Trial Outcomes & Findings for Single Dose Study of Phentolamine Mesylate Eye Drops in Patients With Severe Night Vision Disturbances (NCT NCT04004507)

Last Updated: 2024-02-15

Results Overview

Average change in monocular contrast sensitivity scores under mesopic conditions at each of five spatial frequencies with and without glare. The tests were performed in a darkened room using the Optec 6500 instrument (Stereo Optical) using Slides 5-9 (spatial frequencies 1.5 - 18 cycles per degree), with the distance setting at "far", and with the light setting at "night". Subjects were asked to read each slide from left to right indicating if the lines were tilted to the left, the right or straight up and down until they provided 2 consecutive incorrect responses. The total number of correct responses for each slide was recorded.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

1 day

Results posted on

2024-02-15

Participant Flow

24 subjects were enrolled. Both eyes were treated and evaluated for efficay and safety.

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	Phentolamine Mesylate Ophthalmic Solution 1% 1 drop in each eye (QD) for one day. Phentolamine Mesylate Ophthalmic Solution 1%: Topical Sterile Ophthalmic Solution	Phentolamine Mesylate Ophthalmic Solution Vehicle 1 drop in each eye (QD) for one day. Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution
Overall Study STARTED	16 32	8 16
Overall Study COMPLETED	16 32	8 16
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Single Dose Study of Phentolamine Mesylate Eye Drops in Patients With Severe Night Vision Disturbances

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phentolamine Mesylate Ophthalmic Solution 1% n=32 eyes 1 drop in each eye (QD) for one day. Phentolamine Mesylate Ophthalmic Solution 1%: Topical Sterile Ophthalmic Solution	Phentolamine Mesylate Ophthalmic Solution Vehicle n=16 eyes 1 drop in each eye (QD) for one day. Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution	Total n=48 eyes Total of all reporting groups
Age, Continuous	42.1 years STANDARD_DEVIATION 14.6 • n=5 Participants	47.4 years STANDARD_DEVIATION 13.5 • n=7 Participants	43.9 years STANDARD_DEVIATION 19.9 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	5 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Pupil Diameter Illuminated	4.4 mm STANDARD_DEVIATION 0.6 • n=32 eyes	4.9 mm STANDARD_DEVIATION 0.8 • n=16 eyes	4.6 mm STANDARD_DEVIATION 1 • n=48 eyes
Trans-Illuminated Low Contrast Visual Acuity	33.1 Letters STANDARD_DEVIATION 5.4 • n=32 eyes	30.1 Letters STANDARD_DEVIATION 8.4 • n=16 eyes	32.1 Letters STANDARD_DEVIATION 10.0 • n=48 eyes

PRIMARY outcome

Timeframe: 1 day

Outcome measures

Outcome measures
Measure	Phentolamine Mesylate Ophthalmic Solution 1% n=32 Eyes 1 drop in each eye (QD) for one day. Phentolamine Mesylate Ophthalmic Solution 1%: Topical Sterile Ophthalmic Solution	Phentolamine Mesylate Ophthalmic Solution Vehicle n=16 Eyes 1 drop in each eye (QD) for one day. Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution
Contrast Sensitivity 18 Cycles with Glare	1.3 Patches Standard Deviation 1.8	0.3 Patches Standard Deviation 0.8
Contrast Sensitivity 3 Cycles without Glare	1.3 Patches Standard Deviation 1.5	0.7 Patches Standard Deviation 1.3
Contrast Sensitivity 6 Cycles without Glare	1.1 Patches Standard Deviation 1.4	0.5 Patches Standard Deviation 1.4
Contrast Sensitivity 12 Cycles without Glare	0.8 Patches Standard Deviation 1.6	-0.2 Patches Standard Deviation 1.0
Contrast Sensitivity 18 Cycles without Glare	0.5 Patches Standard Deviation 1.4	0.3 Patches Standard Deviation 0.9
Contrast Sensitivity 1.5 Cycles with Glare	0.6 Patches Standard Deviation 1.8	0.8 Patches Standard Deviation 1.5
Contrast Sensitivity 3 Cycles with Glare	0.9 Patches Standard Deviation 2.1	0.7 Patches Standard Deviation 1.5
Contrast Sensitivity 6 Cycles with Glare	1.4 Patches Standard Deviation 1.9	0.1 Patches Standard Deviation 1.3
Contrast Sensitivity 12 Cycles with Glare	1.7 Patches Standard Deviation 2.0	0.4 Patches Standard Deviation 1.0
Contrast Sensitivity 1.5 Cycles without Glare	1.0 Patches Standard Deviation 1.4	0.4 Patches Standard Deviation 1.4

SECONDARY outcome

Timeframe: 1 day

Average number of letters of improvement in the following parameters: 1. Distance high-contrast visual acuity under mesopic conditions (monocular, measured at 4 meters) 2. Distance high-contrast visual acuity under photopic conditions (monocular, measured at 4 meters) 3. Distance low-contrast visual acuity under mesopic conditions (monocular, measured at 4 meters) 4. Distance low-contrast visual acuity under photopic conditions (monocular, measured at 4 meters)

Outcome measures

Outcome measures
Measure	Phentolamine Mesylate Ophthalmic Solution 1% n=32 Eyes 1 drop in each eye (QD) for one day. Phentolamine Mesylate Ophthalmic Solution 1%: Topical Sterile Ophthalmic Solution	Phentolamine Mesylate Ophthalmic Solution Vehicle n=16 Eyes 1 drop in each eye (QD) for one day. Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution
Visual Acuity Distance high-contrast visual acuity under mesopic conditions	6.5 Letters Standard Deviation 7.2	1.1 Letters Standard Deviation 3.9
Visual Acuity Distance high-contrast visual acuity under photopic conditions	3.8 Letters Standard Deviation 7.6	0.1 Letters Standard Deviation 3.8
Visual Acuity Distance low-contrast visual acuity under mesopic conditions	8.0 Letters Standard Deviation 8.4	3.1 Letters Standard Deviation 4.5
Visual Acuity Distance low-contrast visual acuity under photopic conditions	7.3 Letters Standard Deviation 6.6	0.9 Letters Standard Deviation 3.6

SECONDARY outcome

Timeframe: 1 day

Subjective patient evaluations of vision quality at night (% rating their vision as improved)

Outcome measures

Outcome measures
Measure	Phentolamine Mesylate Ophthalmic Solution 1% n=16 Participants 1 drop in each eye (QD) for one day. Phentolamine Mesylate Ophthalmic Solution 1%: Topical Sterile Ophthalmic Solution	Phentolamine Mesylate Ophthalmic Solution Vehicle n=8 Participants 1 drop in each eye (QD) for one day. Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution
Self-Reported Vision Quality	69 Percentage	75 Percentage

SECONDARY outcome

Timeframe: 1 day

Average change in pupil diameter

Outcome measures

Outcome measures
Measure	Phentolamine Mesylate Ophthalmic Solution 1% n=32 Eyes 1 drop in each eye (QD) for one day. Phentolamine Mesylate Ophthalmic Solution 1%: Topical Sterile Ophthalmic Solution	Phentolamine Mesylate Ophthalmic Solution Vehicle n=16 Eyes 1 drop in each eye (QD) for one day. Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution
Pupil Diameter	-1.3 mm Standard Deviation 0.8	-0.2 mm Standard Deviation 0.5

Adverse Events

Phentolamine Mesylate Ophthalmic Solution 1%

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Phentolamine Mesylate 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

Dr. Marguerite McDonald

Ophthalmic Consultants Of Long Island

Phone: 7342501718

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place