Low-Dose Atropine for Treatment of Myopia

Myopia Clinical Trial

— MTS1  

Official title:

Low-Dose Atropine for Treatment of Myopia (Myopia Treatment Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03334253
• Other study ID #: MTS1
• Secondary ID: 2U10EY011751
• Status: Completed
• Phase: Phase 3
• Start date: June 1, 2018
• Est. completion date: September 12, 2022

Study information

• Verified date: August 2023
• Source: Jaeb Center for Health Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 12, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Drug:
• Atropine
Daily 0.01% atropine eyedrops

Other:
• Placebo Eyedrops
Daily placebo eyedrops

Locations

Country	Name	City	State
United States	The Emory Eye Center Dept of Ophthalmology	Atlanta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	St Luke's Hospital	Boise	Idaho
United States	Boston Children's Hospital Waltham	Boston	Massachusetts
United States	Illinois College of Optometry	Chicago	Illinois
United States	Ticho Eye Associates	Chicago Ridge	Illinois
United States	Pediatric Ophthalmology Associates, Inc.	Columbus	Ohio
United States	University of Houston College of Optometry	Houston	Texas
United States	Vanderbilt University Medical Center - Vanderbilt Eye Institute	Nashville	Tennessee
United States	Dean A. McGee Eye Institute, University of Oklahoma	Oklahoma City	Oklahoma
United States	Eye Care Associates, Inc.	Poland	Ohio
United States	Casey Eye Institute	Portland	Oregon
United States	Rocky Mountain Eye Care Associates	Salt Lake City	Utah

Sponsors (3)

Lead Sponsor	Collaborator
Jaeb Center for Health Research	National Eye Institute (NEI), Pediatric Eye Disease Investigator Group

Country where clinical trial is conducted

United States, 

References & Publications (1)

Repka MX, Weise KK, Chandler DL, Wu R, Melia BM, Manny RE, Kehler LAF, Jordan CO, Raghuram A, Summers AI, Lee KA, Petersen DB, Erzurum SA, Pang Y, Lenhart PD, Ticho BH, Beck RW, Kraker RT, Holmes JM, Cotter SA; Pediatric Eye Disease Investigator Group. Lo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Group Comparison of Change in Spherical Equivalent Refractive Error.	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.	At 24 months
Secondary	Treatment Group Comparison of Change From Baseline to 30 Months in Spherical Equivalent	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). Calculated based on the model estimates at 24 months.	At 30 months