NCT03699423

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2018

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 8, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

2 months

First QC Date

October 5, 2018

Last Update Submit

October 5, 2018

Conditions

Myopia

Keywords

myopia controllow concentration atropine eye dropsanti-muscarinic receptorspupil sizeaccommodative amplitude

Outcome Measures

Primary Outcomes (2)

  • Change in pupillary diameter

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

    at baseline, at three day and at two week

  • Change in accommodative amplitude

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

    at baseline, at three day and at two week

Study Arms (3)

0.01% atropine eye drops

ACTIVE COMPARATOR

Participants will receive one drop per eye every night for two weeks

Drug: 0.01% atropine eye drops

0.02% atropine eye drops

ACTIVE COMPARATOR

Participants will receive one drop per eye every night for two weeks

Drug: 0.02% atropine eye drops

0.03% atropine eye drops

ACTIVE COMPARATOR

Participants will receive one drop per eye every night for two weeks

Drug: 0.03% atropine eye drops

Interventions

0.01% atropine eye dropsDRUG

0.01% atropine sulphate

0.01% atropine eye drops
0.02% atropine eye dropsDRUG

0.02% atropine sulphate

0.02% atropine eye drops
0.03% atropine eye dropsDRUG

0.03% atropine sulphate

0.03% atropine eye drops

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology - An Sinh Hospital

Ho Chi Minh City, 700000, Vietnam

Location

Related Publications (7)

  • 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.

    PMID: 26875007BACKGROUND

  • 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.

    PMID: 24310242BACKGROUND

  • 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.

    PMID: 26826749BACKGROUND

  • 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.

    PMID: 27101751BACKGROUND

  • 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.

    PMID: 26271839BACKGROUND

  • 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.

    PMID: 24076540BACKGROUND

  • 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.

    PMID: 38621178DERIVED

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The study treatments will be labelled as A, B and C by one of the team member who does not involve in the assessment and follow-up. The masked study products will then be sent to the study coordinator to dispense
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2018

First Posted

October 9, 2018

Study Start

March 8, 2018

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

October 9, 2018

Record last verified: 2018-10

Locations

VN(1)