Last update 21 Nov 2024

Cyclopentolate Hydrochloride

Last update 21 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

(±)-cyclopentolate, 1-hydroxy-α-phenylcyclopentaneacetic acid 2-(dimethylamino)ethyl ester, 2-(dimethylamino)ethyl 1-hydroxy-α-phenylcyclopentaneacetate

+ [16]

Target

mAChRs

Mechanism

mAChRs antagonists(Muscarinic acetylcholine receptor antagonists)

Therapeutic Areas

Nervous System DiseasesEye DiseasesOther Diseases

Active Indication

Eye DiseasesCycloplegiaIritis+ [1]

Inactive Indication-

Originator Organization

Santen Pharmaceutical Co., Ltd.

Active Organization

Santen Pharmaceutical Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

JP (23 Sep 1971),

Eye Diseases

Regulation-

Structure

Molecular FormulaC17H26ClNO3

InChIKeyRHKZVMUBMXGOLL-UHFFFAOYSA-N

CAS Registry5870-29-1

View All Structures (2)

Clinical Trials associated with Cyclopentolate Hydrochloride

ChiCTR2400084750 / SuspendedEarly Phase 1IIT

Comparison of the effects of pupil dilation and ciliary muscle paralysis of 1% tropicamide, 0.5% tropicamide and 1% cyclopentolate

Start Date31 May 2024

Sponsor / Collaborator-

NCT06077682 / RecruitingPhase 4IIT

Tropicamide Versus Cyclopentolate for Cycloplegic Refraction in Pediatric Patients With Esotropia: A Randomized Clinical Trial

The primary outcome of this study is to compare cyclopentolate 1% and tropicamide 1% for cycloplegic refractions in pediatric populations with esotropia. This will be a prospective double-blinded randomized clinical trial (RCT), multi-center, with randomized sequencing of cycloplegic agent; each patient received one agent at one visit, and the other agent in the next visit (2 different visits ≥ 1 week apart) within 3 months.

Start Date01 Sep 2023

Sponsor / Collaborator

The Islamic Hospital

[+2]

NCT05442801 / CompletedPhase 4IIT

Tropicamide Versus Cyclopentolate Objective Refraction in Pediatric Population

The primary outcome of this study is to compare cyclopentolate 1% and tropicamide 1% for cycloplegic refractions in pediatric populations. This will be a prospective double-blinded randomized clinical trial (RCT), multi center, with randomized sequencing of cycloplegic agent; each patient received one agent at one visit, and the other agent in the next visit (2 different visits ≥ 1 week apart) within 3 months.

Start Date01 Mar 2022

Sponsor / Collaborator

The Islamic Hospital

100 Clinical Results associated with Cyclopentolate Hydrochloride

100 Translational Medicine associated with Cyclopentolate Hydrochloride

100 Patents (Medical) associated with Cyclopentolate Hydrochloride

578

Literatures (Medical) associated with Cyclopentolate Hydrochloride

01 Dec 2024·American Journal of Ophthalmology

Intracameral Anaesthetic Mydriatic Versus Topical Mydriasis in Pediatric Cataract Surgery: A Randomized Control Study

Article

Author: Gupta, Kajree ; Sen, Indu ; Sukhija, Jaspreet ; Kumari, Kiran ; Kaur, Savleen

PURPOSETo compare pupil dynamics after using premixed intracameral anesthetic mydriatic combination (ICAM) of phenylephrine (0.31%), tropicamide (0.02%), and lidocaine (1%) versus topical mydriatic (TM) drops consisting of tropicamide 0.8%, phenylephrine 5%, and cyclopentolate 0.5% in pediatric cataract surgery.DESIGNRandomized, masked, fellow eye-controlled trial.SETTINGTertiary eye care facility.STUDY POPULATIONChildren ≤12 years of age with bilateral cataracts planned for surgery. One eye was randomized to receive ICAM and the other eye (control) TM drops.INTERVENTIONCommercially available ICAM that was injected at the beginning of surgery or TM 3 times at an interval of 30 minutes, 1 hour before the scheduled time of surgery. The other treatment was administered for the second eye cataract surgery.MAIN OUTCOME MEASUREPupil dynamics at various points of surgery were studied by a masked observer.RESULTSSixty-three patients (126 eyes) were randomized to receive ICAM in 1 eye (group 1) or TM drops (group 2). The mean age of the children in the study was 15.7 ± 24.3 months (range 3 months to 5 years). Adequate mydriasis with a single injection was achieved in 93.5% of patients in group 1 and 88.8% of patients in group 2 without additional pharmacotherapy or intervention. The mean pupillary diameter increased from 1.78 mm to 5.1 mm after injection of 1 unit of ICAM and from 1.75 mm to 6.06 mm with TM drops (P < .0001). The maximum pupillary dilation achieved was 6.06 ± 1.17 mm in group 1 and 6.75 ± 1.07 mm in group 2 (P = .004). The average change in pupillary size from injection of drug until the end of surgery was positive in group 1 (0.75 ± 0.98 mm) and negative in group 2 (-0.3348 ± 2.57 mm), ie, there was a relative miosis in group 2 toward the end of surgery (P = .001).CONCLUSIONSTopical drugs achieved a larger maximum pupil size compared with ICAM. However, ICAM provided adequate and stable mydriasis without the need for augmentation compared with topical drops in children undergoing cataract surgery.

01 Nov 2024·European Journal of Ophthalmology

The etiology, diagnostics, and treatment of the spasm of the near reflex - a narrative review

Review

Author: Szczęśniak, Michalina ; Kopacz, Wojciech ; Sikorska, Ewa ; Maciejewicz, Piotr ; Rajca, Martyna ; Sikorski, Piotr ; Kasarełło, Kaja ; Koper, Mateusz

Physiological adaptation of the eye to the visual perception of near objects consists of the “near triad”: convergence, accommodation, and pupil miosis. Normally, these tend to revert when one stops fixating on a near object. Spasm of the near reflex (SNR) is a pathological phenomenon, which manifests itself by the persistence of the above-mentioned adjustments, which prevents the eye from returning to its relaxed state. In this narrative review, we aim to summarize the etiology, diagnostics, treatment, and prevention of SNR. The literature review was performed by searching online databases. The clinical presentation of SNR is diverse; it presents as isolated accommodative spasm more frequently than impairment of all three components of the near triad. Patients usually present with fluctuations in visual acuity, blurred vision, diplopia, and asthenopia. The etiology is not fully understood. Potential causes include neuroanatomic, organic, and psychogenic disorders. The diagnosis is clinical, based on the constellation of symptoms and assessment of the near triad. The diagnostic golden standard is a cycloplegic examination of refraction, preferably using cyclopentolate hydrochloride (1%, 0.5%, or 0.1% solution). The first-line treatment requires the administration of a cycloplegic drug in combination with plus lenses, flipper lenses, optical fogging, or miotics. For secondary cases, causal treatment should be implemented. Prevention of SNR should be based on eliminating modifiable risk factors. We propose including screening for SNR symptoms in every ophthalmic examination, especially among patients with psychogenic or neural disorders, after brain trauma, or young adults spending much time in front of computer screens.

01 Nov 2024·European Journal of Ophthalmology

Mydriasis for retinopathy of prematurity screening in Europe: A cross-sectional online survey

Article

Author: Diamanti, Elisavet ; Bougioukas, Konstantinos I. ; Seliniotaki, Aikaterini K. ; Ziakas, Nikolaos ; Moutzouri, Stella ; Mataftsi, Asimina ; Lithoxopoulou, Maria

Purpose To compile real-time data on the preferred mydriasis practice patterns for retinopathy of prematurity (ROP) screening in Europe. Methods A cross-sectional online survey was conducted from December 2022 to January 2023, using a self-report online questionnaire which was distributed via email to the members of the European Pediatric Ophthalmological Society and the Greek National ROP Task Force. A six-week period of recruitment was determined, and a reminder email was sent after two weeks. Descriptive statistics were used to explore the data, which was summarized with frequencies and percentages. Results Sixty-six responses were recorded (response rate: 29.5%), representing practices in 55 Neonatal Intensive Care Units from 21 European countries. In 94.5%, the applied mydriatic regimen consists of phenylephrine with at least one muscarinic antagonist, either tropicamide or cyclopentolate. The concentration of phenylephrine ranges from 0.5% to 5%, of tropicamide from 0.25% to 1%, and of cyclopentolate from 0.2% to 1%. The most commonly used regimen (43.6%) contains phenylephrine 2.5% and tropicamide 0.5%, administered either combined or separately. About 54.5% of the reported mydriatic solutions are non-commercial, in-house preparations. Systemic adverse events, including oxygen desaturation, bradycardia and cardiopulmonary arrest were reported in 14.5%. Conclusion There is considerable heterogeneity in the applied mydriatic regimens for ROP screening in Europe, reflecting the absence of universal guidelines. The wide use of in-house preparations underlines the gap in the pharmaceutical industry. Concern should be raised against the wide use of undiluted commercial drugs, that reach adult dose, in the fragile population of preterm infants.

News (Medical) associated with Cyclopentolate Hydrochloride

12 Aug 2024

·www.prnewswire.com

OcuMension acquires rights to Alcon eye drops in exchange for a 16.7% equity stake, signaling the commencement of comprehensive strategic relationship

SHANGHAI, Aug. 12, 2024 /PRNewswire/ -- On August 13th 2024, Ocumension Therapeutics (" OcuMension") announced an agreement with Alcon Inc. (" Alcon", and collectively with OcuMension, the " Parties") where OcuMension will acquire or secure commercialization rights in China to a portfolio of Alcon dry eye treatments and procedural drops, including several commercially available products and one development-stage product. The scope of the agreement will also cover areas of R&D, manufacturing and commercialization in China. In connection with the transfer of these rights, OcuMension will issue 139,161,120 shares to Alcon, accounting for 16.71% of the total share capital (post-issuance). Consequently, Alcon becomes one of the largest shareholders of OcuMension. Under the terms of the arrangement, each company has granted the other company a right of first negotiation over future products. OcuMension, as a leading Chinese ophthalmic pharmaceutical platform company, focuses on integrating comprehensive capabilities across the entire lifecycle of ophthalmic drug development—from research and development to commercialization. OcuMension possesses a portfolio of 25 pharmaceutical assets. Alcon, the global leader in eye care, offers a broad portfolio of products to enhance sight and improve lives for patients in more than 140 countries. Under this arrangement, OcuMension will acquire outright, Tears Natural® Forte, Bion Tears, Alcaine®, Fluorescite, and Cyclogyl, in the Chinese market and the commercialization rights in China to Systane® Ultra and AR-15512, a novel topical drug candidate for dry eye. Under the terms of this agreement, OcuMension will manufacture those products acquired outright for China after a transition period. OcuMension will also develop, manufacture and commercialize AR-15512 in China. The addition of these seven mature products and AR-15512 to OcuMension's portfolio is expected to further enhance OcuMension's leadership in the ophthalmology field in the China market. Through the acquisition of these products, OcuMension expects to be capable of providing more comprehensive and advanced treatment solutions, further meeting patient needs and expanding market share. The Parties expect that the framework of this agreement will allow both Parties to further promote technological advancements and innovations in the field of ophthalmology. Ophthalmic diseases are internationally recognized as one of the highly focused medical sub-sectors, with innovative treatment solutions for ophthalmology still awaiting development. Based on this, OcuMension will continue to focus on bringing safer, more efficient, and cutting-edge treatment solutions to global ophthalmic patients, meeting the growing medical needs of patients. About Alcon Alcon helps people see brilliantly. As the global leader in eye care with a heritage spanning over 75 years, Alcon offers the broadest portfolio of products to enhance sight and improve people's lives. Alcon's Surgical and Vision Care products touch the lives of more than 260 million people in over 140 countries each year living with conditions like cataracts, glaucoma, retinal diseases and refractive errors. Alcon's more than 25,000 associates are enhancing the quality of life through innovative products, partnerships with Eye Care Professionals and programs that advance access to quality eye care. Learn more at . About OcuMension OcuMension is a China-based ophthalmic pharmaceutical platform company dedicated to identifying, developing and commercializing first- or best-in-class ophthalmic therapies. OcuMension's vision is to provide a world-class pharmaceutical total solution to address significant unmet ophthalmic medical needs in China. Since its inception, OcuMension has focused on building a platform integrating specialized capabilities in each major functionality involved in an ophthalmic drug's development cycle, from research and development, manufacturing to commercialization. OcuMension believes its platform positions it well to achieve leadership in China ophthalmology, with a first-mover advantage over future competitors. Advisors Morrison Foerster acted as legal advisor to OcuMension in this transaction. Lazard acted as financial advisor to Alcon and Gibson Dunn as its legal advisor. SOURCE OcuMension

AcquisitionLicense out/in

100 Deals associated with Cyclopentolate Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D01002	Cyclopentolate Hydrochloride	S01FA04	DB00979

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Eye Diseases	JP	Santen Pharmaceutical Co., Ltd.	23 Sep 1971
Cycloplegia	-	-	-
Cycloplegia	US	-	-
Iritis	-	-	-
Mydriasis	US	-	-
Mydriasis	-	-	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02909140 (CTgov)	Not Applicable	Cataract	3	Topical phenylephrine 2.5%+Topical cyclopentolate 1%+Intracameral Lidocaine 1% (Topical Mydriasis)	suvwuqgjep(xoszbjolln) = ikjavqadbq rxytmguevv (naodvvyftl, borlmoardx - sekennyews) View more	-	10 Sep 2019
				Intracameral Lidocaine 1% (Intracameral Mydriasis)	kyuwucfnru(vikxikqznp) = mckopcnwko jwukbhszhy (pmdpqslxma, jthxgqiiwf - ctzewxngam) View more
Pubmed \| Curr Eye Res	Not Applicable	Retinopathy of Prematurity	25	Cyclopentolate	(bsosquukct) = Preterm infants undergoing Retinopathy of Prematurity Eye Exams (ROPEE) may experience adverse events, possibly from systemic absorption of cyclopentolate. wdldilukor (ohdxfmsdit ) View more	-	01 Dec 2016
				Cyclopentolate
ARVO2015	Not Applicable	-	8	Cyclopentolate 1%	(unbnkohvsf) = bqdoevbhgc qcfbdlfwaz (nqevfqmltd ) View more	-	01 Jun 2015
ARVO2013	Not Applicable	Myopia	28	cyclopentolate	hekqtbtfje(iabsngmars) = ezlxuuqdpf jjbiqnjqlz (vurqqtiyxi ) View more	-	01 Jun 2013
Multi-Ethnic Pediatric Eye Disease Study (ARVO2008)	Not Applicable	Refractive Errors	24	Cyclopentolate	bixkidpksu(ldjdkbxcbb) = shwwumzjsj gvleelucrs (pjmyljlyrj, 0.85) View more	Positive	01 May 2008
				Atropine	bixkidpksu(ldjdkbxcbb) = oiapyjvmeh gvleelucrs (pjmyljlyrj, 0.85)
P114 (AAO2000)	Not Applicable	-	-	Tropicamide 1%	ozvcoughny(ybyouscsgp) = qqmhqmdqxm uivtwgwdqe (mernzvmgdw, 0.78)	-	22 Oct 2000
				Cyclopentolate 1%	ozvcoughny(ybyouscsgp) = rfwtsivdpo uivtwgwdqe (mernzvmgdw, 0.78)

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