Effectiveness of 0.01% Atropine Sulfate Solution in Controlling of Myopia Progression in Children

Open Prospective With Historical Control Clinical Study of 0.01 % Atropine Sulfate Effectiveness in Controlling of Myopia Progression in Children

Increasing number of myopic children and significant complications of high myopia enhance the necessity of effective control strategy. Instillations of low-dose atropine have been shown to reduce myopia progression in Asian populations but its effect in non-Asian populations is still unclear. This open prospective study with historical control is designed to investigate if 0.01% atropine can reduce myopia progression in Russian children, taking into account a change of difference between manifest and cycloplegic refraction, as well as, myopia progression rate at the time of recruitment.

Study Overview

• Status: Unknown
• Conditions: Myopia
• Intervention / Treatment: Combination product: 0.01% Atropine sulfate solution in "Comfort Drops" ("AVIZOR S.A.", Spain)

Detailed Description

The study is designed to test the following hypotheses:

• 0.01% atropine one drop nightly is safe and with no significant side effects.
• nightly instillations of 0.01% atropine does not influence tear production.
• 0.01% atropine one drop nightly reduces the progression of childhood myopia in Russian children.
• nightly instillations of 0.01% atropine decreases the manifest refraction and, consequently, difference between manifest and cycloplegic refractions.
• effectiveness of 0.01% atropine depends on the age and myopia progression rate at the time the therapy was started.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Omsk, Russian Federation, 644024
    • Recruiting
    • The V.P. Vyhodcev Eye Hospital
    • Contact: Daria S Afanasyeva, MD, PhD; Phone Number: +79852731785 +79835279729; Email: ada-tomsk@yandex.ru
    • Contact: Konstantin S Shchukin, MD; Phone Number: Afanasyeva +79236789231; Email: lek.okob@inbox.ru
    • Principal Investigator: Daria S Afanasyeva, MD, PhD
    • Sub-Investigator: Anara H Abdrahmanova, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• myopia progression rate of 0.5D or more per year;
• myopia with astigmatism of 1.0D or less;
• axial length and cycloplegic refraction data obtained 6 months before recruiting or earlier
• signed informed consent.

Exclusion Criteria:

• congenital myopia;
• onset of myopia at 6 years old or earlier;
• allergic reactions to any eye drops in anamnesis;
• concomitant eye disorders, including strabismus.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental; 0.01% Atropine Sulfate solution in "Comfort Drops", nightly instillations to both eyes	Combination product: 0.01% Atropine sulfate solution in "Comfort Drops" ("AVIZOR S.A.", Spain); nightly instillations of 0.01% Atropine sulfate solution in "Comfort Drops" ("AVIZOR S.A.", Spain) in both eyes for 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in axial length	Change in axial length elongation from baseline to 12 months, as measured using IOLMaster, compared with historical data	baseline - 12 months
change in myopic progression rate	Change in myopic progression rate measured as the difference between cycloplegic refraction from baseline to 12 months, compared with historical data.	baseline - 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in difference between manifest and cycloplegic refractions	change in difference between manifest and cycloplegic (tropicamide 0.5%) refractions, measured with autorefractometer, compared with historical data	baseline - 12 months
change in positive relative accommodation	change in positive relative accommodation, measured in maximal spectacles correction by using concave lenses until the image blurs	baseline - 12 months
tear production	result of Schirmer I test	baseline - 12 months

Collaborators and Investigators

• Sponsor: The V.P. Vyhodcev Eye Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2020
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: April 4, 2020
• First Submitted That Met QC Criteria: April 4, 2020
• First Posted (Actual): April 8, 2020

Study Record Updates

• Last Update Posted (Actual): April 9, 2020
• Last Update Submitted That Met QC Criteria: April 8, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: myopia; low dose atropine; progressive myopia; atropine in non-asian population
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Adjuvants, Anesthesia; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Mydriatics; Atropine
• Other Study ID Numbers: 2020-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No