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Die klinische Studie NCT06151587 für Myopie ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
A Phase 3 Clinical Study of QLM3004 in Delaying Myopia in Children Phase 3 735
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT06151587 untersucht Behandlung im Zusammenhang mit Myopie. Diese interventionsstudie der Phase 3 hat den Status offene rekrutierung und startete am 20. August 2023. Es ist geplant, 735 Teilnehmer aufzunehmen. Durchgeführt von Qilu Pharmaceutical Co., Ltd. wird der Abschluss für 1. Juni 2027 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 30. November 2023 aktualisiert.
Kurzbeschreibung
Efficacy and Safety Study of QLM3004 in Myopic Children
Ausführliche Beschreibung
The study was divided into 2 phases, with Stage 1 being the primary efficacy and safety confirmation phase and Stage 2 a post-withdrawal observation period.
Stage 1:To evaluate the safety and efficacy of 3 concentrations of QLM3004 compared to Vehicle (placebo)for slowing the progression of myopia in children over a 96-week treatment period.
Stage 2:subjects will enter Period 2 of the study, and Period 2 will be a ...
Mehr anzeigenOffizieller Titel
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Different Concentrations of QLM3004 in Delaying the Progression of Myopia in Children
Erkrankungen
MyopieWeitere Studien-IDs
- QLM3004-301
NCT-Nummer
Studienbeginn (tatsächlich)
2023-08-20
Zuletzt aktualisiert
2023-11-30
Studienende (vorauss.)
2027-06
Geplante Rekrutierung
735
Studientyp
Interventionsstudie
PHASE
Phase 3
Status
Offene Rekrutierung
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Doppelt verblindet
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellQLM3004 Concentration 1 Solution low dose | QLM3004 Concentration 1 Low dose of QLM3004 Ophthalmic Solution
1 drop in each eye at bedtime |
ExperimentellQLM3004 Concentration 2 Solution medium dose | QLM3004 Concentration 2 Medium dose of QLM3004 Ophthalmic Solution
1 drop in each eye at bedtime |
ExperimentellQLM3004 Concentration 3 Solution high dose | QLM3004 Concentration 3 High dose of QLM3004 Ophthalmic Solution
1 drop in each eye at bedtime |
Placebo-VergleichspräparatPlacebo Placebo Ophthalmic Solution | PLACEBO Vehicle |
Hauptergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Change from Baseline in spherical equivalent determined by cycloplegic autorefraction at week 96. | Effectiveness Evaluation | 96 week |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Kind
Mindestalter
6 Years
Zugelassene Geschlechter
Alle
- Age 6 to 12 years
- Myopia -1.00D to -4.00D spherical equivalent (SE) in both eyes as measured by cycloplegic autorefraction.
- Astigmatism ≤1.50 D in both eyes.
- Anisometropia ≤1.50 D SE.
- Informed consent signed by the subjects and/or their legal representatives
- Suffering from serious systemic diseases
- Any eye disease that affect vision or refractive error
- Current or prior history of manifest strabismus, amblyopia, or other ocular pathologic changes
- Acute inflammatory disease or active infection of the eye in either eye, or a history of chronic ocular inflammation or recurrent episodes of ocular inflammation
- Best corrected distance visual acuity in both eyes<4.9
- Abnormal intra-ocular pressure (>21 mmHg or difference between two eyes >5mmHg)
- Current or previous form of myopia control, including but not limited to drugs, orthokeratology, progressive addition lenses, bifocal lenses, etc.
- Systemic or topical use of medications within 3 months that interfere with efficacy evaluation (excluding optometry)
- Allergy or hypersensitivity to atropine, excipients, cyclopentolate or fluorescein sodium
- Participants for whom the clinical significance of ophthalmologic examination abnormalities indicate that one or both eyes are not suitable candidates for treatment based upon the Investigator's medical judgment
- Participation of the drug clinical trial within three month and the device clinical trial within one month
- Anticipated long-term use of ocular or systemic oral corticosteroids during the study period
- Any other condition not suitable for the study per investigator's judgement
Qilu Pharmaceutical Co., Ltd.Zentrale Studienkontakte
Kontakt: Zhenjiang Wang, 0531-55821369, [email protected]
1 Studienstandorte in 1 Ländern
Zhejiang
The Affiliated Eye Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China
jia Qu, M.D., Kontakt, 0577-88068860, [email protected]
Offene Rekrutierung