Trial Outcomes & Findings for Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis (MIRA-3) (NCT NCT05134974)

NCT ID: NCT05134974

Last Updated: 2023-08-29

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: 368 participants
• Primary outcome timeframe: 90 minutes
• Results posted on: 2023-08-29

Participant Flow

Participant milestones

Measure	Phentolamine Ophthalmic Solution Vehicle 2 drops in study eye and 1 drop in non-study eye, administered 1 hour post pharmacologically-induced mydriasis Phentolamine Ophthalmic Solution Vehicle: Phentolamine Ophthalmic Solution Vehicle	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
Overall Study STARTED	124	244
Overall Study COMPLETED	124	244
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 (MIRA-3)

Baseline characteristics by cohort

Measure	Phentolamine Ophthalmic Solution 0.75% n=244 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=124 Participants 2 drops in study eye and 1 drop in non-study eye, 1 hour post pharmacologically-induced mydriasis Phentolamine Ophthalmic Solution Vehicle: Phentolamine Ophthalmic Solution Vehicle	Total n=368 Participants Total of all reporting groups
Age, Continuous	34.2 years STANDARD_DEVIATION 15.61 • n=93 Participants	35.6 years STANDARD_DEVIATION 17.58 • n=4 Participants	34.6 years STANDARD_DEVIATION 16.29 • n=27 Participants
Sex: Female, Male Female	152 Participants n=93 Participants	65 Participants n=4 Participants	217 Participants n=27 Participants
Sex: Female, Male Male	92 Participants n=93 Participants	59 Participants n=4 Participants	151 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	21 Participants n=93 Participants	9 Participants n=4 Participants	30 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	223 Participants n=93 Participants	115 Participants n=4 Participants	338 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	22 Participants n=93 Participants	9 Participants n=4 Participants	31 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 Participants n=93 Participants	0 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) Black or African American	38 Participants n=93 Participants	21 Participants n=4 Participants	59 Participants n=27 Participants
Race (NIH/OMB) White	179 Participants n=93 Participants	93 Participants n=4 Participants	272 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Region of Enrollment United States	244 participants n=93 Participants	124 participants n=4 Participants	368 participants n=27 Participants

PRIMARY outcome

Timeframe: 90 minutes

Percentage 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=244 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=124 Participants 2 drops in study eye and 1 drop in non-study eye, 1 hour post pharmacologically-induced mydriasis Phentolamine Ophthalmic Solution Vehicle: Phentolamine Ophthalmic Solution Vehicle
Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline Returning to <= 0.2mm of Baseline	142 Participants	7 Participants
Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline Not returning to <= 0.2mm of Baseline	102 Participants	117 Participants

SECONDARY outcome

Timeframe: 30 minutes to 24 hours

Percentage 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=244 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=124 Participants 2 drops in study eye and 1 drop in non-study eye, 1 hour post pharmacologically-induced mydriasis Phentolamine Ophthalmic Solution Vehicle: Phentolamine Ophthalmic Solution Vehicle
Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline 60 minutes · Returning to <=0.2 mm of Baseline	103 Participants	3 Participants
Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline 30 minutes · Returning to <=0.2 mm of Baseline	10 Participants	5 Participants
Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline 30 minutes · Not returning to <=0.2 mm of Baseline	234 Participants	119 Participants
Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline 60 minutes · Not returning to <=0.2 mm of Baseline	141 Participants	121 Participants
Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline 90 minutes · Returning to <=0.2 mm of Baseline	142 Participants	7 Participants
Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline 90 minutes · Not returning to <=0.2 mm of Baseline	102 Participants	117 Participants
Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline 2 Hours · Returning to <=0.2 mm of Baseline	162 Participants	9 Participants
Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline 2 Hours · Not returning to <=0.2 mm of Baseline	82 Participants	115 Participants
Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline 3 Hours · Returning to <=0.2 mm of Baseline	193 Participants	17 Participants
Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline 3 Hours · Not returning to <=0.2 mm of Baseline	51 Participants	107 Participants
Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline 4 Hours · Returning to <=0.2 mm of Baseline	210 Participants	21 Participants
Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline 4 Hours · Not returning to <=0.2 mm of Baseline	34 Participants	103 Participants
Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline 6 Hours · Returning to <=0.2 mm of Baseline	221 Participants	44 Participants
Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline 6 Hours · Not returning to <=0.2 mm of Baseline	23 Participants	80 Participants
Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline 24 Hours · Returning to <=0.2 mm of Baseline	218 Participants	89 Participants
Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline 24 Hours · Not returning to <=0.2 mm of Baseline	26 Participants	35 Participants

SECONDARY outcome

Timeframe: 30 minutes to 24 hours

Change (mm) from maximum pharmacologically-induced mydriatic pupil diameter (0 minutes)

Outcome measures

Measure	Phentolamine Ophthalmic Solution 0.75% n=244 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=124 Participants 2 drops in study eye and 1 drop in non-study eye, 1 hour post pharmacologically-induced mydriasis Phentolamine Ophthalmic Solution Vehicle: Phentolamine Ophthalmic Solution Vehicle
Pupil Diameter (Change From Max) 30 Minutes	-0.109 millimeters Standard Deviation 0.7104	0.092 millimeters Standard Deviation 0.5335
Pupil Diameter (Change From Max) 60 Minutes	-1.457 millimeters Standard Deviation 1.0825	-0.059 millimeters Standard Deviation 0.5775
Pupil Diameter (Change From Max) 90 Minutes	-2.157 millimeters Standard Deviation 1.1911	-0.284 millimeters Standard Deviation 0.5852
Pupil Diameter (Change From Max) 2 Hours	-2.478 millimeters Standard Deviation 1.1453	-0.488 millimeters Standard Deviation 0.6807
Pupil Diameter (Change From Max) 3 Hours	-2.917 millimeters Standard Deviation 1.1721	-0.987 millimeters Standard Deviation 0.7932
Pupil Diameter (Change From Max) 4 Hours	-3.078 millimeters Standard Deviation 1.1578	-1.261 millimeters Standard Deviation 0.8615
Pupil Diameter (Change From Max) 6 Hours	-3.267 millimeters Standard Deviation 1.2743	-1.755 millimeters Standard Deviation 1.0205
Pupil Diameter (Change From Max) 24 Hours	-3.134 millimeters Standard Deviation 1.3607	-2.313 millimeters Standard Deviation 1.3607

SECONDARY outcome

Timeframe: 90 minutes to 6 Hours

Percentage of subjects with unchanged accommodation from baseline (-1 hour)

Outcome measures

Measure	Phentolamine Ophthalmic Solution 0.75% n=244 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=124 Participants 2 drops in study eye and 1 drop in non-study eye, 1 hour post pharmacologically-induced mydriasis Phentolamine Ophthalmic Solution Vehicle: Phentolamine Ophthalmic Solution Vehicle
Percent of Subjects With Unchanged Accommodation From Baseline 90 Minutes · Unchanged from Baseline	155 Participants	65 Participants
Percent of Subjects With Unchanged Accommodation From Baseline 90 Minutes · Changed from Baseline	89 Participants	59 Participants
Percent of Subjects With Unchanged Accommodation From Baseline 2 Hours · Unchanged from Baseline	165 Participants	66 Participants
Percent of Subjects With Unchanged Accommodation From Baseline 2 Hours · Changed from Baseline	79 Participants	58 Participants
Percent of Subjects With Unchanged Accommodation From Baseline 3 Hours · Unchanged from Baseline	186 Participants	81 Participants
Percent of Subjects With Unchanged Accommodation From Baseline 3 Hours · Changed from Baseline	58 Participants	43 Participants
Percent of Subjects With Unchanged Accommodation From Baseline 6 Hours · Unchanged from Baseline	204 Participants	86 Participants
Percent of Subjects With Unchanged Accommodation From Baseline 6 Hours · Changed from Baseline	40 Participants	38 Participants

SECONDARY outcome

Timeframe: 6 hours

Change from Baseline in best-corrected distance visual acuity (BCDVA) under normal photopic lighting without glare conditions

Outcome measures

Measure	Phentolamine Ophthalmic Solution 0.75% n=244 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=124 Participants 2 drops in study eye and 1 drop in non-study eye, 1 hour post pharmacologically-induced mydriasis Phentolamine Ophthalmic Solution Vehicle: Phentolamine Ophthalmic Solution Vehicle
Change From Baseline in Best-Corrected Distance Visual Acuity (BCDVA) Under Normal Photopic Lighting Without Glare Conditions	0.3 letters Standard Deviation 3.73	-0.2 letters Standard Deviation 4.64

Adverse Events

Phentolamine Ophthalmic Solution 0.75%

Serious events: 0 serious events

Other events: 43 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

Measure	Phentolamine Ophthalmic Solution 0.75% n=244 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=124 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: Phentolamine Ophthalmic Solution Vehicle
Eye disorders Conjunctival Hyperaemia	10.7% 26/244 • 2 Days	0.00% 0/124 • 2 Days
General disorders Instillation site erythema	3.7% 9/244 • 2 Days	0.00% 0/124 • 2 Days
Nervous system disorders Dysgeusia	3.3% 8/244 • 2 Days	0.00% 0/124 • 2 Days

Additional Information

Drey Coleman, VP of Clinical Operations

Ocuphire

Phone: 813-404-1993

Email: dcoleman@ocuphire.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60