Trial Outcomes & Findings for Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis (NCT NCT04620213)
NCT ID: NCT04620213
Last Updated: 2023-09-11
Results Overview
Percentage of subjects' study eyes returning to less than or equal to 0.2 mm from baseline pupil diameter
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
185 participants
Primary outcome timeframe
90 minutes
Results posted on
2023-09-11
Participant Flow
Participant milestones
| Measure |
Phentolamine Ophthalmic Solution 0.75%
2 drops in study eye and 1 drop in non-study eye, 1 hour post pharmacologically-induced mydriasis
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
2 drops in study eye and 1 drop in non-study eye, 1 hour post pharmacologically-induced mydriasis
Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical sterile ophthalmic solution
|
|---|---|---|
|
Overall Study
STARTED
|
94
|
91
|
|
Overall Study
COMPLETED
|
94
|
91
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis
Baseline characteristics by cohort
| Measure |
Phentolamine Ophthalmic Solution 0.75%
n=94 Participants
2 drops in study eye and 1 drop in non-study eye, 1 hour post pharmacologically-induced mydriasis
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=91 Participants
2 drops in study eye and 1 drop in non-study eye, 1 hour post pharmacologically-induced mydriasis
Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical sterile ophthalmic solution
|
Total
n=185 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.9 years
STANDARD_DEVIATION 14.04 • n=5 Participants
|
32.8 years
STANDARD_DEVIATION 13.55 • n=7 Participants
|
33.4 years
STANDARD_DEVIATION 13.77 • n=5 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
70 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Irides Type: Light, Dark
Light
|
45 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Irides Type: Light, Dark
Dark
|
49 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Mydriatic Agent
Phenylephrine
|
56 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Mydriatic Agent
Tropicamide
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Mydriatic Agent
Paremyd
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Baseline Pupil Diameter (Study Eye)
|
5.085 mm
STANDARD_DEVIATION 0.9295 • n=5 Participants
|
5.177 mm
STANDARD_DEVIATION 0.9678 • n=7 Participants
|
5.130 mm
STANDARD_DEVIATION 0.9471 • n=5 Participants
|
|
Baseline Accomodation (Study Eye)
|
10.47 D
STANDARD_DEVIATION 20.373 • n=5 Participants
|
8.25 D
STANDARD_DEVIATION 5.230 • n=7 Participants
|
9.38 D
STANDARD_DEVIATION 14.980 • n=5 Participants
|
|
Baseline BCDVA (Study Eye)
|
57.0 Letters
STANDARD_DEVIATION 4.10 • n=5 Participants
|
58.6 Letters
STANDARD_DEVIATION 4.49 • n=7 Participants
|
57.8 Letters
STANDARD_DEVIATION 4.36 • n=5 Participants
|
|
Baseline DCNVA
|
65.6 Letters
STANDARD_DEVIATION 10.63 • n=5 Participants
|
67.0 Letters
STANDARD_DEVIATION 9.74 • n=7 Participants
|
66.3 Letters
STANDARD_DEVIATION 10.20 • n=5 Participants
|
|
Baseline IOP (Study Eye)
|
15.3 mmHg
STANDARD_DEVIATION 2.78 • n=5 Participants
|
15.1 mmHg
STANDARD_DEVIATION 2.95 • n=7 Participants
|
15.2 mmHg
STANDARD_DEVIATION 2.85 • n=5 Participants
|
PRIMARY outcome
Timeframe: 90 minutesPercentage of subjects' study eyes returning to less than or equal to 0.2 mm from baseline pupil diameter
Outcome measures
| Measure |
Phentolamine Ophthalmic Solution 0.75%
n=94 Participants
2 drops in study eye and 1 drop in non-study eye, 1 hour post pharmacologically-induced mydriasis
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=91 Participants
2 drops in study eye and 1 drop in non-study eye, 1 hour post pharmacologically-induced mydriasis
Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical sterile ophthalmic solution
|
|---|---|---|
|
Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline
|
46 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: up to 24 hoursPercentage of subjects' study eyesreturning to less than or equal to 0.2 mm from baseline pupil diameter
Outcome measures
| Measure |
Phentolamine Ophthalmic Solution 0.75%
n=94 Participants
2 drops in study eye and 1 drop in non-study eye, 1 hour post pharmacologically-induced mydriasis
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=91 Participants
2 drops in study eye and 1 drop in non-study eye, 1 hour post pharmacologically-induced mydriasis
Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical sterile ophthalmic solution
|
|---|---|---|
|
Percent of Subjects' Study Eyes Pupil Diameter Returning to Baseline
90 minutes
|
46 Participants
|
6 Participants
|
|
Percent of Subjects' Study Eyes Pupil Diameter Returning to Baseline
2 hours
|
55 Participants
|
10 Participants
|
|
Percent of Subjects' Study Eyes Pupil Diameter Returning to Baseline
3 hours
|
75 Participants
|
16 Participants
|
|
Percent of Subjects' Study Eyes Pupil Diameter Returning to Baseline
4 hours
|
77 Participants
|
27 Participants
|
|
Percent of Subjects' Study Eyes Pupil Diameter Returning to Baseline
6 Hours
|
85 Participants
|
41 Participants
|
|
Percent of Subjects' Study Eyes Pupil Diameter Returning to Baseline
24 Hours
|
86 Participants
|
60 Participants
|
|
Percent of Subjects' Study Eyes Pupil Diameter Returning to Baseline
30 minutes
|
1 Participants
|
3 Participants
|
|
Percent of Subjects' Study Eyes Pupil Diameter Returning to Baseline
60 minutes
|
26 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: up to 24 hoursChange (mm) from maximum pharmacologically-induced mydriatic pupil diameter (0 minutes)
Outcome measures
| Measure |
Phentolamine Ophthalmic Solution 0.75%
n=94 Participants
2 drops in study eye and 1 drop in non-study eye, 1 hour post pharmacologically-induced mydriasis
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=91 Participants
2 drops in study eye and 1 drop in non-study eye, 1 hour post pharmacologically-induced mydriasis
Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical sterile ophthalmic solution
|
|---|---|---|
|
Pupil Diameter (Change From Max)
Baseline (-1 Hour)
|
5.085 millimeters
Standard Deviation 0.9295
|
5.177 millimeters
Standard Deviation 0.9678
|
|
Pupil Diameter (Change From Max)
0 minutes
|
7.207 millimeters
Standard Deviation 1.024
|
7.197 millimeters
Standard Deviation 1.1717
|
|
Pupil Diameter (Change From Max)
30 minutes
|
0.025 millimeters
Standard Deviation 0.4780
|
0.075 millimeters
Standard Deviation 0.4266
|
|
Pupil Diameter (Change From Max)
60 minutes
|
-1.308 millimeters
Standard Deviation 0.8705
|
-0.122 millimeters
Standard Deviation 0.4055
|
|
Pupil Diameter (Change From Max)
90 minutes
|
-2.192 millimeters
Standard Deviation 1.0117
|
-0.329 millimeters
Standard Deviation 0.4653
|
|
Pupil Diameter (Change From Max)
2 hours
|
-2.429 millimeters
Standard Deviation 0.9837
|
-0.518 millimeters
Standard Deviation 0.5930
|
|
Pupil Diameter (Change From Max)
3 hours
|
-2.828 millimeters
Standard Deviation 0.9817
|
-0.806 millimeters
Standard Deviation 0.6253
|
|
Pupil Diameter (Change From Max)
4 hours
|
-2.991 millimeters
Standard Deviation 1.0793
|
-1.159 millimeters
Standard Deviation 0.8223
|
|
Pupil Diameter (Change From Max)
6 hours
|
-3.338 millimeters
Standard Deviation 1.0797
|
-1.634 millimeters
Standard Deviation 1.0595
|
|
Pupil Diameter (Change From Max)
24 Hours
|
-3.375 millimeters
Standard Deviation 1.2302
|
-2.173 millimeters
Standard Deviation 1.3868
|
SECONDARY outcome
Timeframe: up to 6 hoursPopulation: Subjects within each overall treatment group were randomized to receive one of 3 mydriatic agents (3;1;1); therefore the number of subjects in the the subgroups do not match the overall number analyzed.
Percentage of subjects with unchanged accommodation from baseline (-1 hour)
Outcome measures
| Measure |
Phentolamine Ophthalmic Solution 0.75%
n=94 Participants
2 drops in study eye and 1 drop in non-study eye, 1 hour post pharmacologically-induced mydriasis
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=91 Participants
2 drops in study eye and 1 drop in non-study eye, 1 hour post pharmacologically-induced mydriasis
Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical sterile ophthalmic solution
|
|---|---|---|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Phenylephrine, 0 minutes · Changed from Baseline
|
26 Participants
|
18 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Phenylephrine, 60 minutes · Unchanged from Baseline
|
29 Participants
|
39 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Phenylephrine, 90 minutes · Unchanged from Baseline
|
38 Participants
|
40 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Phenylephrine, 90 minutes · Changed from Baseline
|
18 Participants
|
15 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Phenylephrine, 2 hours · Unchanged from Baseline
|
40 Participants
|
42 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Phenylephrine, 2 hours · Changed from Baseline
|
16 Participants
|
13 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Phenylephrine, 4 hours · Unchanged from Baseline
|
39 Participants
|
42 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Phenylephrine, 4 hours · Changed from Baseline
|
17 Participants
|
13 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Phenylephrine, 6 hours · Unchanged from Baseline
|
43 Participants
|
48 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Phenylephrine, 6 hours · Changed from Baseline
|
13 Participants
|
7 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Tropicamide, 0 Minutes · Unchanged from Baseline
|
2 Participants
|
2 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Tropicamide, 0 Minutes · Changed from Baseline
|
17 Participants
|
16 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Tropicamide, 60 Minutes · Unchanged from Baseline
|
6 Participants
|
5 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Tropicamide, 60 Minutes · Changed from Baseline
|
13 Participants
|
13 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Tropicamide, 90 Minutes · Unchanged from Baseline
|
10 Participants
|
5 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Tropicamide, 2 Hours · Changed from Baseline
|
7 Participants
|
12 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Tropicamide, 3 Hours · Unchanged from Baseline
|
13 Participants
|
8 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Tropicamide, 3 Hours · Changed from Baseline
|
6 Participants
|
10 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Tropicamide, 4 Hours · Unchanged from Baseline
|
14 Participants
|
10 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Tropicamide, 4 Hours · Changed from Baseline
|
5 Participants
|
8 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Tropicamide, 6 Hours · Unchanged from Baseline
|
14 Participants
|
12 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Tropicamide, 6 Hours · Changed from Baseline
|
5 Participants
|
6 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Paremyd, 0 Minutes · Unchanged from Baseline
|
2 Participants
|
3 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Paremyd, 0 Minutes · Changed from Baseline
|
17 Participants
|
15 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Paremyd, 60 Minutes · Unchanged from Baseline
|
6 Participants
|
6 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Paremyd, 60 Minutes · Changed from Baseline
|
13 Participants
|
12 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Paremyd, 90 Minutes · Unchanged from Baseline
|
7 Participants
|
7 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Paremyd, 90 Minutes · Changed from Baseline
|
12 Participants
|
11 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Paremyd, 2 Hours · Unchanged from Baseline
|
9 Participants
|
7 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Paremyd, 2 Hours · Changed from Baseline
|
10 Participants
|
11 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Paremyd, 3 Hours · Unchanged from Baseline
|
11 Participants
|
10 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Paremyd, 3 Hours · Changed from Baseline
|
8 Participants
|
8 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Paremyd, 4 Hours · Unchanged from Baseline
|
14 Participants
|
11 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Paremyd, 4 Hours · Changed from Baseline
|
5 Participants
|
7 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Paremyd, 6 Hours · Unchanged from Baseline
|
14 Participants
|
11 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Paremyd, 6 Hours · Changed from Baseline
|
5 Participants
|
7 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Tropicamide or Paremyd, 0 Minutes · Unchanged from Baseline
|
4 Participants
|
5 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Tropicamide or Paremyd, 0 Minutes · Changed from Baseline
|
34 Participants
|
31 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Tropicamide or Paremyd, 60 Minutes · Unchanged from Baseline
|
12 Participants
|
11 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Tropicamide or Paremyd, 60 Minutes · Changed from Baseline
|
26 Participants
|
25 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Tropicamide or Paremyd, 90 Minutes · Unchanged from Baseline
|
17 Participants
|
12 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Tropicamide or Paremyd, 90 Minutes · Changed from Baseline
|
21 Participants
|
24 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Tropicamide or Paremyd, 2 Hours · Unchanged from Baseline
|
21 Participants
|
13 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Tropicamide or Paremyd, 2 Hours · Changed from Baseline
|
17 Participants
|
23 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Tropicamide or Paremyd, 3 Hours · Unchanged from Baseline
|
24 Participants
|
18 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Tropicamide or Paremyd, 3 Hours · Changed from Baseline
|
14 Participants
|
18 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Tropicamide or Paremyd, 4 Hours · Unchanged from Baseline
|
28 Participants
|
21 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Tropicamide or Paremyd, 4 Hours · Changed from Baseline
|
10 Participants
|
15 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Tropicamide or Paremyd, 6 Hours · Unchanged from Baseline
|
28 Participants
|
23 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Tropicamide or Paremyd, 6 Hours · Changed from Baseline
|
10 Participants
|
13 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Phenylephrine, 0 minutes · Unchanged from Baseline
|
30 Participants
|
37 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Phenylephrine, 60 minutes · Changed from Baseline
|
27 Participants
|
16 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Phenylephrine, 3 hours · Unchanged from Baseline
|
38 Participants
|
45 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Phenylephrine, 3 hours · Changed from Baseline
|
18 Participants
|
10 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Tropicamide, 90 Minutes · Changed from Baseline
|
9 Participants
|
13 Participants
|
|
Percent of Subjects With Unchanged Accommodation From Baseline
Tropicamide, 2 Hours · Unchanged from Baseline
|
12 Participants
|
6 Participants
|
Adverse Events
Phentolamine Ophthalmic Solution 0.75%
Serious events: 0 serious events
Other events: 48 other events
Deaths: 0 deaths
Phentolamine Ophthalmic Solution Vehicle
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Phentolamine Ophthalmic Solution 0.75%
n=94 participants at risk
2 drops in study eye and 1 drop in non-study eye, 1 hour post pharmacologically-induced mydriasis
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=91 participants at risk
2 drops in study eye and 1 drop in non-study eye, 1 hour post pharmacologically-induced mydriasis
Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical sterile ophthalmic solution
|
|---|---|---|
|
General disorders
Instillation site discomfort
|
38.3%
36/94 • 2 days
|
8.8%
8/91 • 2 days
|
|
Eye disorders
Conjunctival Hyperaemia
|
12.8%
12/94 • 2 days
|
0.00%
0/91 • 2 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60