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MyopiaPhase 3NCT06708156

The Effectiveness and Safety of Two Low-concentration Atropine Sulfate Eye Drops (0.01%/0.02%) for Delaying the Pediatric Myopia Progression

A Phase 3 study testing Atropine sulfate eye drops 0.01% and Atropine sulfate eye drops 0.02% in people with Myopia and Myopia Progression, run by Oupushifang Pharmaceutical Technology Co., Ltd. at 25 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 6 to 12 years
Conditions the study is for
Myopia, Myopia Progression
What is being tested?
Atropine sulfate eye drops 0.01% and Atropine sulfate eye drops 0.02%
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
606 participants
Where
25 sitesChina
Study dates
15 Jun 2024to 31 Dec 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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, nystagmus, ocular acute inflammatory disease), history of recurrent chronic ocular inflammation, or any other ocular pathology (e.g., angular stenosis, shallow anterior chamber).
  • 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 (including traditional Chinese medicine, auricular acupuncture, massage, accommodative flippers, red light therapy instrument, etc.) within 3 months before screening.
  • Those who have participated in other clinical trials and received drug or medical device interventions within 3 months before screening.
Show all 12Show fewer
  • Systemic or topical use of drugs that affect the efficacy 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. If the retest result below 120 beats/min, the screening is successful; If the retest result is still >120 beats/min, screening failed).
  • 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.

Trial locations and contacts

25 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Liang Gao contact

0086-15056564539

9071044822@qq.com

Shaolong XUE, Dr. contact

0086-18565027687

xuesl@seefunge.com

25 sites in 1 country

China25 sites, 25 recruiting

  • Beijing Tongren Hospital Affiliated to Capital Medical University

    Beijing

    Feng Wu, 0086-15910961255, bjtrec@126.com

    Ningli Wang, Postdoctoral

    Recruiting

  • Peking University Third Hospital

    Beijing

    Yueguo Chen

    Recruiting

  • Heping Hospital Affiliated to Changzhi Medical College

    Changzhi, Shanxi

    Yun Cui

    Recruiting

  • Chongqing Aier Eye Hospital

    Chongqing

    Yi Ren

    Recruiting

  • Daqingshi People's Hospital

    Daqing, Heilongjiang

    Xingmin Wang

    Recruiting

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou

    Hao Gu

    Recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang

    Lijun Shen

    Recruiting

  • Hefei Maternal and Child Health Hospital

    Hefei, Anhui

    Ruqin Zha

    Recruiting

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui

    Liming Tao

    Recruiting

  • The First Affiliated Hospital of University of South China

    Hengyang, Hunan

    Gang Tan

    Recruiting

  • Huai'an First People's Hospital

    Huai'an, Jiangsu

    Chaopeng Li

    Recruiting

  • Kaifeng Central Hospital

    Kaifeng, Henan

    Hongmei Mu

    Recruiting

  • The Second Hospital of Lanzhou University

    Lanzhou, Gansu

    Wanna Ren

    Recruiting

  • Liuzhou People's Hospital

    Liuzhou, Guangxi

    Xiaobo Wan

    Recruiting

  • Affiliated Eye Hospital of Nanchang University

    Nanchang, Jiangxi

    Hongfei Liao

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

    Xiaorong Wu

    Recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

    Xiaolong Yin

    Recruiting

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi

    Qi Chen

    Recruiting

  • Shanghai Eye Disease Prevention and Treatment Center (Shanghai Eye Hospital)

    Shanghai

    Haidong Zou

    Wei Xu

    Recruiting

  • Shanxi Eye Hospital

    Taiyuan, Shanxi

    Junhong Li

    Recruiting

  • Tianjin Medical University Eye Hospital

    Tianjin

    Lin Liu

    Recruiting

  • Weifang Eye Hospital

    Weifang, Shandong

    Xianyong Sun

    Recruiting

  • Xianyang Hospital of Yan'an University

    Xianyang, Shanxi

    Binke Yu

    Recruiting

  • Xuancheng People's Hospital

    Xuancheng, Anhui

    Shenghua Dong

    Recruiting

  • The First People's Hospital of Zunyi

    Zunyi, Guizhou

    Wei Tan

    Recruiting

Other trials in China

About this study

Official title: The Effectiveness and Safety of Two Low-concentration Atropine Sulfate Eye Drops (0.01%/0.02%) for Delaying the Progression of Myopia in Children and Adolescents in a Randomized, Double-blind, Placebo Parallel-controlled, Multicenter, Phase III Clinical Trial

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. Secondary Objective: evaluate the safety of two low-concentration atropine sulfate eye drops (0.01%/0.02%) in delaying myopia progression in children and adolescents.

Read more

Exploratory Objective:

  1. the efficacy and safety of two low-concentration atropine sulfate eye drops (0.01%/0.02%) for 144 weeks.
  2. evaluate the rebound effect of two low-concentration atropine sulfate eye drops (0.01%/0.02%) after discontinuation.
Being tested
Atropine sulfate eye drops 0.01%, Atropine sulfate eye drops 0.02%, Placebo eye drops
Keywords
Myopia, Atropine
Medical subject headings
Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atropine sulfate eye drops 0.01%Drug

    Drug: 0.01% atropine sulfate eye drops Dosage form and strength: 0.01% (0.4 mL: 0.04 mg) eye drops Usage: both eyes, 1 drop in each eye, once a day, every night before sleep, gently press the dacryocyst on both sides for about 1 minute.

  • Atropine sulfate eye drops 0.02%Drug

    Drug: 0.02% atropine sulfate eye drops Dosage form and strength: 0.02% (0.4 mL: 0.08 mg) eye drops Usage: both eyes, 1 drop in each eye, once a day, every night before sleep, gently press the dacryocyst on both sides for about 1 minute.

  • Placebo eye dropsDrug

    Drug: placebo eye drops Dosage form and strength: 0.4 mL eye drops Usage: both eyes, 1 drop in each eye, once a day, every night before sleep, gently press the dacryocyst on both sides for about 1 minute.

Study groups in NCT06708156
Study groupRoleWhat they receive
Experimental group (0.01% atropine sulfate eye drops)Active comparator1 drop in each eye, once a day, every night before sleep, gently press the dacryocyst on both sides for about 1 minute.
Receives: Drug: Atropine sulfate eye drops 0.01%
Experimental group (0.02% atropine sulfate eye drops)Active comparator1 drop in each eye, once a day, every night before sleep, gently press the dacryocyst on both sides for about 1 minute.
Receives: Drug: Atropine sulfate eye drops 0.02%
Control group (placebo eye drops)Placebo comparator1 drop in each eye, once a day, every night before sleep, gently press the dacryocyst on both sides for about 1 minute.
Receives: Drug: Placebo eye drops

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effective change from baseline in equivalent spherical refraction at Week 96 visit

    The inter-group difference in the value of change from baseline in equivalent spherical refraction after 0.01% or 0.02% atropine sulfate eye drops versus placebo under a cycloplegia condition at the Week 96 visit

    Measured: At the Week 96 visit

Secondary outcomes (9)

  1. Effective change from baseline in eye axis length at 24 months

    Value of change from baseline in eye axis length at 24 months of dosing (0.02% atropine vs. placebo; 0.01% atropine vs. placebo)

    Measured: At the Week 96 visit

  2. Effective change from baseline in refraction at 12 months

    Change from baseline in refraction (automatic optometric equivalent spherical refraction under a cycloplegia condition) at 12 months (0.02% atropine vs. placebo; 0.01% atropine vs. placebo)

    Measured: At the Week 48 visit

  3. Effective change from baseline in ocular axis length at 12 months

    Change from baseline in ocular axis length at 12 months of dosing (0.02% atropine vs. placebo; 0.01% atropine vs. placebo)

    Measured: At the Week 48 visit

  4. Progression of refraction ≤0.50 D at 12 months and 24 months and percentage

    Progression of refraction (automatic optometric equivalent spherical refraction under a cycloplegia condition) ≤0.50 D at 12 months and 24 months (0.02% atropine vs. placebo; 0.01% atropine vs. placebo) and percentage (0.02% atropine vs. placebo; 0.01% atropine vs. placebo)

    Measured: At the Week 48 and Week 96 visits

  5. Progression of refraction ≤0.75D at 12 months and 24 months and percentage

    Progression of refraction (automatic optometric equivalent spherical refraction under a cycloplegia condition) ≤0.75D at 12 months and 24 months and percentage (0.02% atropine vs placebo; 0.01% atropine vs placebo)

    Measured: At the Week 48 and Week 96 visits

  6. Progression of refraction ≤1.00D at 12 months and 24 months and percentage

    Progression of refraction (automatic optometric equivalent spherical refraction under a cycloplegia condition) ≤1.00D at 12 months and 24 months (0.02% atropine vs. placebo; 0.01% atropine vs. placebo) and percentage (0.02% atropine vs. placebo; 0.01% atropine vs. placebo)

    Measured: At the Week 48 and Week 96 visits

  7. Progression of refraction >1.00D at 12 months and 24 months and percentage

    Progression of refraction (automatic optometric equivalent spherical refraction under a cycloplegia condition) >1.00D at 12 months and 24 months of dosing and percentage (0.02% atropine vs. placebo; 0.01% atropine vs. placebo)

    Measured: At the Week 48 and Week 96 visits

  8. Percentage of patients with 30% and 50% reduction in myopia progression at 12 and 24 months

    Percentage of patients with 30% and 50% reduction in myopia progression at 12 and 24 months of medication compared to control (0.02% atropine versus placebo; 0.01% atropine versus placebo)

    Measured: At the Week 48 and Week 96 visits

  9. Change from baseline in other ocular morphologic measures at 12 months and 24 months

    Change from baseline in other ocular morphologic measures (e.g., corneal curvature, vitreous chamber depth, choroidal thickness) at 12 months and 24 months of dosing (0.02% atropine vs. placebo; 0.01% atropine vs. placebo)

    Measured: At the Week 48 and Week 96 visits

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2024
  2. Study start15 Jun 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
606 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06708156
Sponsor's protocol ID
CTR20240786
Other IDs
CTR20240786
Status last verified
Dec 2024
First submitted
20 Nov 2024
Last updated
24 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atropine sulfate eye drops 0.01% and Atropine sulfate eye drops 0.02% in people with Myopia and Myopia Progression, run by Oupushifang Pharmaceutical Technology Co., Ltd. at 25 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Liang Gao (0086-15056564539, 9071044822@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effective change from baseline in equivalent spherical refraction at Week 96 visit (time frame: At the Week 96 visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06708156.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.

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