Evidence map›Paper›PMID 36209072›Full record

Trial reportBMC ophthalmology2022

A randomized phase 2 clinical trial of phentolamine mesylate eye drops in patients with severe night vision disturbances.

Jay Pepose, Mitchell Brigell, Eliot Lazar, Curtis Heisel, Jonah Yousif, Kavon Rahmani, Ajay Kolli, Min Hwang, Cara Mitrano, Audrey Lazar and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC ophthalmology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04004507 (Single Dose Study of Phentolamine Mesylate Eye Drops in Patients With Severe Night Vision Disturbances), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 31% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04004507 phase2completednot on this map

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

TypeinterventionalSponsorOcuphire Pharma, Inc.Ran2007 to 2008Enrolled24ConditionsDecrease in Night Vision, Disturbance, Vision, LossArmsPhentolamine Mesylate Ophthalmic Solution 1%, Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 4 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 3 institutions in 1 country.

Jay PeposePepose Vision Institute, St. Louis, MO, USA.
Mitchell BrigellOcuphire Pharma, Inc., 37000 Grand River Ave., Suite 120, Farmington Hills, MI, 48335, USA.
Eliot LazarelCON Medical, Buffalo, NY, USA.
Curtis HeiselOcuphire Pharma, Inc., 37000 Grand River Ave., Suite 120, Farmington Hills, MI, 48335, USA.
Jonah YousifOcuphire Pharma, Inc., 37000 Grand River Ave., Suite 120, Farmington Hills, MI, 48335, USA.
Kavon RahmaniOcuphire Pharma, Inc., 37000 Grand River Ave., Suite 120, Farmington Hills, MI, 48335, USA. kavonrah@umich.edu.
Ajay KolliOcuphire Pharma, Inc., 37000 Grand River Ave., Suite 120, Farmington Hills, MI, 48335, USA.
Min HwangOcuphire Pharma, Inc., 37000 Grand River Ave., Suite 120, Farmington Hills, MI, 48335, USA.
Cara MitranoOcuphire Pharma, Inc., 37000 Grand River Ave., Suite 120, Farmington Hills, MI, 48335, USA.
Audrey LazarOcuphire Pharma, Inc., 37000 Grand River Ave., Suite 120, Farmington Hills, MI, 48335, USA.
Konstantinos CharizanisOcuphire Pharma, Inc., 37000 Grand River Ave., Suite 120, Farmington Hills, MI, 48335, USA.
Mina SoochOcuphire Pharma, Inc., 37000 Grand River Ave., Suite 120, Farmington Hills, MI, 48335, USA.
Marguerite McDonaldDepartment of Ophthalmology, New York University Langone Medical Center, New York, NY, USA.
Ocuphire Pharma (United States) · USNYU Langone Health · USPepose Vision Institute · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeDim light vision disturbances (DLD) comprise a wide range of symptoms affecting the quality of vision at low illumination including glare, halos, and starbursts. This exploratory study investigated 1.0% phentolamine mesylate ophthalmic solution (PMOS) as a treatment to improve vision and image quality for patients with DLD.

methodsIn this placebo-controlled, randomized, double-masked clinical trial, 24 adult patients with severe DLD were randomized in a 2:1 ratio to receive either one dose of PMOS or placebo. Subjects were eligible if they reported experiencing severe night vision difficulty that was not eliminated by distance spectacle correction and scored ≥0.3 log units below the normal range of contrast sensitivity assessed under mesopic conditions with glare at ≥2 spatial frequencies. Key efficacy outcomes were change from baseline in pupil diameter, contrast sensitivity, and visual acuity. Safety measures including intraocular pressure, conjunctival hyperemia, and systemic effects were also assessed.

resultsEight subjects were randomized to placebo (63% female; mean age 47 years) and 16 were randomized to PMOS (75% female; mean age 42 years). Mean (SD) pupil diameter of PMOS-treated subjects decreased significantly - 1.3 mm (0 to - 2.8 mm) with p < 0.0001. Mean contrast sensitivity with glare in PMOS-treated subjects improved significantly post-treatment at spatial frequencies 3, 6, 12, and 18 cycles per degree (p ≤ 0.03). PMOS also demonstrated improvements in the numbers of letters read for mesopic and photopic, high- and low-contrast visual acuity (LCVA). Importantly, a statistically greater proportion of PMOS-treated eyes registered mesopic LCVA 5 letter (69% vs. 31%, p = 0.029) and 10 letter (34% vs. 6%, p = 0.04) improvement, with a trend at 15 letters (19% vs. 0%, p = 0.16). PMOS was well tolerated with the only reported side effect being a mild increase in conjunctival hyperemia.

conclusionPMOS was well tolerated and effectively reduced pupil size with improvements in contrast sensitivity and visual acuity in adults with severe DLD. Future Phase 3 studies should be conducted to further evaluate its potential to treat DLD.

trial registrationThe trial registration number is NCT04004507 (02/07/2019). Retrospectively registered.

Indexed as

HyperemiaNight BlindnessAdultContrast SensitivityFemaleGlareHumansMaleMiddle AgedNight VisionOphthalmic SolutionsPhentolamineVision DisordersOphthalmic SolutionsPhentolamineDim Light DisturbanceDLDGlareHalosNight Vision DisturbanceNVDPhentolaminePhotic PhenomenonStarburst

Identifiers

PMID36209072
PMCPMC9548101
OpenAlexW4303684507

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.