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MyopiaPhase 3NCT06697522

Study of Atropine Sulfate Eye Drops(0.01%) in Treating Near-work-induced Transient Myopia in Children

A Phase 3 study testing Atropine Sulfate in people with Myopia, run by Ocumension Therapeutics (Suzhou) Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of atropine sulfate eye drops (0.01%) in treating transient myopia induced by near work tasks (NITM) in pediatric subjects. Read more about this study

Who is it for?
Ages 6 to 15 years
Conditions the study is for
Myopia
What is being tested?
Atropine Sulfate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
148 participants
Where
1 siteChina
Study dates
25 Jun 2023to 26 Mar 2024
Phase
Phase 3
Are there results?
None posted in the registry

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 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • For subjects of age between 6 to 8, their parents or legal guardians must provide written informed consent; For 8 year old subjects and above, both the subjects and their legal guardians need to sign the informed consent form.
  • They must be able to comply with the research requirements, attend all study visits, and be accompanied by their parents/legal guardians.
  • The age range during the screening period (from Day -14 to Day 0) is 6-15 years, with no gender restrictions.
  • The optometry results during the screening period should show: a) Myopia between -0.50DS and -4.00DS. b) Astigmatism ≤1.50DC, and less than half of the spherical lens power. c) The initial NITM value (equivalent sphere) for either eye should be ≤-0.40D.
  • The difference in refractive error between both eyes during the screening period should be ≤1.00D in equivalent spherical lens power.
  • The best corrected visual acuity (BCVA) for both eyes during the screening period should be ≥0.8 on the standard logarithmic visual acuity chart.
  • They must be able and willing to avoid using all prohibited medications during the washout period between screening and randomization, as well as during the study period, with no significant risk to the subjects.

Who cannot join

  • Known contraindications or allergies to atropine sulfate, the study drug, or its components.
  • Clinically significant abnormal findings on slit-lamp microscopy examination (e.g., cataract) that may affect the measurement of best-corrected visual acuity in either eye at the time of screening, or known clinically significant findings from a previous slit-lamp microscopy examination in either eye.
  • Clinically significant abnormal findings on direct ophthalmoscopy at the time of screening in either eye, or known previous clinically significant retinal findings in either eye.
  • Evidence of any ocular motility disorder or restriction of extraocular muscle movement (e.g., nystagmus).
  • Presence of infectious eye diseases (such as bacterial, viral, or fungal infections).
  • Active ocular inflammation in either eye or a history of chronic or recurrent ocular inflammation (e.g., moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis).
Show all 21Show fewer
  • History of ocular herpes virus infection, iritis, scleritis, or uveitis, regardless of whether it is active at the time of screening.
  • Abnormal pupillary light reflex and/or amblyopia at the time of screening.
  • Intraocular pressure (IOP) in either eye <9mmHg or >21mmHg at the time of screening, or a difference in IOP between both eyes ≥5mmHg, or a previous diagnosis of ocular hypertension or glaucoma, or currently receiving any type of topical IOP-lowering (glaucoma) medication.
  • Received surgical intervention (ocular or systemic) within 6 months prior to the screening period, or planning to receive surgical intervention during the study period.
  • Use of any prohibited medication or treatment (ocular or periocular topical medication, systemic medication, injectable medication, and use of any lenses that can slow the progression of myopia) during the specified period before Visit 1. These medications or treatments are also prohibited during the study period. The shortest reasonable washout period for prohibited medications or treatments is:
  • Any prescription or over-the-counter ophthalmic product (3 days); artificial tears are allowed, but not within 2 hours after the administration of the study drug.
  • Monoamine oxidase inhibitors (7 days).
  • Atropine, pirenzepine, or other anticholinergic drugs (60 days).
  • Any medication affecting the pupil or accommodation (60 days).
  • Orthokeratology (OK) lenses, rigid gas-permeable contact lenses, bifocal contact lenses, progressive multifocal lenses, multifocal contact lenses, or other lenses that can slow the progression of myopia (90 days).
  • Monocular glasses and/or monofocal hydrophilic soft contact lenses for myopia correction can be normally used during the study period.
  • Expected use of ocular or systemic oral corticosteroids during the study period.
  • Participation in any other experimental treatment study within 30 days before the screening period or during the study period.
  • History or current disease that makes the subject prone to secondary myopia (e.g., Marfan syndrome, Stickler syndrome) or may affect visual function or development (e.g., diabetes, chromosomal abnormalities).
  • Presence of any condition or situation that the investigator believes may increase the risk to the subject, confound study data, or severely interfere with the subject's participation in the study, including but not limited to unstable: cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immune, skin, hematological, neurological, or psychiatric diseases.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Children's Hospital, Capital Medical University

    Beijing

Other trials in China

About this study

Official title: A Randomized, Double-masked, Placebo-controlled, Parallel-group Study of Safety and Efficacy of Atropine Sulfate Eye Drops (0.01%) in the Treatment of Near-work-induced Transient Myopia (NITM) in Children

This study is a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of atropine sulfate eye drops (0.01%) in treating transient myopia induced by near work tasks (NITM) in pediatric subjects.

Read the detailed description

All eligible subjects will be randomly assigned in a 1:1 ratio to either the 0.01% atropine sulfate eye drops group or the atropine sulfate eye drops vehicle placebo control group. Subjects in the treatment group will apply one drop of 0.01% atropine sulfate eye drops to each eye before going to bed at night, while subjects in the control group will apply one drop of the atropine sulfate eye drops vehicle placebo to each eye before going to bed at night. All eligible subjects will be randomly grouped and receive treatment for a period of 12 weeks. All subjects will be followed up according to the same timing and examination schedule. The follow-up time points will be on the 1st day, 14th day, and 12th week after administration, as well as 12 weeks after discontinuation of the medication.

Conditions
Myopia
Being tested
Atropine Sulfate, Placebo
Keywords
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 SulfateDrug

    Also called Investigational product

    low concentration atropine (0.01%)

  • PlaceboDrug

    Also called Blank Solvent

    Blank comparator

Study groups in NCT06697522
Study groupRoleWhat they receive
0.01% AtropineExperimentalAtropine Sulfate Eye Drops, conc. 0.01%
Receives: Drug: Atropine Sulfate
Blank SolventPlacebo comparatorBlank solvent placebo
Receives: Drug: Placebo

What is being measured

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

  1. Change in initial NITM (Nearwork-induced transient myopia) values from baseline to week 12.

    Compare the autorefractor NITM results measured in week 12 of the experimental and control group.

    Measured: DAY 1 & Week 12

Secondary outcomes (5)

  1. Change from baseline in initial NITM values at week 2 and week 24

    Measure the initial NITM (Near-Induced Transient Myopia) values at the designed time point.

    Measured: Week 2 and week 24

  2. Initial NITM values

    Test the initial NITM (Near-Induced Transient Myopia) at each time point.

    Measured: Week 2

  3. Initial NITM values

    Test the initial NITM (Near-Induced Transient Myopia) at each time point.

    Measured: Week 12

  4. Initial NITM values

    Test the initial NITM (Near-Induced Transient Myopia) at each time point.

    Measured: Week 24

  5. The difference between the change in initial NITM values

    The difference between the change in initial NITM values from baseline to week 12 and the change from baseline to week 24

    Measured: Day 1 & Week 12 & Week 24

Timeline

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

  1. First posted20 Nov 2024
  2. Study start25 Jun 2023
  3. Primary completion6 Oct 2023
  4. Study completion26 Mar 2024

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
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
148 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06697522
Sponsor's protocol ID
Protocol V 7.0
Status last verified
Nov 2024
First submitted
18 Nov 2024
Last updated
20 Nov 2024
Results posted
No
Data monitoring committee
No
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 in people with Myopia, run by Ocumension Therapeutics (Suzhou) Co., Ltd at 1 site 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 7 inclusion and 21 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: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in initial NITM (Nearwork-induced transient myopia) values from baseline to week 12. (time frame: DAY 1 & Week 12). 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 NCT06697522.

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 20 Nov 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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