Clinical Trials Logo
  1. Home
  2. Myopia
  3. NCT06209281

A Phase III Clinical Study of the Efficacy and Safety of Two Low-concentration Atropine Sulfate Eye Drops — Mini-CHAMP  

Myopia Clinical Trial

Official title:
A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase III Clinical Study of the Efficacy and Safety of Two Low-concentration Atropine Sulfate Eye Drops in Slowing the Progression of Myopia in Children

Clinical Trial Summary

This study was a randomized, double-blind, placebo-controlled, multicenter, superiority design, phase III clinical trial to compare the efficacy and safety of two low-concentration atropine sulfate eye drops versus placebo in delaying myopia progression in children.

Clinical Trial Description

Eligible subjects were screened and randomly assigned to the placebo control group, the lower dose group, and the lower dose group. Subjects received the study drug in both eyes, 1 drop each time, once every night before sleep, for continuous administration.A total of 526 subjects were planned to be enrolled。 Statistical analyses were performed with the use of SAS software, version 9.4, without any specific description. All statistical tests were two-sided at a 0.05 level. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06209281
Study type Interventional
Source Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
Contact
Status Active, not recruiting
Phase Phase 3
Start date May 13, 2022
Completion date August 2024
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04923841 - Myopia Control Using Bright Light Therapy, Myopic Defocus and Atropine N/A
Active, not recruiting NCT04080128 - Examination of Myopia Progression and Soft Bifocal Contact Lens Myopia Control N/A
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Completed NCT04604405 - Effects of 650nm Low Energy Light on Human Retina and Choroid Microcirculation N/A
Recruiting NCT05594719 - The Effect of Sun-like Spectrum With Different Spectrum Composition on Retinal Blood Flow N/A
Completed NCT05594732 - The Effects of Different Outdoor Light Exposure Modes on Retinal Blood Flow N/A
Completed NCT04492397 - Comparing The Performance Of Two Different Daily Disposable Lenses (MIKI) N/A
Completed NCT04536571 - Vision Stability and Preference for Soft Toric vs. Soft Spherical Contact Lenses N/A
Completed NCT06046209 - Comparing a Monthly Replacement Lens Versus a Daily Disposable Lens N/A
Recruiting NCT06344572 - Pivotal Study of SAT-001 in Treatment of Pediatric Patient With Myopia Phase 3
Recruiting NCT05611294 - Contralateral Study of Topography Guided LASIK Versus Small Incision Lenticule Extraction N/A
Completed NCT05656885 - Clinical Evaluation of Two Frequent Replacement Soft Spherical Contact Lenses N/A
Active, not recruiting NCT05534022 - Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression. N/A
Completed NCT03934788 - the Clinical Performance of the Oxysoft Daily Disposable Silicone Hydrogel Soft Contact Lens N/A
Completed NCT03701516 - Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process 2 N/A
Completed NCT05538754 - Post-Market Evaluation of the EVO ICL N/A
Completed NCT03139201 - Clinical Performance of the OxyAqua Daily Disposable Silicone Hydrogel Soft Contact Lens N/A
Completed NCT02555722 - Evaluation of the CooperVision, Inc. Fanfilcon A and Enfilcon A Daily Wear Contact Lenses When Used for Frequent Replacement for up to One (1) Month of Daily Wear N/A
Not yet recruiting NCT06009458 - Acuity 200™ (Fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear N/A
Recruiting NCT05548478 - Corneal Endothelial Cell Injury Induced by Mitomycin-C N/A