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Safety and Efficacy Study of 0.5%, 0.1% & 0.01% Atropine Treatment to Both Eyes In Treatment of Myopia In Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Singapore National Eye Centre.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Singapore National Eye Centre
ClinicalTrials.gov Identifier:
NCT00371124
First received: August 30, 2006
Last updated: August 30, 2010
Last verified: May 2010
  Purpose

The purpose of this study is to find an optimal dose of atropine for preventing the rapid progression of myopia in children by comparing the efficacy, safety and functional impact of binocular treatment with 0.5%, 0.1% and 0.01% atropine and to develop a treatment regimen for the routine management of childhood myopia.


Condition Intervention Phase
Myopia
Drug: Atropine Eye drops
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomised, Double-Masked Study to Compare The Safety and Efficacy of Bilateral 0.5%, 0.1% & 0.01% Atropine Treatment In Controlling Progression of Myopia In Children

Resource links provided by NLM:


Further study details as provided by Singapore National Eye Centre:

Primary Outcome Measures:
  • Spherical equivalent refraction determined by cycloplegic autorefraction

Secondary Outcome Measures:
  • Axial length determined by non-contact partial coherence interferometry
  • Ocular symptoms
  • Induced cycloplegia assessed by near acuity and amplitude of accommodation tests
  • Pupil reactivity and diameter assessment
  • Ocular surface and anterior segment changes assessed by slit-lamp and intraocular pressure assessed by non-contact tonometry
  • Posterior segment changes assessed by fundus photography and ophthalmoscopy
  • Retinal function assessed by distance acuity test and electroretinography

Estimated Enrollment: 400
Study Start Date: March 2006
Detailed Description:

A Randomised, Double-Masked Study to Compare The Safety and Efficacy of Bilateral 0.5%, 0.1% & 0.01% Atropine Treatment In Controlling Progression of Myopia In Children

Study Duration and Visit Schedule Total of 5 years with 15 scheduled visits.

  1. Phase I: 2 years with 8 scheduled visits
  2. Phase II: 3 years with 7 scheduled visits

STUDY DESIGN This study consists of 2 phases, each with a different design. Phase I is a double-masked single-centre clinical trial wherein 400 children aged 6-12 years, with myopia of -2.00 D or worse in each eye, and from whom assent and parental/guardian consent have been obtained, will be randomised to receive 0.5% atropine, 0.1% atropine or 0.01% atropine once nightly in both eyes. Participants will be assigned to treatment in the ratio of 2:2:1, respectively. Each child will receive treatment for a period of 2 years during which they will be reviewed every 4 months.

Phase II is an open-label study wherein all children will continue to be followed-up regularly for changes in their refractive error after stopping atropine treatment. Those children who demonstrate myopia progression of -0.5 D or more, at least on one eye after a minimum of 8 months washout period will restart atropine treatment in both eyes. The appropriate dose will be determined by analysis of the data from Phase I of the study. Treatment will be for a further 2 years and all children, including those not receiving treatment, will be reviewed every 6 months.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written Informed Consent from parent and assent from child has been obtained
  2. Children aged 6 to 12 years
  3. Refractive error of spherical equivalent -2.00 D or worse in each eye as measured by cycloplegic autorefraction
  4. Active myopia progression of at least spherical equivalent -0.50 D over the last 12 months as determined or suggested by refractive records or change in lens power
  5. Astigmatism of less than or equal to -1.50 D as measured by cycloplegic or non-cycloplegic autorefraction
  6. Distance vision correctable to logMAR 0.2 or better in both eyes
  7. A difference between non-cycloplegic subjective spherical refraction and cycloplegic subjective spherical refraction of not greater than -1.00 D
  8. Normal intraocular pressure of not greater than 21 mmHg
  9. Normal ocular health other than myopia
  10. In good general health with no history of cardiac or significant respiratory diseases
  11. No asthma-requiring medications in the past one year
  12. No allergy to atropine, cyclopentolate, proparacaine and benzalkonium chloride
  13. Willing and able to comply with scheduled visits and other study procedures

Exclusion Criteria:

  1. Ocular or systemic diseases which may affect vision or refractive error
  2. Any ocular condition wherein topical atropine is contraindicated
  3. Defective binocular function or stereopsis
  4. Amblyopia or manifest strabismus including intermittent tropia
  5. Previous or current use of atropine or pirenzepine
  6. Any other conditions precluding adherence to the protocol including unwillingness to refrain from contact lens wear for the duration of the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00371124

Locations
Singapore
Singapore Eye Research Institute
Singapore, Singapore
Sponsors and Collaborators
Singapore National Eye Centre
Investigators
Principal Investigator: Donald Tan, FRCS SNEC, SERI
Principal Investigator: Wei Han Chua, FRCS SNEC, SERI
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00371124     History of Changes
Other Study ID Numbers: R359/17/2004
Study First Received: August 30, 2006
Last Updated: August 30, 2010
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by Singapore National Eye Centre:
Myopia treatment
Atropine

Additional relevant MeSH terms:
Myopia
Eye Diseases
Refractive Errors
Atropine
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Mydriatics
Neurotransmitter Agents
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014