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MyopiaPhase 2/3NCT00371124

Safety and Efficacy Study of 0.5%, 0.1% & 0.01% Atropine Treatment to Both Eyes In Treatment of Myopia In Children

A Phase 2/3 study testing Atropine Eye drops in people with Myopia, run by Singapore National Eye Centre at 1 site in Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to find an optimal dose of atropine for preventing the rapid progression of myopia in children by comparing the efficacy, safety and functional impact of binocular treatment with 0.5%, 0.1% and 0.01% atropine and to develop a treatment regimen for the routine management of childhood myopia. Read more about this study

Who is it for?
Ages 6 to 12 years
Conditions the study is for
Myopia
What is being tested?
Atropine Eye drops
How many people
400 participants
Where
1 siteSingapore
Study dates
Mar 2006to not given
Phase
Phase 2/3
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 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Written Informed Consent from parent and assent from child has been obtained
  • Children aged 6 to 12 years
  • Refractive error of spherical equivalent -2.00 D or worse in each eye as measured by cycloplegic autorefraction
  • Active myopia progression of at least spherical equivalent -0.50 D over the last 12 months as determined or suggested by refractive records or change in lens power
  • Astigmatism of less than or equal to -1.50 D as measured by cycloplegic or non-cycloplegic autorefraction
  • Distance vision correctable to logMAR 0.2 or better in both eyes
Show all 13Show fewer
  • A difference between non-cycloplegic subjective spherical refraction and cycloplegic subjective spherical refraction of not greater than -1.00 D
  • Normal intraocular pressure of not greater than 21 mmHg
  • Normal ocular health other than myopia
  • In good general health with no history of cardiac or significant respiratory diseases
  • No asthma-requiring medications in the past one year
  • No allergy to atropine, cyclopentolate, proparacaine and benzalkonium chloride
  • Willing and able to comply with scheduled visits and other study procedures

Who cannot join

  • Ocular or systemic diseases which may affect vision or refractive error
  • Any ocular condition wherein topical atropine is contraindicated
  • Defective binocular function or stereopsis
  • Amblyopia or manifest strabismus including intermittent tropia
  • Previous or current use of atropine or pirenzepine
  • Any other conditions precluding adherence to the protocol including unwillingness to refrain from contact lens wear for the duration of the study

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • Singapore Eye Research Institute

    Singapore

Other trials in Singapore

About this study

Official title: A Randomised, Double-Masked Study to Compare The Safety and Efficacy of Bilateral 0.5%, 0.1% & 0.01% Atropine Treatment In Controlling Progression of Myopia In Children

The purpose of this study is to find an optimal dose of atropine for preventing the rapid progression of myopia in children by comparing the efficacy, safety and functional impact of binocular treatment with 0.5%, 0.1% and 0.01% atropine and to develop a treatment regimen for the routine management of childhood myopia.

Read the detailed description

A Randomised, Double-Masked Study to Compare The Safety and Efficacy of Bilateral 0.5%, 0.1% \& 0.01% Atropine Treatment In Controlling Progression of Myopia In Children

Study Duration and Visit Schedule Total of 5 years with 15 scheduled visits.

  1. Phase I: 2 years with 8 scheduled visits
  2. Phase II: 3 years with 7 scheduled visits

STUDY DESIGN This study consists of 2 phases, each with a different design. Phase I is a double-masked single-centre clinical trial wherein 400 children aged 6-12 years, with myopia of -2.00 D or worse in each eye, and from whom assent and parental/guardian consent have been obtained, will be randomised to receive 0.5% atropine, 0.1% atropine or 0.01% atropine once nightly in both eyes. Participants will be assigned to treatment in the ratio of 2:2:1, respectively. Each child will receive treatment for a period of 2 years during which they will be reviewed every 4 months.

Phase II is an open-label study wherein all children will continue to be followed-up regularly for changes in their refractive error after stopping atropine treatment. Those children who demonstrate myopia progression of -0.5 D or more, at least on one eye after a minimum of 8 months washout period will restart atropine treatment in both eyes. The appropriate dose will be determined by analysis of the data from Phase I of the study. Treatment will be for a further 2 years and all children, including those not receiving treatment, will be reviewed every 6 months.

Conditions
Myopia
Being tested
Atropine Eye drops
Keywords
Myopia treatment, 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 Eye dropsDrug

What is being measured

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

  1. Spherical equivalent refraction determined by cycloplegic autorefraction

Secondary outcomes (7)

  1. Axial length determined by non-contact partial coherence interferometry

  2. Ocular symptoms

  3. Induced cycloplegia assessed by near acuity and amplitude of accommodation tests

  4. Pupil reactivity and diameter assessment

  5. Ocular surface and anterior segment changes assessed by slit-lamp and intraocular pressure assessed by non-contact tonometry

  6. Posterior segment changes assessed by fundus photography and ophthalmoscopy

  7. Retinal function assessed by distance acuity test and electroretinography

Timeline

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

  1. First posted1 Sep 2006 (estimated)
  2. Study startMar 2006

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00371124
Sponsor's protocol ID
R359/17/2004
Status last verified
May 2010
First submitted
30 Aug 2006
Last updated
31 Aug 2010
Results posted
No

Publications

  • Chua WH, Balakrishnan V, Tan D, Chan YH, ATOM Study Group. Efficacy results from the atropine in the treatment of myopia (ATOM) study. Invest Ophthalmol Vis Sci 2003;44:E-Abstract 3119.

  • Chua WH, Balakrishnan V, Chan YH, ATOM Study Group. Analysis of the safety data from the atropine in the treatment of myopia (ATOM) study. Invest Ophthalmol Vis Sci 2002;43:E-Abstract 3329.

  • McBrien NA, Moghaddam HO, Reeder AP. Atropine reduces experimental myopia and eye enlargement via a nonaccommodative mechanism. Invest Ophthalmol Vis Sci. 1993 Jan;34(1):205-15.

    PubMed 8425826

  • Shih YF, Hsiao CK, Chen CJ, Chang CW, Hung PT, Lin LL. An intervention trial on efficacy of atropine and multi-focal glasses in controlling myopic progression. Acta Ophthalmol Scand. 2001 Jun;79(3):233-6. doi: 10.1034/j.1600-0420.2001.790304.x.

    PubMed 11401629

  • Shih YF, Chen CH, Chou AC, Ho TC, Lin LL, Hung PT. Effects of different concentrations of atropine on controlling myopia in myopic children. J Ocul Pharmacol Ther. 1999 Feb;15(1):85-90. doi: 10.1089/jop.1999.15.85.

    PubMed 10048351

  • Bedrossian RH. The effect of atropine on myopia. Ophthalmology. 1979 May;86(5):713-9. doi: 10.1016/s0161-6420(79)35455-0.

    PubMed 545205

  • Lee JJ, Fang PC, Yang IH, Chen CH, Lin PW, Lin SA, Kuo HK, Wu PC. Prevention of myopia progression with 0.05% atropine solution. J Ocul Pharmacol Ther. 2006 Feb;22(1):41-6. doi: 10.1089/jop.2006.22.41.

    PubMed 16503774

  • Lawrenson JG, Shah R, Huntjens B, Downie LE, Virgili G, Dhakal R, Verkicharla PK, Li D, Mavi S, Kernohan A, Li T, Walline JJ. Interventions for myopia control in children: a living systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 16;2(2):CD014758. doi: 10.1002/14651858.CD014758.pub2.

    PubMed 36809645

  • Kumaran A, Htoon HM, Tan D, Chia A. Analysis of Changes in Refraction and Biometry of Atropine- and Placebo-Treated Eyes. Invest Ophthalmol Vis Sci. 2015 Aug;56(9):5650-5. doi: 10.1167/iovs.14-14716.

    PubMed 26313301

  • Chia A, Chua WH, Wen L, Fong A, Goon YY, Tan D. Atropine for the treatment of childhood myopia: changes after stopping atropine 0.01%, 0.1% and 0.5%. Am J Ophthalmol. 2014 Feb;157(2):451-457.e1. doi: 10.1016/j.ajo.2013.09.020. Epub 2013 Dec 4.

    PubMed 24315293

  • Chia A, Li W, Tan D, Luu CD. Full-field electroretinogram findings in children in the atropine treatment for myopia (ATOM2) study. Doc Ophthalmol. 2013 Jun;126(3):177-86. doi: 10.1007/s10633-012-9372-8. Epub 2013 Jan 5.

    PubMed 23292524

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Atropine Eye drops in people with Myopia, run by Singapore National Eye Centre at 1 site in Singapore.

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 13 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 31 Aug 2010. 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 Singapore. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Results are not available in the source record.

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?

Spherical equivalent refraction determined by cycloplegic autorefraction. 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 NCT00371124, which also lists 11 linked publications.

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 31 Aug 2010.

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