Page last updated: 2024-11-06

phentolamine and Afferent Pupillary Defect

phentolamine has been researched along with Afferent Pupillary Defect in 1 studies

Phentolamine: A nonselective alpha-adrenergic antagonist. It is used in the treatment of hypertension and hypertensive emergencies, pheochromocytoma, vasospasm of RAYNAUD DISEASE and frostbite, clonidine withdrawal syndrome, impotence, and peripheral vascular disease.
phentolamine : A substituted aniline that is 3-aminophenol in which the hydrogens of the amino group are replaced by 4-methylphenyl and 4,5-dihydro-1H-imidazol-2-ylmethyl groups respectively. An alpha-adrenergic antagonist, it is used for the treatment of hypertension.

Research

Studies (1)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's0 (0.00)29.6817
2010's0 (0.00)24.3611
2020's1 (100.00)2.80

Authors

AuthorsStudies
Karpecki, PM1
Foster, SA1
Montaquila, SM1
Kannarr, SR1
Slonim, CB1
Meyer, AR1
Sooch, MP1
Jaber, RM1
Charizanis, K1
Yousif, JE1
Klapman, SA1
Amin, AT1
McDonald, MB1
Horn, GD1
Lazar, ES1
Pepose, JS1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Randomized, Cross-Over, Double-Masked, Placebo-Controlled Study of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution to Reverse Pharmacologically Induced Mydriasis in Normal Healthy Subjects[NCT04024891]Phase 232 participants (Actual)Interventional2019-08-13Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Pupil Diameter (Change From Max)

Change in pharmacologically-induced mydriatic (maximum) pupil diameter at 2 hours post-treatment in the study eye. (NCT04024891)
Timeframe: 2 hours

Interventionmm (Least Squares Mean)
Phentolamine Mesylate Ophthalmic Solution 1%-1.69
Phentolamine Mesylate Ophthalmic Solution Vehicle-0.69

Best Corrected Distance Visual Acuity (BCDVA) Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Light Box Chart (Letters) at 4 Meters (Change From Baseline)

Change from baseline (-1 hour) in Best Corrected Distance Visual Acuity at each time point (0 min, 30 mins, 1 hour, 2 hours, 6 hours) in Study Eye (NCT04024891)
Timeframe: 0 mins, 30 mins, 1 hour, 2 hours, 4 hours, 6 hours

,
InterventionLetters Read (Mean)
0 mins30 mins1 hour2 hours4 hours6 hours
Phentolamine Mesylate Ophthalmic Solution 1%-0.45-0.550.290.651.060.45
Phentolamine Mesylate Ophthalmic Solution Vehicle-0.81-0.55-0.100.160.100.90

Conjunctival Hyperemia (Eye Redness) Assessed Visually With the Brien Holden Vision Institute (Formerly Corneal and Contact Lens Research Unit, or CCLRU) Bulbar Redness Scale (0-3)

Conjunctival hyperemia at each timepoint (0 min, 30 min, 1 hour, 2 hours, 4 hours, 6 hours), for study eye; in all subjects. Scale 0-3 (None, Mild, Moderate, Severe) (NCT04024891)
Timeframe: 0 min, 30 min, 1 hour, 2 hours, 4 hours, 6 hours

,
Interventionscore on a scale (0-3) (Mean)
Baseline (-1 hr)0 min30 min1 hr2 hr4 hr6 hr
Phentolamine Mesylate Ophthalmic Solution 1%0.450.231.521.551.421.100.81
Phentolamine Mesylate Ophthalmic Solution Vehicle0.350.290.420.450.450.420.35

Distance-Corrected Near Visual Acuity (DCNVA) Measured by Standard Reading Card (Original Series Sloan Letter ETDRS Card at 16 Inches, LogMAR Units) (Change From Baseline)

Change from baseline (-1 hour) in Distance Corrected Near Visual Acuity at each time point (0 min, 30 mins, 1 hour, 2 hours, 6 hours) in Study Eye (NCT04024891)
Timeframe: 0 mins, 30 mins, 1 hour, 2 hours, 4 hours, 6 hours

,
InterventionLogMar (Mean)
0 mins30 mins1 hour2 hours4 hours6 hours
Phentolamine Mesylate Ophthalmic Solution 1%0.140.090.050.030.00-0.02
Phentolamine Mesylate Ophthalmic Solution Vehicle0.130.090.070.000.010.00

Pupil Diameter (Change From Max)

Change in pharmacologically-induced mydriatic (maximum) pupil diameter at remaining timepoints (30 min, 1 hours, 4 hours, 6 hours) (NCT04024891)
Timeframe: 30 min, 1 hours, 4 hours, 6 hours

,
Interventionmm (Least Squares Mean)
30 minutes1 hour4 hours6 hours
Phentolamine Mesylate Ophthalmic Solution 1%-0.06-0.77-2.83-3.24
Phentolamine Mesylate Ophthalmic Solution Vehicle-0.13-0.29-1.69-2.54

Pupil Diameter Return to Baseline

Percent of Subjects Achieving Pupil Diameter No More Than 0.5 mm Above Baseline by Time Point with either phenylephrine or tropicamide (NCT04024891)
Timeframe: 0 min, 1 hour, 2 hours, 4 hours, 6 hours

,
InterventionParticipants (Count of Participants)
0 min1 hour2 hour4 hour6 hour
Phentolamine Mesylate Ophthalmic Solution 1%26112431
Phentolamine Mesylate Ophthalmic Solution Vehicle3361228

Accommodation Measured by the Near Point Rule (Diopters) (Change From Baseline), Percent With Unchanged Accommodation

"Change from baseline (-1 hour) in accommodation at each time point (0 min, 2 hours, 4 hours) with Tropicamide and Phenylephrine~Worsening of accommodation is defined as an amplitude decrease of greater than 1 diopter compared to baseline" (NCT04024891)
Timeframe: 0 min, 2 hours, 4 hours

InterventionParticipants (Count of Participants)
Dilated with Tropicamide, 0 min72524499Dilated with Tropicamide, 0 min72524500Dilated with Tropicamide, 2 hr72524499Dilated with Tropicamide, 2 hr72524500Dilated with Tropicamide, 4 hr72524499Dilated with Tropicamide, 4 hr72524500Dilated with Phenylephrine, 0 min72524499Dilated with Phenylephrine, 0 min72524500Dilated with Phenylephrine, 2 hr72524499Dilated with Phenylephrine, 2 hr72524500Dilated with Phenylephrine, 4 hr72524499Dilated with Phenylephrine, 4 hr72524500
Unchanged AccommodationChanged Accommodation (≥1 D)
Phentolamine Mesylate Ophthalmic Solution 1%13
Phentolamine Mesylate Ophthalmic Solution Vehicle14
Phentolamine Mesylate Ophthalmic Solution 1%7
Phentolamine Mesylate Ophthalmic Solution Vehicle3
Phentolamine Mesylate Ophthalmic Solution 1%9
Phentolamine Mesylate Ophthalmic Solution 1%11
Phentolamine Mesylate Ophthalmic Solution Vehicle7
Phentolamine Mesylate Ophthalmic Solution 1%5
Phentolamine Mesylate Ophthalmic Solution Vehicle9
Phentolamine Mesylate Ophthalmic Solution 1%10
Phentolamine Mesylate Ophthalmic Solution Vehicle11
Phentolamine Mesylate Ophthalmic Solution Vehicle4
Phentolamine Mesylate Ophthalmic Solution Vehicle13
Phentolamine Mesylate Ophthalmic Solution 1%4
Phentolamine Mesylate Ophthalmic Solution Vehicle2
Phentolamine Mesylate Ophthalmic Solution 1%12
Phentolamine Mesylate Ophthalmic Solution 1%3

Trials

1 trial available for phentolamine and Afferent Pupillary Defect

ArticleYear
Phentolamine Eye Drops Reverse Pharmacologically Induced Mydriasis in a Randomized Phase 2b Trial.
    Optometry and vision science : official publication of the American Academy of Optometry, 2021, 03-01, Volume: 98, Issue:3

    Topics: Accommodation, Ocular; Administration, Ophthalmic; Adolescent; Adrenergic alpha-Antagonists; Adult;

2021