Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) in Subjects With Dim Light Vision Disturbances
Condition: Dim Light Vision Disturbances
MeSH terms: Vision Disorders
Intervention: Phentolamine Ophthalmic Solution 0.75%; Phentolamine Ophthalmic Solution Vehicle (Placebo)
Intervention description: 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist; Topical sterile ophthalmic solution
Intervention MeSH terms: Phentolamine; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All subjects will be randomized into the study in a 1:1 ratio to one of the treatment arms (Nyxol or placebo), with a stratification by light/dark irides.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 144.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Nyxol, Night Vision Disturbances, Glare, Halos, Starbursts

Summary:

      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
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or females ≥ 18 years of age

          2. Subject-reported DLD (likely subjects with a history of multifocal IOLs,
             post-laser-assisted in situ keratomileusis [LASIK], corneal scars, and keratoconus)

          3. Ability to comply with all protocol-mandated procedures independently and to attend
             all

          4. Otherwise healthy and well-controlled subjects

          5. Able and willing to give written consent to participate in this study

          6. Able to self-administer study medication

          7. PD ≥ 6 mm under mesopic conditions (prior to illumination) in at least one eye

          8. ≤ 20 (20/100 Snellen or worse) ETDRS letters in mLCVA score

        Exclusion Criteria:

        Ophthalmic:

          1. Prior history of dry eye diagnosis, taking prescription drops for dry eye, or taking
             artificial tear drops occasionally for dry eye

          2. Prior history of fluctuating vision

          3. Clinically significant ocular disease as deemed by the Investigator that might
             interfere with the study

          4. Known hypersensitivity to any topical alpha-adrenoceptor antagonists

          5. Known allergy or contraindication to any component of the vehicle formulation

          6. History of cauterization of the punctum or punctal plug (silicone or collagen)
             insertion or removal

          7. Ocular trauma, ocular surgery (e.g., IOLs) or laser procedure (e.g., LASIK,
             photorefractive keratectomy [PRK]) within 6 months prior to screening

          8. Use of any topical prescription or over-the-counter (OTC) ophthalmic medications of
             any kind within 7 days of screening

          9. Recent or current evidence of ocular infection or inflammation in either eye. Subjects
             must be symptom free for at least 7 days.

         10. History of diabetic retinopathy, diabetic macular edema, or dry or wet macular
             degeneration

         11. History of any traumatic (surgical or nonsurgical) or nontraumatic condition affecting
             the pupil or iris

         12. 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:

          1. Known hypersensitivity or contraindication to alpha- and/or beta-adrenoceptor
             antagonists

          2. Clinically significant systemic disease that might interfere with the study

          3. 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

          4. Participation in any investigational study within 30 days prior to screening and
             during the conduct of the study

          5. Females of childbearing potential who are pregnant, nursing, planning a pregnancy, or
             not using a medically acceptable form of birth control

          6. Resting HR outside the specified range (50-110 beats per minute)

          7. Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHg