Trial Outcomes & Findings for Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis in Pediatric Subjects (NCT NCT05223478)
NCT ID: NCT05223478
Last Updated: 2023-09-05
Results Overview
Study Eye Change from Baseline (-1 Hour) Conjunctival Hyperemia Grading; Cornea and Contact Lens Research Unit (CCLRU scale) Grades range from 0 to 3, with 3 being considered the most severe.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
23 participants
Primary outcome timeframe
0 Minutes, 90 Minutes, 3 Hours, 24 Hours
Results posted on
2023-09-05
Participant Flow
Participant milestones
| Measure |
Phentolamine Ophthalmic Solution 0.75%
One drop of study medication in each eye.
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 of study medication in each eye.
Phentolamine Ophthalmic Solution Vehicle: Phentolamine Ophthalmic Solution Vehicle
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
12
|
|
Overall Study
COMPLETED
|
11
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis in Pediatric Subjects
Baseline characteristics by cohort
| Measure |
Phentolamine Ophthalmic Solution 0.75%
n=11 Participants
One drop of study medication in each eye.
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=12 Participants
One drop of study medication in each eye.
Phentolamine Ophthalmic Solution Vehicle: Phentolamine Ophthalmic Solution Vehicle
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
6 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
|
Age, Categorical
<=18 years
|
11 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
23 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Continuous
|
6.9 years
STANDARD_DEVIATION 2.74 • n=39 Participants
|
5.8 years
STANDARD_DEVIATION 2.66 • n=41 Participants
|
6.3 years
STANDARD_DEVIATION 2.69 • n=35 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
20 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=39 Participants
|
12 participants
n=41 Participants
|
23 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 0 Minutes, 90 Minutes, 3 Hours, 24 HoursStudy Eye Change from Baseline (-1 Hour) Conjunctival Hyperemia Grading; Cornea and Contact Lens Research Unit (CCLRU scale) Grades range from 0 to 3, with 3 being considered the most severe.
Outcome measures
| Measure |
Phentolamine Ophthalmic Solution 0.75%
n=11 Participants
One drop of study medication in each eye.
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=12 Participants
One drop of study medication in each eye.
Phentolamine Ophthalmic Solution Vehicle: Phentolamine Ophthalmic Solution Vehicle
|
|---|---|---|
|
Safety Measurements
0 Minutes
|
0.3 score on a scale
Standard Deviation 0.65
|
-0.2 score on a scale
Standard Deviation 0.58
|
|
Safety Measurements
90 Minutes
|
1.6 score on a scale
Standard Deviation 0.50
|
0.0 score on a scale
Standard Deviation 0.43
|
|
Safety Measurements
3 Hours
|
1.1 score on a scale
Standard Deviation 0.54
|
-0.1 score on a scale
Standard Deviation 0.29
|
|
Safety Measurements
24 Hours
|
0.1 score on a scale
Standard Deviation 0.30
|
-0.2 score on a scale
Standard Deviation 0.58
|
PRIMARY outcome
Timeframe: 3 Hours, 24 HoursChange from Screening Heart Rate
Outcome measures
| Measure |
Phentolamine Ophthalmic Solution 0.75%
n=11 Participants
One drop of study medication in each eye.
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=12 Participants
One drop of study medication in each eye.
Phentolamine Ophthalmic Solution Vehicle: Phentolamine Ophthalmic Solution Vehicle
|
|---|---|---|
|
Vital Signs
3 Hours
|
-1.1 beats per minute
Standard Deviation 7.92
|
-2.0 beats per minute
Standard Deviation 14.24
|
|
Vital Signs
24 Hours
|
-2.5 beats per minute
Standard Deviation 10.10
|
-3.5 beats per minute
Standard Deviation 12.69
|
PRIMARY outcome
Timeframe: 3 Hours, 24 HoursChange from Screening Blood Pressure (Systolic)
Outcome measures
| Measure |
Phentolamine Ophthalmic Solution 0.75%
n=11 Participants
One drop of study medication in each eye.
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=12 Participants
One drop of study medication in each eye.
Phentolamine Ophthalmic Solution Vehicle: Phentolamine Ophthalmic Solution Vehicle
|
|---|---|---|
|
Vital Signs
3 Hours
|
-4.6 mmHg
Standard Deviation 8.91
|
-0.8 mmHg
Standard Deviation 12.39
|
|
Vital Signs
24 Hours
|
-2.8 mmHg
Standard Deviation 7.48
|
-5.8 mmHg
Standard Deviation 6.98
|
PRIMARY outcome
Timeframe: 0 Minutes, 3 Hours, 24 HoursStudy Eye Change from Baseline (-1 Hour) in Best Corrected Distance Visual Acuity
Outcome measures
| Measure |
Phentolamine Ophthalmic Solution 0.75%
n=11 Participants
One drop of study medication in each eye.
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=12 Participants
One drop of study medication in each eye.
Phentolamine Ophthalmic Solution Vehicle: Phentolamine Ophthalmic Solution Vehicle
|
|---|---|---|
|
Safety Measurement
24 Hours
|
1.5 letters
Standard Deviation 1.97
|
0.7 letters
Standard Deviation 1.15
|
|
Safety Measurement
0 Minutes
|
-1.2 letters
Standard Deviation 1.66
|
-0.3 letters
Standard Deviation 1.23
|
|
Safety Measurement
3 Hours
|
1.2 letters
Standard Deviation 1.89
|
0.1 letters
Standard Deviation 0.67
|
PRIMARY outcome
Timeframe: 3 Hours, 24 HoursOutcome measures
| Measure |
Phentolamine Ophthalmic Solution 0.75%
n=11 Participants
One drop of study medication in each eye.
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=12 Participants
One drop of study medication in each eye.
Phentolamine Ophthalmic Solution Vehicle: Phentolamine Ophthalmic Solution Vehicle
|
|---|---|---|
|
Change From Screening Blood Pressure (Diastolic)
3 Hours
|
-2.4 mmHg
Standard Deviation 9.72
|
1.0 mmHg
Standard Deviation 15.68
|
|
Change From Screening Blood Pressure (Diastolic)
24 Hours
|
-1.1 mmHg
Standard Deviation 11.63
|
-3.8 mmHg
Standard Deviation 7.96
|
SECONDARY outcome
Timeframe: 90 Minutes, 3 Hours, and 24 HoursPercentage of Subjects Returning to ≤ 0.2 mm from Baseline (-1 hour) Pupil Diameter (Study Eye)
Outcome measures
| Measure |
Phentolamine Ophthalmic Solution 0.75%
n=11 Participants
One drop of study medication in each eye.
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=12 Participants
One drop of study medication in each eye.
Phentolamine Ophthalmic Solution Vehicle: Phentolamine Ophthalmic Solution Vehicle
|
|---|---|---|
|
Efficacy Measurement: Pupil Diameter
90 Minutes
|
7 Participants
|
3 Participants
|
|
Efficacy Measurement: Pupil Diameter
3 Hours
|
9 Participants
|
4 Participants
|
|
Efficacy Measurement: Pupil Diameter
24 Hours
|
10 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 90 Minutes, 3 Hours, and 24 HoursChange (in mm) in Pupil Diameter from Max Pupil Dilation (0 minutes) (Study Eye)
Outcome measures
| Measure |
Phentolamine Ophthalmic Solution 0.75%
n=11 Participants
One drop of study medication in each eye.
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=12 Participants
One drop of study medication in each eye.
Phentolamine Ophthalmic Solution Vehicle: Phentolamine Ophthalmic Solution Vehicle
|
|---|---|---|
|
Efficacy Measurement: Pupil Diameter
90 Minutes
|
-1.475 millimeters
Standard Deviation 0.7188
|
-0.378 millimeters
Standard Deviation 0.4473
|
|
Efficacy Measurement: Pupil Diameter
3 Hours
|
-2.031 millimeters
Standard Deviation 0.6919
|
-0.723 millimeters
Standard Deviation 0.6470
|
|
Efficacy Measurement: Pupil Diameter
24 Hours
|
-2.005 millimeters
Standard Deviation 1.2841
|
-1.44 millimeters
Standard Deviation 1.2891
|
SECONDARY outcome
Timeframe: Up to 24 HoursTime (Hours) to Return to ≤ 0.2 mm from Baseline (-1 Hour) Pupil Diameter (Time-savings Analysis) (Study Eye)
Outcome measures
| Measure |
Phentolamine Ophthalmic Solution 0.75%
n=11 Participants
One drop of study medication in each eye.
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=12 Participants
One drop of study medication in each eye.
Phentolamine Ophthalmic Solution Vehicle: Phentolamine Ophthalmic Solution Vehicle
|
|---|---|---|
|
Efficacy Measurement: Pupil Diameter
|
2.95 hours
Standard Deviation 2.564
|
5.54 hours
Standard Deviation 3.078
|
Adverse Events
Phentolamine Ophthalmic Solution 0.75%
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phentolamine Ophthalmic Solution Vehicle
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60