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OpenTrials
Completed

NCT Number: NCT03699423

Effects of Low Concentration Atropine on Pupillary Size and Accommodative Amplitude

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

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Ophthalmology - An Sinh Hospital

Ho Chi Minh City, 700000, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

0.01% atropine eye drops

Drug

0.01% atropine sulphate

0.02% atropine eye drops

Drug

0.02% atropine sulphate

0.03% atropine eye drops

Drug

0.03% atropine sulphate

Primary outcomes

  1. Change in pupillary diameter

    Time frame: at baseline, at three day and at two week

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

  2. Change in accommodative amplitude

    Time frame: at baseline, at three day and at two week

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

Sponsors and collaborators

Lead sponsor

Hai Yen Eye Care

Industry

Collaborators

  • Brien Holden Vision

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 9, 2018
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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