Low-Dose Atropine for Treatment of Myopia

NCT03334253 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: MTS12U10EY011751
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 13

Brief Summary

Study Objectives The objectives for this randomized trial are:

1. 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. 2.To determine the efficacy of atropine treatment on myopia progression 6 months following cessation of low-dose atropine treatment (Secondary Outcome Off-Treatment).

Conditions

Myopia

Keywords

Myopia; atropine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Treatment Group Comparison of Change From Baseline to 30 Months in Spherical Equivalent

  At 30 months

Study Arms (2)

Atropine Group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

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

Interventions

Atropine DRUG

Daily 0.01% atropine eyedrops

Also known as: Low-Dose Atropine

Atropine Group

Placebo Eyedrops OTHER

Daily placebo eyedrops

Placebo Group

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jaeb Center for Health Research: lead
• Pediatric Eye Disease Investigator Group: collaborator
• National Eye Institute (NEI): collaborator

Study Sites (13)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

The Emory Eye Center Dept of Ophthalmology

Atlanta, Georgia, 30322, United States

Location

St Luke's Hospital

Boise, Idaho, 83702, United States

Location

Illinois College of Optometry

Chicago, Illinois, 60616, United States

Location

Ticho Eye Associates

Chicago Ridge, Illinois, 60415, United States

Location

Boston Children's Hospital Waltham

Boston, Massachusetts, 02453, United States

Location

Pediatric Ophthalmology Associates, Inc.

Columbus, Ohio, 43205, United States

Location

Eye Care Associates, Inc.

Poland, Ohio, 44514, United States

Location

Dean A. McGee Eye Institute, University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

Casey Eye Institute

Portland, Oregon, 97239, United States

Location

Vanderbilt University Medical Center - Vanderbilt Eye Institute

Nashville, Tennessee, 37232, United States

Location

University of Houston College of Optometry

Houston, Texas, 77204, United States

Location

Rocky Mountain Eye Care Associates

Salt Lake City, Utah, 84107, United States

Location

Related Publications (2)

• 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. Low-Dose 0.01% Atropine Eye Drops vs Placebo for Myopia Control: A Randomized Clinical Trial. JAMA Ophthalmol. 2023 Aug 1;141(8):756-765. doi: 10.1001/jamaophthalmol.2023.2855.

  PMID: 37440213 RESULT

• Weise KK, Repka MX, Zhu Y, Manny RE, Raghuram A, Chandler DL, Summers AI, Lee KA, Kehler LAF, Pang Y, Allen MS, Anderson HA, Erzurum SA, Golden RP, Koutnik CA, Kuo AF, Lenhart PD, Mokka PL, Petersen DB, Ticho BH, Wiecek EK, Yin H, Beaulieu WT, Kraker RT, Holmes JM, Cotter SA; Pediatric Eye Disease Investigator Group. Baseline factors associated with myopia progression and axial elongation over 30 months in children 5 to 12 years of age. Optom Vis Sci. 2024 Oct 1;101(10):619-626. doi: 10.1097/OPX.0000000000002187.

  PMID: 39480129 DERIVED

MeSH Terms

Conditions

Myopia

Interventions

Atropine

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Raymond Kraker, PEDIG Coordinating Center Director
• Organization: Jaeb Center for Health Research

rkraker@jaeb.org

8139758690

Study Officials

• 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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: November 7, 2017
• Study Start: June 1, 2018
• Primary Completion: April 15, 2022
• Study Completion: September 12, 2022
• Last Updated: September 5, 2023
• Results First Posted: May 11, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

US (13)