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Tests treatment safety and results for Myopia
Official title The Effectiveness and Safety of Two Low-concentration Atropine Sulfate Eye Drops (0.01%/0.02%) for Delaying the Pediatric Myopia Progression
ClinicalTrials.gov ID: NCT06708156
What this study is testing
What is Atropine sulfate eye drops 0.01%?
Atropine sulfate eye drops 0.01% is an investigational medicine, given as an once-daily, being studied as a potential treatment for myopia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The clinical trial aims to test the effectiveness and safety of two low-dose atropine sulfate eye drops for delaying myopia progression in children and adolescents. Primary Objective: evaluate the effectiveness of 0.01% and 0.02% atropine sulfate eye drops for 96 weeks compared to placebo in delaying myopia progression in children and adolescents.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 12
You may be able to join if
- The legal guardian of the subject voluntarily signed the written informed consent, and the subject over 8 years is required to sign the written...
- Patients with myopia aged 6 to 12 years, including cut-offs.
- The equivalent spherical refraction ranges from -1.00 D to -4.00 D (automatic optometry under a cycloplegia condition) in both myopia eyes at...
- The astigmatism of both eyes was ≤ 1.50 D under a cycloplegia condition at inclusion screening.
- The antimetropia (measured by equivalent spherical refraction) is \< 2.00 D at inclusion screening.
You likely can't join if
- Allergic to this product or its excipients.
- Suffering from eye diseases that may affect vision (e.g. lens diseases such as cataracts, glaucoma, fundus macular disease, keratopathy, uveitis...
- Intraocular pressure of either eye is \> 21 mmHg or \<10 mmHg at screening.
- Use of low-concentration (0.05% and below) atropine sulfate eye drops (including various in-hospital preparations, except for test drugs) and...
- Use of other myopia control methods such as instruments (multifocal glasses, progressive multifocal glasses, etc.), medications (the use of...
- Those who have participated in other clinical trials and received drug or medical device interventions within 3 months before screening.
See the full eligibility criteria
- The legal guardian of the subject voluntarily signed the written informed consent, and the subject over 8 years is required to sign the written informed consent voluntarily.
- Patients with myopia aged 6 to 12 years, including cut-offs.
- The equivalent spherical refraction ranges from -1.00 D to -4.00 D (automatic optometry under a cycloplegia condition) in both myopia eyes at inclusion screening.
- The astigmatism of both eyes was ≤ 1.50 D under a cycloplegia condition at inclusion screening.
- The antimetropia (measured by equivalent spherical refraction) is \< 2.00 D at inclusion screening.
- Able to comply with study requirements, attend all study visits (including telephone visits), and be willing to receive random grouping of atropine treatment or placebo.
- Allergic to this product or its excipients.
- Suffering from eye diseases that may affect vision (e.g. lens diseases such as cataracts, glaucoma, fundus macular disease, keratopathy, uveitis, retinal detachment, severe vitreous opacity, etc., manifest strabismus...
- Intraocular pressure of either eye is \> 21 mmHg or \<10 mmHg at screening.
- Use of low-concentration (0.05% and below) atropine sulfate eye drops (including various in-hospital preparations, except for test drugs) and orthokeratology lenses (OK lenses) within 6 months before the screening.
- Use of other myopia control methods such as instruments (multifocal glasses, progressive multifocal glasses, etc.), medications (the use of cycloplegic agents for examinations such as optometry is allowed), and others...
- Those who have participated in other clinical trials and received drug or medical device interventions within 3 months before screening.
- Systemic or topical use of drugs that affect the how well it works evaluation, such as anticholinergics: atropine, pirenzepine, etc., and cholinomimetics: pilocarpine, etc. within 1 week before screening.
- Combined with severe immune system disease, central nervous system disease, Down syndrome, asthma, cardiopulmonary insufficiency, liver and kidney dysfunction, etc.
- Surgical intervention (ocular or systemic) within 6 months before screening, or planned surgery during the study.
- Heart rate sustained (more than 10 minutes) greater than 120 beats/min at screening (after 10 minutes of rest if the ECG shows a heart rate greater than 120 beats per minute, the ECG should be retested 10 minutes later...
- Need for ocular use or systemic oral corticosteroids during the study. Intranasal, inhaled, topical cutaneous, intra-articular, perianal steroids, and short-term oral steroids (i.e., continuous use for \< 2 weeks).
- Other conditions that are considered unsuitable by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Xuancheng, Anhui, China
- Lanzhou, Gansu, China
- Liuzhou, Guangxi, China
- Nanning, Guangxi, China
- Guiyang, Guizhou, China
- Zunyi, Guizhou, China
- Daqing, Heilongjiang, China
- Kaifeng, Henan, China
- Hengyang, Hunan, China
- Huai'an, Jiangsu, China
- Nanchang, Jiangxi, China
- Weifang, Shandong, China
- Changzhi, Shanxi, China
- Taiyuan, Shanxi, China
- Xianyang, Shanxi, China
- Hangzhou, Zhejiang, China
- Beijing, China
- Chongqing, China
- Shanghai, China
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 12 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Xuancheng, Anhui, China; Lanzhou, Gansu, China; Liuzhou, Guangxi, China; Nanning, Guangxi, China; Guiyang, Guizhou, China and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.