.g., LASIK, photorefractive keratectomy [PRK]) within 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. Subjects must be symptom free for at least 7 days.
• History of diabetic retinopathy, diabetic macular edema, or dry or wet macular degeneration
• History of any traumatic (surgical or nonsurgical) or nontraumatic condition affecting the pupil or iris
• Unwilling or unable to discontinue use of contact lenses at screening until study completion, except for keratoconus subjects who may wear contacts up to 24 hours prior to their scheduled visits
• Systemic:
• Known hypersensitivity or contraindication to alpha- and/or beta-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 and during the conduct of the study
• 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 (50-110 beats per minute)
• Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHg

Where it is running

• Clinical Site 6 — Newport Beach, California, United States
• Clinical Site 1 — Petaluma, California, United States
• Clinical Site 3 — Jacksonville, Florida, United States
• Clinical Site 18 — Jacksonville, Florida, United States
• Clinical Site 13 — Pittsburg, Kansas, United States
• Clinical Site 20 — Edgewood, Kentucky, United States
• Clinical Site 14 — Louisville, Kentucky, United States
• Clinical Site 10 — Palisades Park, New Jersey, United States
• Clinical Site 8 — Pennington, New Jersey, United States
• Clinical Site 4 — Elizabeth City, North Carolina, United States
• Clinical Site 22 — High Point, North Carolina, United States
• Clinical Site 9 — High Point, North Carolina, United States
• Clinical Site 2 — Fargo, North Dakota, United States
• Clinical Test 15 — Warwick, Rhode Island, United States
• Clinical Site 11 — Memphis, Tennessee, United States
• Clinical Site 5 — San Antonio, Texas, United States
• Clinical Site 19 — Ogden, Utah, United States

Full record on ClinicalTrials.gov

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