Trial Outcomes & Findings for Safety and Efficacy of Ophthalmic Phentolamine Mesylate in Glaucoma (NCT NCT03960866)

Results Overview

change from Baseline in mean diurnal IOP in the study eye

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

15 days

Results posted on

2023-09-13

Participant Flow

Participant milestones

Participant milestones
Measure	Nyxol Ophthalmic Solution 1% 1 drop in each eye daily (QD) at or before bedtime (8pm to 10pm) for 14 days Phentolamine Mesylate Ophthalmic Solution 1%: Topical Sterile Ophthalmic Solution	Nyxol Ophthalmic Solution Vehicle 1 drop in each eye daily (QD) at or before bedtime (8pm to 10pm) for 14 days Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution
Overall Study STARTED	19	20
Overall Study COMPLETED	19	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of Ophthalmic Phentolamine Mesylate in Glaucoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nyxol Ophthalmic Solution 1% n=19 Participants 1 drop in each eye daily (QD) at or before bedtime (8pm to 10pm) for 14 days Phentolamine Mesylate Ophthalmic Solution 1%: Topical Sterile Ophthalmic Solution	Nyxol Ophthalmic Solution Vehicle n=20 Participants 1 drop in each eye daily (QD) at or before bedtime (8pm to 10pm) for 14 days Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution	Total n=39 Participants Total of all reporting groups
Age, Continuous	58.1 years STANDARD_DEVIATION 13.23 • n=99 Participants	63.2 years STANDARD_DEVIATION 10.35 • n=107 Participants	60.7 years STANDARD_DEVIATION 11.97 • n=206 Participants
Sex: Female, Male Female	9 Participants n=99 Participants	13 Participants n=107 Participants	22 Participants n=206 Participants
Sex: Female, Male Male	10 Participants n=99 Participants	7 Participants n=107 Participants	17 Participants n=206 Participants
Race/Ethnicity, Customized White	11 Participants n=99 Participants	14 Participants n=107 Participants	25 Participants n=206 Participants
Race/Ethnicity, Customized Non-White	8 Participants n=99 Participants	6 Participants n=107 Participants	14 Participants n=206 Participants
Baseline Intraocular Pressure (Study Eye)	23.43 mmHg STANDARD_DEVIATION 1.675 • n=99 Participants	24.38 mmHg STANDARD_DEVIATION 2.097 • n=107 Participants	23.92 mmHg STANDARD_DEVIATION 1.939 • n=206 Participants

PRIMARY outcome

Timeframe: 15 days

Population: Patients underwent a Screening visit where they were included in the trial if they were at least 18 years of age with either OHT in both eyes or OAG in 1 eye with OHT in the fellow eye, which was previously untreated or treated with ≤2 ocular hypotensive medications.

change from Baseline in mean diurnal IOP in the study eye

Outcome measures

Outcome measures
Measure	Nyxol Ophthalmic Solution 1% n=18 Participants 1 drop in each eye daily (QD) at or before bedtime (8pm to 10pm) for 14 days Phentolamine Mesylate Ophthalmic Solution 1%: Topical Sterile Ophthalmic Solution	Nyxol Ophthalmic Solution Vehicle n=19 Participants 1 drop in each eye daily (QD) at or before bedtime (8pm to 10pm) for 14 days Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution
Intraocular Pressure	-2.30 mmHg Standard Deviation 2.986	-2.18 mmHg Standard Deviation 1.856

SECONDARY outcome

Timeframe: 15 days

Change from Baseline Pupil Diameter (Photopic Conditions)

Outcome measures

Outcome measures
Measure	Nyxol Ophthalmic Solution 1% n=19 Participants 1 drop in each eye daily (QD) at or before bedtime (8pm to 10pm) for 14 days Phentolamine Mesylate Ophthalmic Solution 1%: Topical Sterile Ophthalmic Solution	Nyxol Ophthalmic Solution Vehicle n=20 Participants 1 drop in each eye daily (QD) at or before bedtime (8pm to 10pm) for 14 days Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution
Pupil Diameter Day 8 (8AM)	-0.77 mm Standard Deviation 0.538	-0.07 mm Standard Deviation 0.555
Pupil Diameter Day 15 (8AM)	-0.77 mm Standard Deviation 0.550	-0.01 mm Standard Deviation 0.580

SECONDARY outcome

Timeframe: 15 days

Population: Full Analysis Data Set

Percentage of Subjects Achieving ≥1 line improvement in Distance Visual Acuity from Baseline measured at 4 meters (photopic conditions)

Outcome measures

Outcome measures
Measure	Nyxol Ophthalmic Solution 1% n=19 Participants 1 drop in each eye daily (QD) at or before bedtime (8pm to 10pm) for 14 days Phentolamine Mesylate Ophthalmic Solution 1%: Topical Sterile Ophthalmic Solution	Nyxol Ophthalmic Solution Vehicle n=20 Participants 1 drop in each eye daily (QD) at or before bedtime (8pm to 10pm) for 14 days Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution
Distance Visual Acuity	12 Participants	4 Participants

SECONDARY outcome

Timeframe: 15 days

Population: Full analytical sample

Conjunctival Hyperemia Category

Outcome measures

Outcome measures
Measure	Nyxol Ophthalmic Solution 1% n=19 Participants 1 drop in each eye daily (QD) at or before bedtime (8pm to 10pm) for 14 days Phentolamine Mesylate Ophthalmic Solution 1%: Topical Sterile Ophthalmic Solution	Nyxol Ophthalmic Solution Vehicle n=20 Participants 1 drop in each eye daily (QD) at or before bedtime (8pm to 10pm) for 14 days Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution
Conjunctival Hyperemia None	4 Participants	8 Participants
Conjunctival Hyperemia Mild	10 Participants	8 Participants
Conjunctival Hyperemia Moderate	3 Participants	4 Participants
Conjunctival Hyperemia Severe	2 Participants	0 Participants

Adverse Events

Nyxol Ophthalmic Solution 1%

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Nyxol Ophthalmic Solution Vehicle

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Nyxol Ophthalmic Solution 1% n=19 participants at risk 1 drop in each eye daily (QD) at or before bedtime (8pm to 10pm) for 14 days Phentolamine Mesylate Ophthalmic Solution 1%: Topical Sterile Ophthalmic Solution	Nyxol Ophthalmic Solution Vehicle n=20 participants at risk 1 drop in each eye daily (QD) at or before bedtime (8pm to 10pm) for 14 days Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution
Eye disorders Conjunctival Hyperemia	15.8% 3/19 • 14 Days All treatment-emergent adverse events (TEAEs)/adverse reactions occurring during the study (ie, once the subject has received 1 dose of study medication) were documented, regardless of the assumption of causal relationship. All TEAEs/adverse reactions were documented from the time the subject received the first dose of study medication until the subject's participation in the study had completed.	5.0% 1/20 • 14 Days All treatment-emergent adverse events (TEAEs)/adverse reactions occurring during the study (ie, once the subject has received 1 dose of study medication) were documented, regardless of the assumption of causal relationship. All TEAEs/adverse reactions were documented from the time the subject received the first dose of study medication until the subject's participation in the study had completed.
Eye disorders Eye Pruritis	5.3% 1/19 • 14 Days All treatment-emergent adverse events (TEAEs)/adverse reactions occurring during the study (ie, once the subject has received 1 dose of study medication) were documented, regardless of the assumption of causal relationship. All TEAEs/adverse reactions were documented from the time the subject received the first dose of study medication until the subject's participation in the study had completed.	0.00% 0/20 • 14 Days All treatment-emergent adverse events (TEAEs)/adverse reactions occurring during the study (ie, once the subject has received 1 dose of study medication) were documented, regardless of the assumption of causal relationship. All TEAEs/adverse reactions were documented from the time the subject received the first dose of study medication until the subject's participation in the study had completed.
General disorders Installation Site Discomfort	15.8% 3/19 • 14 Days All treatment-emergent adverse events (TEAEs)/adverse reactions occurring during the study (ie, once the subject has received 1 dose of study medication) were documented, regardless of the assumption of causal relationship. All TEAEs/adverse reactions were documented from the time the subject received the first dose of study medication until the subject's participation in the study had completed.	0.00% 0/20 • 14 Days All treatment-emergent adverse events (TEAEs)/adverse reactions occurring during the study (ie, once the subject has received 1 dose of study medication) were documented, regardless of the assumption of causal relationship. All TEAEs/adverse reactions were documented from the time the subject received the first dose of study medication until the subject's participation in the study had completed.

Additional Information

Mina Sooch

Ocuphire Pharma, Inc.

Phone: 248-681-9815

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place