MyopiaNCT03374306

Topical Application of Low-concentration (0.01%) Atropine on the Human Eye With Fast and Slow Myopia Progression Rate

A study testing Atropine (0.01%) and Artificial tear in people with Myopia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

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

Our project is a 24-month longitudinal randomized controlled trial that aims to investigate the myopia development after topical application of 0.01% atropine in children with either fast or slow myopia progression classified according to their initial electro-retinal responses. Read more about this study

Who is it for?: Ages 7 to 10 yearsHealthy volunteers can take part
Conditions the study is for: Myopia
What is being tested?: Atropine (0.01%) and Artificial tear
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 71 participants
Where: 1 siteHong Kong
Study dates: 1 Feb 2018to 31 Aug 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 7 to 10 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Age between 7 and 10 years
Good general health and no family history of ocular diseases
No current or history of epilepsy or asthma
Myopia : -0.50 to -1.00 D (inclusive, both eyes)
Astigmatism : ≤ 0.50 D
No hyperopia, amblyopia or strabismus
No reported ocular eye diseases or disorders
No drug allergy

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

School of Optometry, Hong Kong Polytechnic University
Hong Kong, 00000

Other trials in Hong Kong

About this study

Official title: Treatment Effect of Topical Application of Low-concentration (0.01%) Atropine on the Human Eye With Fast and Slow Myopia Progression Rate as Classified by Electro-retinal Responses

Conditions: Myopia
Being tested: Atropine (0.01%), Artificial tear
Keywords: Myopia, Myopia control, Atropine, Electroretinogram, Multifocal Electroretinogram
Medical subject headings: Myopia

What participants receive

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

Atropine (0.01%)Drug
tropical application
Artificial tearDrug
tropical application

Study groups in NCT03374306
Study group	Role	What they receive
Atropine 0.01%	Experimental	Group receiving atropine treatment for 18 months Receives: Drug: Atropine (0.01%)
Artifical tear	Placebo comparator	Group receiving placebo for 18 months Receives: Drug: Artificial tear

What is being measured

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

Annualized Changes in Refractive Error (SER)
Annualized changes in refractive error (SER) after receiving the 0.01 atropine or artificial tears up to 18 months
Measured: 18 months

Secondary outcomes (1)

Annualized Change in Axial Length
Annualized change in axial length after receiving the 0.01 atropine or artificial tears up to 18 months
Measured: 18 months

Timeline

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

1 Feb 201831 Aug 2020

First posted15 Dec 2017
Study start1 Feb 2018
Primary completion31 Dec 2019
Study completion31 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for MyopiaStudies of the same condition, open and under way.
More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized clinical trial
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 71 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03374306
Sponsor's protocol ID: HongKongPU_Optometry1
Status last verified: Oct 2024
First submitted: 11 Dec 2017
Last updated: 16 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
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Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment Effect of Topical Application of Low-concentration (0.01%) Atropine on the Human Eye With Fast and Slow Myopia Progression Rate as Classified by Electro-retinal Responses
ClinicalTrials.gov ID: NCT03374306
Acronym / sponsor ID: HongKongPU_Optometry1
Conditions: Myopia
Keywords: Myopia, Myopia control, Atropine, Electroretinogram, Multifocal Electroretinogram
Study type: Interventional
Recruitment status: Completed
Enrolment: 71 participants (actual)
Lead sponsor: The Hong Kong Polytechnic UniversityUniversity, hospital or other
Collaborators: The University of Hong Kong
Study start: 1 Feb 2018 (actual)
Primary completion: 31 Dec 2019 (actual)
Study completion: 31 Aug 2020 (actual)
First posted: 15 Dec 2017 (actual)
Results: Posted 16 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: Randomized clinical trial

Arm	Type	Receives
Atropine 0.01%	Experimental	Drug: Atropine (0.01%)Group receiving atropine treatment for 18 months
Artifical tear	Placebo comparator	Drug: Artificial tearGroup receiving placebo for 18 months

Who may qualify

Ages: 7 to 10 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (8 listed)

Age between 7 and 10 years
Good general health and no family history of ocular diseases
No current or history of epilepsy or asthma
Myopia : -0.50 to -1.00 D (inclusive, both eyes)
Astigmatism : ≤ 0.50 D

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Atropine (0.01%)tropical application	Drug	Atropine 0.01%
Artificial teartropical application	Drug	Artifical tear

Primary outcome

Annualized Changes in Refractive Error (SER)
Time frame: 18 months
Annualized changes in refractive error (SER) after receiving the 0.01 atropine or artificial tears up to 18 months

1 secondary outcome

Annualized Change in Axial Length
Time frame: 18 months

Results and safety

Results posted to the registry on 16 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Atropine 0.01%	36	34
Artifical Tear	35	27

Primary outcome: Annualized Changes in Refractive Error (SER)

Time frame: 18 months. Mean (Standard Deviation). Unit: Dioptre/year

Measure	Atropine 0.01% n = 34	Artifical Tear n = 27
Value	-0.70 (0.39)	-0.66 (0.41)

Population analysed: Annualized changes in refractive error (SER)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 18 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Atropine 0.01%	0 of 34 (0%)	0 of 34 (0%)	0 of 34
Artifical Tear	0 of 27 (0%)	0 of 27 (0%)	0 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Myopia

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Henry HL CHAN, PhD principal investigator

The Hong Kong Polytechnic University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Atropine (0.01%) and Artificial tear in people with Myopia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

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 8 inclusion and 0 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 16 Oct 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 Hong Kong. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Annualized Changes in Refractive Error (SER) (time frame: 18 months). 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 NCT03374306.

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 16 Oct 2024.