Effects of Low Concentration Atropine on Pupillary Size and Accommodative Amplitude

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03699423
• Other study ID #: CS_AS_18_07
• Status: Completed
• Phase: Phase 1
• Start date: March 8, 2018
• Est. completion date: April 30, 2018

Study information

• Verified date: October 2018
• Source: Hai Yen Eye Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Drug:
• 0.01% atropine eye drops
0.01% atropine sulphate
• 0.02% atropine eye drops
0.02% atropine sulphate
• 0.03% atropine eye drops
0.03% atropine sulphate

Locations

Country	Name	City	State
Vietnam	Department of Ophthalmology - An Sinh Hospital	Ho Chi Minh City

Sponsors (2)

Lead Sponsor	Collaborator
Hai Yen Eye Care	Brien Holden Vision

Country where clinical trial is conducted

Vietnam, 

References & Publications (6)

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):391-9. doi: 10.1016/j.ophtha.2015.07.004. Epub 2015 Aug 11. — View 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. — View 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. Review. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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