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AzTrials

MyopiaPhase 1NCT03699423

Effects of Low Concentration Atropine on Pupillary Size and Accommodative Amplitude

A Phase 1 study testing 0.01% atropine eye drops, 0.02% atropine eye drops and 0.03% atropine eye drops in people with Myopia, run by Hai Yen Eye Care at 1 site in Vietnam.

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

To assess the two-week ocular responses, especially on pupillary size and accommodative amplitude, of nightly application of 0.01% or 0.02% or 0.03% atropine eye drops in children with myopia who were randomized to use of three different low-concentration atropine eye drops Read more about this study

Who is it for?
Ages 6 to 12 years
Conditions the study is for
Myopia
What is being tested?
0.01% atropine eye drops, 0.02% atropine eye drops and 0.03% atropine eye drops
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteVietnam
Study dates
8 Mar 2018to 30 Apr 2018
Phase
Phase 1
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

  • Able to read and comprehend Vietnamese and having parents or legal guardians who give informed consent as demonstrated by signing a record of informed consent.
  • Be between 6 and 12 years old, male or female.
  • Willing to apply eye drops once nightly at bedtime for two weeks and follow the clinical trial visit schedule as directed by the Investigator.
  • Willing to answer the questionnaire about subjective measurements
  • Have ocular findings deemed to be normal
  • No contact lens wearing history
  • Vision correctable to at least 20/25 or better in each eye with spectacles

Who cannot join

  • Any pre-existing ocular irritation, injury or condition, including infection or disease.
  • Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants.
  • Use of or a need for concurrent category S3 and above ocular medication at enrolment and/or during the clinical trial.
  • Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant's ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and/or during the clinical trial.
  • NB: Systemic antihistamines are allowed on an "as needed basis", provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used.
  • History of eye surgery
Show all 11Show fewer
  • History of use of any myopia control interventions such as Orthokeratology, Rigid Permeable Contact Lenses Eye surgery within 12 weeks immediately prior to enrolment for this trial.
  • Currently treated with other interventions for myopia control
  • Contraindications to atropine such as pulmonary disease, heart conditions and ADHD
  • Known allergy or intolerance to ingredients to atropine eye-drops and other derivatives of anti-muscarinic receptor agents.
  • Currently enrolled in another clinical trial.

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

  • Department of Ophthalmology - An Sinh Hospital

    Ho Chi Minh City, 700000

Other trials in Vietnam

About this study

Official title: Evaluation of Two-week Effects of 0.01%, 0.02% and 0.03% Atropine Eye Drops on Children Eyes With Myopia

To assess the two-week ocular responses, especially on pupillary size and accommodative amplitude, of nightly application of 0.01% or 0.02% or 0.03% atropine eye drops in children with myopia who were randomized to use of three different low-concentration atropine eye drops

Read the detailed description

Atropine was proven to be effective in controlling myopia progression. However, the most common side effects of the use of atropine eye drop are dilation of pupil and decrease of accommodation. The investigators wish to evaluate the ocular responses of three low concentration atropine eye drops, 0.01% or 0.02% or 0.03%, mainly on the pupillary size and accommodative responses in children aged between 6 to 12 years old over two-week usage.

Conditions
Myopia
Being tested
0.01% atropine eye drops, 0.02% atropine eye drops, 0.03% atropine eye drops
Keywords
myopia control, low concentration atropine eye drops, anti-muscarinic receptors, pupil size, accommodative amplitude
Medical subject headings
Myopia

What participants receive

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

  • 0.01% atropine eye dropsDrug

    0.01% atropine sulphate

  • 0.02% atropine eye dropsDrug

    0.02% atropine sulphate

  • 0.03% atropine eye dropsDrug

    0.03% atropine sulphate

Study groups in NCT03699423
Study groupRoleWhat they receive
0.01% atropine eye dropsActive comparatorParticipants will receive one drop per eye every night for two weeks
Receives: Drug: 0.01% atropine eye drops
0.02% atropine eye dropsActive comparatorParticipants will receive one drop per eye every night for two weeks
Receives: Drug: 0.02% atropine eye drops
0.03% atropine eye dropsActive comparatorParticipants will receive one drop per eye every night for two weeks
Receives: Drug: 0.03% atropine eye drops

What is being measured

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

  1. Change in pupillary diameter

    Measure and compare the photopic and mesopic pupil size (milimeters) before and after instillation of eye drops

    Measured: at baseline, at three day and at two week

  2. Change in accommodative amplitude

    Measure and compare the accommodative amplitude (diopters) before and after instillation of eye drops

    Measured: at baseline, at three day and at two week

Timeline

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

  1. First posted9 Oct 2018
  2. Study start8 Mar 2018
  3. Primary completion30 Apr 2018
  4. Study completion30 Apr 2018

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 1
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03699423
Sponsor's protocol ID
CS_AS_18_07
Status last verified
Oct 2018
First submitted
5 Oct 2018
Last updated
9 Oct 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016/j.ophtha.2016.01.006. Epub 2016 Feb 11.

    PubMed 26875007

  • Sankaridurg PR, Holden BA. Practical applications to modify and control the development of ametropia. Eye (Lond). 2014 Feb;28(2):134-41. doi: 10.1038/eye.2013.255. Epub 2013 Dec 6.

    PubMed 24310242

  • Huang J, Wen D, Wang Q, McAlinden C, Flitcroft I, Chen H, Saw SM, Chen H, Bao F, Zhao Y, Hu L, Li X, Gao R, Lu W, Du Y, Jinag Z, Yu A, Lian H, Jiang Q, Yu Y, Qu J. Efficacy Comparison of 16 Interventions for Myopia Control in Children: A Network Meta-analysis. Ophthalmology. 2016 Apr;123(4):697-708. doi: 10.1016/j.ophtha.2015.11.010. Epub 2016 Jan 27.

    PubMed 26826749

  • Polling JR, Kok RG, Tideman JW, Meskat B, Klaver CC. Effectiveness study of atropine for progressive myopia in Europeans. Eye (Lond). 2016 Jul;30(7):998-1004. doi: 10.1038/eye.2016.78. Epub 2016 Apr 22.

    PubMed 27101751

  • Chia A, Lu QS, Tan D. Five-Year Clinical Trial on Atropine for the Treatment of Myopia 2: Myopia Control with Atropine 0.01% Eyedrops. Ophthalmology. 2016 Feb;123(2):391-399. doi: 10.1016/j.ophtha.2015.07.004. Epub 2015 Aug 11.

    PubMed 26271839

  • Cooper J, Eisenberg N, Schulman E, Wang FM. Maximum atropine dose without clinical signs or symptoms. Optom Vis Sci. 2013 Dec;90(12):1467-72. doi: 10.1097/OPX.0000000000000037.

    PubMed 24076540

  • Tran HDM, Ha TTX, Tran YH, Coroneo M, Tran TD, Truong TU, Sankaridurg P. Impact of Various Concentrations of Low-Dose Atropine on Pupillary Diameter and Accommodative Amplitude in Children with Myopia. J Ocul Pharmacol Ther. 2024 May;40(4):232-239. doi: 10.1089/jop.2023.0173. Epub 2024 Apr 15.

    PubMed 38621178

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 0.01% atropine eye drops, 0.02% atropine eye drops and 0.03% atropine eye drops in people with Myopia, run by Hai Yen Eye Care at 1 site in Vietnam.

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 11 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 9 Oct 2018. 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 Vietnam. 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 phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 pupillary diameter (time frame: at baseline, at three day and at two week). The study lists 2 primary outcomes in all. 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 NCT03699423, which also lists 7 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 9 Oct 2018.

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