Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06209281
Other study ID # ZKO-ATP-202105-Mini-CHAMP
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date May 13, 2022
Est. completion date August 2024

Study information

Verified date January 2024
Source Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 526
Est. completion date August 2024
Est. primary completion date August 20, 2023
Accepts healthy volunteers No
Gender All
Age group 6 Years to 10 Years
Eligibility Inclusion Criteria: 1. Child (female or male) aged 6 to 10 years. 2. Myopia (SER of at least -0.50 D and no more myopic than -6.00 D) in each eye as measured by cycloplegic autorefraction. 3. If present, astigmatism of =1.50 D in each eye as measured by cycloplegic autorefraction. 4. Anisometropia SER of < 1.50 D as measured by cycloplegic autorefraction. Exclusion Criteria: 1. History of any disease or syndrome that predisposed the subject to severe myopia (e.g.,Marfan syndrome, Stickler syndrome, retinopathy of prematurity). 2. History in either eye of abnormal ocular refractive anatomy (e.g., keratoconus, lenticonus,spherophakia). 3. Chronic use of any topical or systemic antimuscarinic/anticholinergic medications (e.g.,atropine, scopolamine, tropicamide) within 21 days prior to screening and/or anticipated need for chronic use during the study period (i.e., more than 7 consecutive days in 1 month or more than 30 total days in 1 year). Use of cycloplegic drops for dilated ocular exam was allowable. 4. Heart rate persistently (for more than 10 minutes) > 120 beats per minute. 5. Allergy to study drugs.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lower dose atropine sulfate eye drops
Administer to eyes
Low dose atropine sulfate eye drops
Administer to eyes
placebo
Administer to eyes

Locations

Country Name City State
China Eye & ENT Hospital of Fudan University Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Axial Length Between-group difference in the mean change from baseline in axial length at visit M12 twelve months
Other Crystalline Lens Thickness Between-group difference in the mean change from baseline in crystalline lens thickness at visit M12 twelve months
Primary Cycloplegic Autorefraction(low) Group difference in the proportion of subjects eyes with myopia progression (SER) less than -0.50 D at M12 visit with low atropine versus placebo. twelve months
Secondary Cycloplegic Autorefraction(lower) Group difference in the proportion of subjects eyes with myopia progression (SER) less than -0.50 D at M12 visit with lower atropine versus placebo. twelve months
Secondary Cycloplegic Autorefraction(SER) Between-group difference in the mean change from baseline in SER at visit M12 twelve months
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