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Low-Dose Atropine for Treatment of Myopia (MTS1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03334253
Recruitment Status : Active, not recruiting
First Posted : November 7, 2017
Last Update Posted : June 9, 2020
Sponsor:
Collaborators:
Pediatric Eye Disease Investigator Group
National Eye Institute (NEI)
Information provided by (Responsible Party):
Jaeb Center for Health Research

Brief Summary:

Study Objectives

The objectives for this randomized trial are:

  1. To determine the efficacy of daily low-dose atropine (0.01%) for slowing myopia progression over a two-year treatment period in children aged 5 to less than 13 years (Primary Outcome On-Treatment).
  2. To determine the efficacy of atropine treatment on myopia progression 6 months following cessation of low-dose atropine treatment (Secondary Outcome Off-Treatment).

Synopsis of Study Design The current study is designed as an efficacy study, making effort to maximize adherence to treatment group assignments. After a run-in phase during which all participants are treated with daily artificial tear eyedrops for 2-4 weeks (and glasses are updated if required) to assess their ability to adhere to daily eye drops, participants are randomly assigned to daily atropine or placebo for 24 months, followed by 6 months off treatment.


Condition or disease Intervention/treatment Phase
Myopia Drug: Atropine Other: Placebo Eyedrops Phase 3

Detailed Description:

Study Objectives

The objectives for this randomized trial are:

  1. To determine the efficacy of daily low-dose atropine (0.01%) for slowing myopia progression over a two-year treatment period in children aged 5 to less than 13 years with myopia -1.00 to -6.00D at the time of enrollment (Primary Outcome On-Treatment).
  2. To determine the efficacy of atropine treatment on myopia progression 6 months following cessation of low-dose atropine treatment (Secondary Outcome Off-Treatment).

Synopsis of Study Design The current study is designed as an efficacy study, making effort to maximize adherence to treatment group assignments. After a run-in phase during which all participants are treated with daily artificial tear eyedrops for 2-4 weeks (and glasses are updated if required) to assess their ability to adhere to daily eye drops, participants are randomly assigned to daily atropine or placebo for 24 months, followed by 6 months off treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 187 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The current study is designed as an efficacy study, making effort to maximize adherence to treatment group assignments. After a run-in phase during which all participants are treated with daily artificial tear eyedrops for 2-4 weeks (and glasses are updated if required) to assess their ability to adhere to daily eye drops, participants are randomly assigned to daily atropine or placebo for 24 months, followed by 6 months off treatment.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Cycloplegic autorefraction, axial length, and additional biometry will be measured by a masked examiner at all follow-up visits using the same instrumentation on the participant throughout the study. Masking will be accomplished by having site personnel administer cyclopentolate to both eyes of each participant and wait 30 minutes before he/she sees the masked examiner. The masked examiner may be a technician or an investigator and must be certified to complete these measurements. Parents, patients, and investigators are also masked to treatment.
Primary Purpose: Treatment
Official Title: Low-Dose Atropine for Treatment of Myopia (Myopia Treatment Study)
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Atropine Group
0.01% atropine eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off atropine eyedrops
Drug: Atropine
Daily 0.01% atropine eyedrops
Other Name: Low-Dose Atropine

Placebo Comparator: Placebo Group
Placebo eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off placebo eyedrops
Other: Placebo Eyedrops
Daily placebo eyedrops




Primary Outcome Measures :
  1. Treatment group comparison of change in spherical equivalent refractive error. [ Time Frame: At 24 months ]

    The primary analysis will be a treatment group comparison of change from baseline to 24-months in spherical equivalent refractive error (SER), as measured by a masked examiner using cycloplegic autorefraction (on-treatment comparison).

    The mean of the three readings from autorefraction in each eye will be calculated and then the mean of both eyes for each participant will be used for the analysis.

    The treatment group difference (atropine - placebo) and a 95% confidence interval will be calculated based on the model estimates at 24 months.



Secondary Outcome Measures :
  1. Treatment group comparison of change from baseline to 30 months in spherical equivalent [ Time Frame: At 30 months ]
    Treatment group comparison of change from baseline to 30 months in spherical equivalent in each eye as measured by a masked examiner using cycloplegic autorefraction (off-treatment comparison).



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 5 years to <13 years at time of enrollment. Children within 4 weeks of their 13th birthday are not eligible.
  • Refractive error meeting the following by cycloplegic autorefraction:

    • Myopia -1.00D to -6.00D spherical equivalent (SE) in both eyes
    • Astigmatism <=1.50D in both eyes
    • Anisometropia <1.00D SE
  • Gestational age ≥ 32 weeks.
  • Birth weight >1500g.
  • Parent understands the protocol and is willing to accept randomization to atropine or placebo.
  • Is willing to participate in a 2 to 4 week run-in phase using daily artificial tear eyedrops.
  • Able to return in 2 to 4 weeks for possible randomization.
  • Parent has a phone (or access to phone) and is willing to be contacted by Investigator's site staff.
  • Relocation outside of the area of an active PEDIG site within next 32 months is not anticipated.

Exclusion Criteria:

  • Current or previous myopia treatment with atropine, pirenzepine or other anti-muscarinic agent.
  • Current or previous use of bifocals, progressive-addition lenses, or multi-focal contact lenses.
  • Current or previous use of orthoK, rigid gas permeable, or other contact lenses being used to reduce myopia progression.
  • Known atropine allergy.
  • Abnormality of the cornea, lens, central retina, iris or ciliary body.
  • Current or prior history of manifest strabismus, amblyopia, or nystagmus.
  • Prior eyelid, strabismus, intraocular, or refractive surgery.
  • Down syndrome or cerebral palsy.
  • Females who are pregnant, lactating, or intending to become pregnant within the next 30 months.

    • A negative urine pregnancy test will be required for all females who have experienced menarche.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03334253


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Georgia
The Emory Eye Center Dept of Ophthalmology
Atlanta, Georgia, United States, 30322
United States, Idaho
St Luke's Hospital
Boise, Idaho, United States, 83702
United States, Illinois
Ticho Eye Associates
Chicago Ridge, Illinois, United States, 60415
Illinois College of Optometry
Chicago, Illinois, United States, 60616
United States, Massachusetts
Boston Children's Hospital Waltham
Boston, Massachusetts, United States, 02453
United States, Ohio
Pediatric Ophthalmology Associates, Inc.
Columbus, Ohio, United States, 43205
Eye Care Associates, Inc.
Poland, Ohio, United States, 44514
United States, Oklahoma
Dean A. McGee Eye Institute, University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Casey Eye Institute
Portland, Oregon, United States, 97239
United States, Tennessee
Vanderbilt University Medical Center - Vanderbilt Eye Institute
Nashville, Tennessee, United States, 37232
United States, Texas
University of Houston College of Optometry
Houston, Texas, United States, 77204
United States, Utah
Rocky Mountain Eye Care Associates
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
Jaeb Center for Health Research
Pediatric Eye Disease Investigator Group
National Eye Institute (NEI)
Investigators
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Study Chair: Michael X Repka, MD, MBA Wilmer Eye Institute
Study Chair: Katherine K Weise, OD, MBA University of Alabama Birmingham Pediatric Eye Care, Birmingham Health Care
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Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT03334253    
Other Study ID Numbers: MTS1
2U10EY011751 ( U.S. NIH Grant/Contract )
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the PEDIG public website after the completion of each protocol and publication of the primary manuscript.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: After completion of the protocol and publication of the primary manuscript, the data will be made available for the duration of the grant and any future grants.
Access Criteria: Users accessing the data must enter an email address.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jaeb Center for Health Research:
Myopia
atropine
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases
Atropine
Ophthalmic Solutions
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmaceutical Solutions