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
Placebo-controlled, double-masked, multiple-dose, Phase 3 study in approximately 160 randomized subjects with DLD (approximately 136 that are evaluable for efficacy), evaluating safety and efficacy of Nyxol in subjects with DLD following administration of Nyxol once daily (QD) at or near bedtime (at 8PM to 10PM) in both eyes (OU) for 14 days. Following the successful completion of screening, each subject will be stratified by iris color (light/dark irides) and will then be randomized to treatment (masked) 1:1, Nyxol or placebo (vehicle). Treatment (Nyxol or placebo) will be administered in both eyes (OU) by the subjects at or near bedtime each day. At the first visit subjects will be screened for study eligibility. Treatment visits will occur 2 times: Day 8 (+1 day)/Visit 2 and Day 15 (+1 day)/Visit 3. mLCVA evaluations shall be performed on each of these days. A follow-up visit (Visit 4) phone call will occur 1 to 3 days after Visit 3. At select sites OPD Scan measurements will be made using wavefront abhermettry.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
144
0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
Topical sterile ophthalmic solution
Clinical Site 6
Newport Beach, California, United States
Clinical Site 1
Petaluma, California, United States
Percent of Subjects With 3 Lines mLCVA Improvement in Study Eye
Percent of subjects with ≥ 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (≥3 lines) of improvement in the study eye compared to baseline in monocular mLCVA at Day 8
Time frame: 8 days
Percent of Subjects With mLCVA Improvement in Study Eye
Percent of subjects with ≥ 5, ≥ 10, and ≥ 15 ETDRS letters (≥ 1, ≥ 2, and ≥ 3 lines, respectively) improvement compared to baseline in mLCVA at Day 8 (excluding the primary endpoint)
Time frame: up to 15 days
Percent of Subjects With Photopic Low Contrast Visual Acuity (pLCVA) and mHCVA Improvement in Study Eye
Percent of subjects with ≥ 5, ≥ 10, and ≥ 15 ETDRS letters (≥ 1, ≥ 2, and ≥ 3 lines, respectively) improvement compared to baseline in pLCVA and mHCVA at Day 8 and Day 15
Time frame: up to 15 days
Change From Baseline in Study Eye Mesopic Pupil Diameter (PD)
Change from baseline in study eye mesopic PD
Time frame: up to 15 days
Percent Change From Baseline in Study Eye Mesopic Pupil Diameter (PD)
Percent change from baseline in study eye mesopic PD
Time frame: up to 15 days
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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
...and 7 more locations