Drugs / cyclopentolate

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) CYCLOGYL 1974-07-31 fda.gov

Trials 7 · a red edge is where a trial was stopped

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 43 trials
Phase 4 NCT03638726 Sep 2018 → Mar 2019 cataract Dar El Oyoun Hospital Unknown No outcome recorded
Phase 4 NCT02177539 May → Aug 2014 refractive error Pontificia Universidad Catolica de Chile Unknown No outcome recorded
Phase 4 NCT04838665 Sep 2011 retinopathy of prematurity University of the Philippines Completed No outcome recorded
Phase not applicable4 trials
NCT06914063 Mar → Jun 2025 overdue cycloplegia Superior University Active not recruiting No outcome recorded
NCT05614622 Nov 2020 → Jan 2022 Rabin Medical Center Completed No outcome recorded
NCT02909140 Sep 2016 → Aug 2018 cataract Johns Hopkins University Terminated No outcome recorded
NCT01054027 Mar → Nov 2007 retinopathy of prematurity Georgetown University Completed No outcome recorded
Also used as a comparator or background therapy in 6 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT00348166 Background Dec 2005 → Jun 2008 myopia KK Women's and Children's Hospital Withdrawn No outcome recorded
Phase 21 trial
Phase 2 NCT03851172 Background Mar → Dec 2019 cataract Assiut University Unknown No outcome recorded
Phase 31 trial
Phase 3 NCT02717871 Comparator Mar 2016 → Oct 2020 keratitis University Hospital, Geneva Completed No outcome recorded
Phase 42 trials
Phase 4 NCT06077682 Comparator Sep 2023 → Sep 2024 cycloplegia, esotropia, refractive error, vision disorder Islamic Hospital, Jordan Unknown No outcome recorded
Phase 4 NCT05442801 Comparator Mar → Jun 2022 cycloplegia Islamic Hospital, Jordan Completed No outcome recorded
Phase not applicable1 trial
NCT05204069 Background Jan → Sep 2021 amblyopia, anisometropia, strabismus Assistance Publique - Hôpitaux de Paris Completed No outcome recorded

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 13 sources stand behind the page.

FieldValueCited text
Known as cyclopentolate “Conventional Cycloplegic Drops (e.g., cyclopentolate) to provide a baseline for comparison with the rapid-onset treatment.” NCT06914063
12

NCT05204069

NCT03638726

NCT06077682

NCT00348166

NCT01054027

NCT02177539

NCT05614622

NCT04838665

NCT05442801

NCT03851172

NCT02909140

NCT02717871

Known as Cyclopentolate Hydrochloride “Multiple Alternate Instillation of Cyclopentolate Hydrochloride Dilate® Micro Labs Limited Bangalore and Phenylephrine Hydrochloride Mydfrin™ 25mg/mL (2.5%) Alcon Fort Worth Texas” NCT04838665
1

Cyclopentolate Hydrochloride 1.0% eye drops” NCT05614622

Known as Dilate “Multiple Alternate Instillation of Cyclopentolate Hydrochloride Dilate® Micro Labs Limited Bangalore and Phenylephrine Hydrochloride Mydfrin™ 25mg/mL (2.5%) Alcon Fort Worth Texas” NCT04838665
Route Topical “given as drops, prior to eye exam” NCT01054027