دورية أكاديمية
Phentolamine Eye Drops Reverse Pharmacologically Induced Mydriasis in a Randomized Phase 2b Trial.
| العنوان: | Phentolamine Eye Drops Reverse Pharmacologically Induced Mydriasis in a Randomized Phase 2b Trial. |
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| المؤلفون: | Karpecki PM; Kentucky College of Optometry, Pikeville, Kentucky., Foster SA; Athens Eye Care, Athens, Ohio., Montaquila SM; West Bay Eye Associates, Warwick, Rhode Island., Kannarr SR; Kannarr Eye Care, Pittsburg, Kansas., Slonim CB; Oculos Development Services, LLC, Tampa, Florida., Meyer AR; Ocuphire Pharma, Farmington Hills, Michigan., Sooch MP; Ocuphire Pharma, Farmington Hills, Michigan., Jaber RM; Ocuphire Pharma, Farmington Hills, Michigan., Charizanis K, Yousif JE; Ocuphire Pharma, Farmington Hills, Michigan., Klapman SA; Ocuphire Pharma, Farmington Hills, Michigan., Amin AT; Ocuphire Pharma, Farmington Hills, Michigan., McDonald MB; New York University Langone Medical Center, New York, New York., Horn GD; LasikPlus, Cincinnati, Ohio., Lazar ES; elCON Medical, Buffalo, New York., Pepose JS |
| المصدر: | Optometry and vision science : official publication of the American Academy of Optometry [Optom Vis Sci] 2021 Mar 01; Vol. 98 (3), pp. 234-242. |
| نوع المنشور: | Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Lippincott Williams & Wilkins Country of Publication: United States NLM ID: 8904931 Publication Model: Print Cited Medium: Internet ISSN: 1538-9235 (Electronic) Linking ISSN: 10405488 NLM ISO Abbreviation: Optom Vis Sci Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Hagerstown, MD : Lippincott Williams & Wilkins Original Publication: [Baltimore, MD] : Williams & Wilkins, c1989- |
| مواضيع طبية MeSH: | Adrenergic alpha-Antagonists/*pharmacology , Mydriatics/*administration & dosage , Phentolamine/*pharmacology , Pupil/*drug effects, Accommodation, Ocular/physiology ; Administration, Ophthalmic ; Adolescent ; Adult ; Cross-Over Studies ; Double-Blind Method ; Humans ; Male ; Ophthalmic Solutions ; Phenylephrine/administration & dosage ; Pupil Disorders ; Tropicamide/administration & dosage ; Young Adult |
| مستخلص: | Significance: After a dilated eye examination, many patients experience symptoms of prolonged light sensitivity, blurred vision, and cycloplegia associated with pharmacological mydriasis. Phentolamine mesylate ophthalmic solution (PMOS) may expedite the reversal of mydriasis in patients, potentially facilitating return to functional vision and reducing barriers to obtaining dilated eye examinations. Purpose: The protracted reversal time after pharmacologically induced pupil dilation impairs vision. We tested the hypothesis that PMOS rapidly reduces pupil diameter in this acute indication. Methods: In this double-masked placebo-controlled, randomized, two-arm crossover phase 2b trial, we evaluated the effects of one drop of 1% PMOS applied bilaterally in subjects who had their pupils dilated by one of two common mydriatic agents: 2.5% phenylephrine or 1% tropicamide. End points included change in pupil diameter, percent of subjects returning to baseline pupil diameter, and accommodative function at multiple time points. Results: Thirty-one subjects completed the study (15 dilated with phenylephrine and 16 with tropicamide). Change in pupil diameter from baseline at 2 hours after maximal dilation with 1% PMOS was -1.69 mm and was significantly greater in magnitude compared with placebo for every time point beyond 30 minutes (P < .05). At 2 hours, a greater percentage of study eyes given 1% PMOS returned to baseline pupil diameter compared with placebo (29 vs. 13%, P = .03), which was this also seen at 4 hours (P < .001). More subjects treated with PMOS in the tropicamide subgroup had at least one eye returning to baseline accommodative amplitude at 2 hours (63 vs. 38%, P = .01). There were no severe adverse events, with only mild to moderate conjunctival hyperemia that resolved in most patients by 6 hours. Conclusions: Phentolamine mesylate ophthalmic solution at 1% reversed medically induced pupil dilation more rapidly than placebo treatment regardless of which mydriatic was used (adrenergic agonists and cholinergic blockers) with a tolerable safety profile. Competing Interests: Conflict of Interest Disclosure: The publication of this article was sponsored by Ocuphire Pharma, Inc. ARM, MPS, RMJ, KC, JEY, SAK, and ATA are or were employees, directors/officers, or paid consultants for Ocuphire Pharma. PMK, MBM, ESL, JSP, and GDH are on the medical advisory board for Ocuphire Pharma. PMK, SAF, SMM, and SRK were principal investigators for this clinical trial funded by Ocuphire Pharma. CBS serves as Chief Medical Officer of Oculos Development Services, LLC, which was the contract research organization for this clinical trial. The authors indicated that they have no other conflicts of interest with regard to the content of this article. The authors listed report a financial conflict of interest (PMK, SAF, SMM, SRK, CBS, ARM, MPS, RMJ, KC, JEY, SAK, ATA, MBM, GDH, ESL, and JSP). The sponsor (Ocuphire) provided financial and material support and participated in study design, analysis, and interpretation. The authors were responsible for the preparation of this article and the decision to submit this article for publication. Each of the authors had (full/limited) access to the study data and takes full responsibility for their presentation in this article. (Copyright © 2021 American Academy of Optometry.) |
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| سلسلة جزيئية: | ClinicalTrials.gov NCT04024891 |
| المشرفين على المادة: | 0 (Adrenergic alpha-Antagonists) 0 (Mydriatics) 0 (Ophthalmic Solutions) 1WS297W6MV (Phenylephrine) N0A3Z5XTC6 (Tropicamide) Z468598HBV (Phentolamine) |
| تواريخ الأحداث: | Date Created: 20210226 Date Completed: 20210716 Latest Revision: 20230823 |
| رمز التحديث: | 20231215 |
| DOI: | 10.1097/OPX.0000000000001656 |
| PMID: | 33633016 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1538-9235 |
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| DOI: | 10.1097/OPX.0000000000001656 |