Back to results

Effects of Low Concentration Atropine on Pupillary Size and Accommodative Amplitude

Primary Purpose

Myopia

Status

Completed

Phase

Phase 1

Locations

Vietnam

Study Type

Interventional

Intervention

0.01% atropine eye drops

0.02% atropine eye drops

0.03% atropine eye drops

About this trial

This is an interventional supportive care trial for Myopia focused on measuring myopia control, low concentration atropine eye drops, anti-muscarinic receptors, pupil size, accommodative amplitude

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Department of Ophthalmology - An Sinh Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

0.01% atropine eye drops

0.02% atropine eye drops

0.03% atropine eye drops

Arm Description

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

Outcomes

Primary Outcome Measures

Change in pupillary diameter

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

Change in accommodative amplitude

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03699423

First Posted

October 5, 2018

Last Updated

October 5, 2018

Sponsor

Hai Yen Eye Care

Collaborators

Brien Holden Vision

1. Study Identification

Unique Protocol Identification Number

NCT03699423

Brief Title

Effects of Low Concentration Atropine on Pupillary Size and Accommodative Amplitude

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

March 8, 2018 (Actual)

Primary Completion Date

April 30, 2018 (Actual)

Study Completion Date

April 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hai Yen Eye Care

Collaborators

Brien Holden Vision

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myopia

Keywords

myopia control, low concentration atropine eye drops, anti-muscarinic receptors, pupil size, accommodative amplitude

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

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

Allocation

Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0.01% atropine eye drops

Arm Type

Active Comparator

Arm Description

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

Arm Title

0.02% atropine eye drops

Arm Type

Active Comparator

Arm Description

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

Arm Title

0.03% atropine eye drops

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

0.01% atropine eye drops

Intervention Description

0.01% atropine sulphate

Intervention Type

Drug

Intervention Name(s)

0.02% atropine eye drops

Intervention Description

0.02% atropine sulphate

Intervention Type

Drug

Intervention Name(s)

0.03% atropine eye drops

Intervention Description

0.03% atropine sulphate

Primary Outcome Measure Information:

Title

Change in pupillary diameter

Description

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

Time Frame

at baseline, at three day and at two week

Title

Change in accommodative amplitude

Description

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

Time Frame

at baseline, at three day and at two week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Facility Information:

Facility Name

Department of Ophthalmology - An Sinh Hospital

City

Ho Chi Minh City

ZIP/Postal Code

700000

Country

Vietnam

12. IPD Sharing Statement

Citations:

PubMed Identifier

26875007

Citation

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.

Results Reference

background

PubMed Identifier

24310242

Citation

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.

Results Reference

background

PubMed Identifier

26826749

Citation

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.

Results Reference

background

PubMed Identifier

27101751

Citation

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.

Results Reference

background

PubMed Identifier

26271839

Citation

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.

Results Reference

background

PubMed Identifier

24076540

Citation

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.

Results Reference

background

Learn more about this trial

Effects of Low Concentration Atropine on Pupillary Size and Accommodative Amplitude

We'll reach out to this number within 24 hrs