Trial Outcomes & Findings for Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) in Subjects With Dim Light Vision Disturbances (NCT NCT04638660)
NCT ID: NCT04638660
Last Updated: 2025-10-14
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
144 participants
Primary outcome timeframe
8 days
Results posted on
2025-10-14
Participant Flow
Participant milestones
| Measure |
Phentolamine Ophthalmic Solution 0.75%
One drop in both eyes at or near bedtime (8PM to 10PM)
Phentolamine Ophthalmic Solution 0.75%: 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
|
Phentolamine Ophthalmic Solution Vehicle
One drop in both eyes at or near bedtime (8PM to 10PM)
Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical sterile ophthalmic solution
|
|---|---|---|
|
Overall Study
STARTED
|
71
|
73
|
|
Overall Study
COMPLETED
|
68
|
73
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Phentolamine Ophthalmic Solution 0.75%
One drop in both eyes at or near bedtime (8PM to 10PM)
Phentolamine Ophthalmic Solution 0.75%: 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
|
Phentolamine Ophthalmic Solution Vehicle
One drop in both eyes at or near bedtime (8PM to 10PM)
Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical sterile ophthalmic solution
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) in Subjects With Dim Light Vision Disturbances
Baseline characteristics by cohort
| Measure |
Phentolamine Ophthalmic Solution 0.75%
n=70 Participants
One drop in both eyes at or near bedtime (8PM to 10PM)
Phentolamine Ophthalmic Solution 0.75%: 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
|
Phentolamine Ophthalmic Solution Vehicle
n=73 Participants
One drop in both eyes at or near bedtime (8PM to 10PM)
Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical sterile ophthalmic solution
|
Total
n=143 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 14.14 • n=99 Participants
|
45.4 years
STANDARD_DEVIATION 14.40 • n=107 Participants
|
46.2 years
STANDARD_DEVIATION 14.24 • n=206 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
120 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
66 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
130 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
70 Participants
n=99 Participants
|
73 Participants
n=107 Participants
|
143 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 8 daysPercent 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
Outcome measures
| Measure |
Phentolamine Ophthalmic Solution 0.75%
n=70 Participants
One drop in both eyes at or near bedtime (8PM to 10PM)
Phentolamine Ophthalmic Solution 0.75%: 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
|
Phentolamine Ophthalmic Solution Vehicle
n=73 Participants
One drop in both eyes at or near bedtime (8PM to 10PM)
Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical sterile ophthalmic solution Phentolamine Ophthalmic Solution Vehicle
|
|---|---|---|
|
Percent of Subjects With 3 Lines mLCVA Improvement in Study Eye
|
9 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: up to 15 daysPopulation: miTT
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)
Outcome measures
| Measure |
Phentolamine Ophthalmic Solution 0.75%
n=70 Participants
One drop in both eyes at or near bedtime (8PM to 10PM)
Phentolamine Ophthalmic Solution 0.75%: 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
|
Phentolamine Ophthalmic Solution Vehicle
n=73 Participants
One drop in both eyes at or near bedtime (8PM to 10PM)
Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical sterile ophthalmic solution Phentolamine Ophthalmic Solution Vehicle
|
|---|---|---|
|
Percent of Subjects With mLCVA Improvement in Study Eye
Day 8 · >= 15 letters
|
9 Participants
|
2 Participants
|
|
Percent of Subjects With mLCVA Improvement in Study Eye
Day 8 · 10-14 letters
|
20 Participants
|
14 Participants
|
|
Percent of Subjects With mLCVA Improvement in Study Eye
Day 8 · 5-9 letters
|
22 Participants
|
29 Participants
|
|
Percent of Subjects With mLCVA Improvement in Study Eye
Day 8 · Less than 5
|
19 Participants
|
28 Participants
|
|
Percent of Subjects With mLCVA Improvement in Study Eye
Day 15 · >= 15 letters
|
14 Participants
|
2 Participants
|
|
Percent of Subjects With mLCVA Improvement in Study Eye
Day 15 · 10-14 letters
|
16 Participants
|
15 Participants
|
|
Percent of Subjects With mLCVA Improvement in Study Eye
Day 15 · 5-9 letters
|
28 Participants
|
39 Participants
|
|
Percent of Subjects With mLCVA Improvement in Study Eye
Day 15 · Less than 5
|
10 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: up to 15 daysPopulation: per-protocol(PP)
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
Outcome measures
| Measure |
Phentolamine Ophthalmic Solution 0.75%
n=68 Participants
One drop in both eyes at or near bedtime (8PM to 10PM)
Phentolamine Ophthalmic Solution 0.75%: 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
|
Phentolamine Ophthalmic Solution Vehicle
n=73 Participants
One drop in both eyes at or near bedtime (8PM to 10PM)
Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical sterile ophthalmic solution Phentolamine Ophthalmic Solution Vehicle
|
|---|---|---|
|
Percent of Subjects With Photopic Low Contrast Visual Acuity (pLCVA) and mHCVA Improvement in Study Eye
mHCVA Day 8 · 10-14 letters
|
5 Participants
|
3 Participants
|
|
Percent of Subjects With Photopic Low Contrast Visual Acuity (pLCVA) and mHCVA Improvement in Study Eye
pLVCA Day 8 · >= 15 letters
|
3 Participants
|
0 Participants
|
|
Percent of Subjects With Photopic Low Contrast Visual Acuity (pLCVA) and mHCVA Improvement in Study Eye
pLVCA Day 8 · 10-14 letters
|
12 Participants
|
9 Participants
|
|
Percent of Subjects With Photopic Low Contrast Visual Acuity (pLCVA) and mHCVA Improvement in Study Eye
pLVCA Day 8 · 5-9 letters
|
24 Participants
|
11 Participants
|
|
Percent of Subjects With Photopic Low Contrast Visual Acuity (pLCVA) and mHCVA Improvement in Study Eye
pLVCA Day 8 · Less than 5 letters
|
29 Participants
|
53 Participants
|
|
Percent of Subjects With Photopic Low Contrast Visual Acuity (pLCVA) and mHCVA Improvement in Study Eye
pLVCA Day 15 · >= 15 letters
|
7 Participants
|
1 Participants
|
|
Percent of Subjects With Photopic Low Contrast Visual Acuity (pLCVA) and mHCVA Improvement in Study Eye
pLVCA Day 15 · 10-14 letters
|
12 Participants
|
4 Participants
|
|
Percent of Subjects With Photopic Low Contrast Visual Acuity (pLCVA) and mHCVA Improvement in Study Eye
pLVCA Day 15 · 5-9 letters
|
22 Participants
|
20 Participants
|
|
Percent of Subjects With Photopic Low Contrast Visual Acuity (pLCVA) and mHCVA Improvement in Study Eye
pLVCA Day 15 · Less than 5 letters
|
23 Participants
|
46 Participants
|
|
Percent of Subjects With Photopic Low Contrast Visual Acuity (pLCVA) and mHCVA Improvement in Study Eye
mHCVA Day 8 · >= 15 letters
|
2 Participants
|
3 Participants
|
|
Percent of Subjects With Photopic Low Contrast Visual Acuity (pLCVA) and mHCVA Improvement in Study Eye
mHCVA Day 8 · 5-9 letters
|
16 Participants
|
11 Participants
|
|
Percent of Subjects With Photopic Low Contrast Visual Acuity (pLCVA) and mHCVA Improvement in Study Eye
mHCVA Day 8 · Less than 5 letters
|
45 Participants
|
56 Participants
|
|
Percent of Subjects With Photopic Low Contrast Visual Acuity (pLCVA) and mHCVA Improvement in Study Eye
mHCVA Day 15 · >= 15 letters
|
3 Participants
|
5 Participants
|
|
Percent of Subjects With Photopic Low Contrast Visual Acuity (pLCVA) and mHCVA Improvement in Study Eye
mHCVA Day 15 · 10-14 letters
|
8 Participants
|
1 Participants
|
|
Percent of Subjects With Photopic Low Contrast Visual Acuity (pLCVA) and mHCVA Improvement in Study Eye
mHCVA Day 15 · 5-9 letters
|
19 Participants
|
14 Participants
|
|
Percent of Subjects With Photopic Low Contrast Visual Acuity (pLCVA) and mHCVA Improvement in Study Eye
mHCVA Day 15 · Less than 5 letters
|
34 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: up to 15 daysChange from baseline in study eye mesopic PD
Outcome measures
| Measure |
Phentolamine Ophthalmic Solution 0.75%
n=70 Participants
One drop in both eyes at or near bedtime (8PM to 10PM)
Phentolamine Ophthalmic Solution 0.75%: 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
|
Phentolamine Ophthalmic Solution Vehicle
n=73 Participants
One drop in both eyes at or near bedtime (8PM to 10PM)
Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical sterile ophthalmic solution Phentolamine Ophthalmic Solution Vehicle
|
|---|---|---|
|
Change From Baseline in Study Eye Mesopic Pupil Diameter (PD)
8 Days, Change from Baseline
|
-1.081 millimeters
Standard Deviation 0.6931
|
-0.130 millimeters
Standard Deviation 0.5608
|
|
Change From Baseline in Study Eye Mesopic Pupil Diameter (PD)
15 Days, Change from Baseline
|
-1.083 millimeters
Standard Deviation 0.6556
|
-0.121 millimeters
Standard Deviation 0.4673
|
SECONDARY outcome
Timeframe: up to 15 daysPercent change from baseline in study eye mesopic PD
Outcome measures
| Measure |
Phentolamine Ophthalmic Solution 0.75%
n=68 Participants
One drop in both eyes at or near bedtime (8PM to 10PM)
Phentolamine Ophthalmic Solution 0.75%: 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
|
Phentolamine Ophthalmic Solution Vehicle
n=73 Participants
One drop in both eyes at or near bedtime (8PM to 10PM)
Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical sterile ophthalmic solution Phentolamine Ophthalmic Solution Vehicle
|
|---|---|---|
|
Percent Change From Baseline in Study Eye Mesopic Pupil Diameter (PD)
8 Days, Percent Change from Baseline
|
-17.98 percentage of change
Standard Deviation 11.542
|
-2.09 percentage of change
Standard Deviation 9.492
|
|
Percent Change From Baseline in Study Eye Mesopic Pupil Diameter (PD)
15 Days, Percent Change from Baseline
|
-18.06 percentage of change
Standard Deviation 11.418
|
-1.75 percentage of change
Standard Deviation 7.581
|
Adverse Events
Phentolamine Ophthalmic Solution 0.75%
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Phentolamine Ophthalmic Solution Vehicle
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Phentolamine Ophthalmic Solution 0.75%
n=71 participants at risk
One drop in both eyes at or near bedtime (8PM to 10PM)
Phentolamine Ophthalmic Solution 0.75%: 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
|
Phentolamine Ophthalmic Solution Vehicle
n=73 participants at risk
One drop in both eyes at or near bedtime (8PM to 10PM)
Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical sterile ophthalmic solution
|
|---|---|---|
|
General disorders
Instillation site pain
|
12.7%
9/71 • 15 days
|
0.00%
0/73 • 15 days
|
|
Nervous system disorders
Dysgeusia
|
11.3%
8/71 • 15 days
|
0.00%
0/73 • 15 days
|
|
Eye disorders
Conjunctival Hyperaemia
|
8.5%
6/71 • 15 days
|
2.7%
2/73 • 15 days
|
|
General disorders
Instillation site erythema
|
8.5%
6/71 • 15 days
|
0.00%
0/73 • 15 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60