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New treatment option for Myopia
Official title A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
ClinicalTrials.gov ID: NCT07095894
What this study is testing
What is Atropine?
Atropine is an investigational medicine, given as an once-daily, being studied as a potential treatment for myopia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To date, randomized trials of low-concentration atropine eyedrops and specially designed spectacle lenses to slow the progression of myopia are limited in number and results are inconsistent in non-Asian children. Although results of some recent randomized clinical trials outside the US are promising, additional studies in children are needed to test the safety and efficacy of low-concentration atropine and specially designed spectacle lenses as treatments to slow the progression of myopia during the peak years for eye growth.
- Phase 3: a large, late-stage study
- Time commitment: about 24 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 11
You may be able to join if
- Age 5 years to \<12 years at time of enrollment. Children within 4 weeks of their 12th birthday are not eligible.
- Refractive error meeting the following by cycloplegic autorefraction:
- Myopia of 0.75D to 6.00D SER and at least 0.75D in both principal meridians of each eye
- Astigmatism \<2.50D both eyes
- Anisometropia \<1.50D SER
You likely can't join if
- Current or previous pharmacologic or light therapy used for myopia treatment.
- Current or prior contact lens wear more than 7 days in the past 12 months
- Current or previous use of bifocals, progressive-addition lenses, multi-focal contact lenses, or focus- or contrast-modifying spectacle lenses.
- Current or previous use of orthokeratology, rigid gas permeable, or other contact lenses used to slow myopia progression.
- Current or previous myopia control treatment or other uses of atropine, pirenzepine or other anti-muscarinic agents.
- Known atropine allergy
See the full eligibility criteria
- Age 5 years to \<12 years at time of enrollment. Children within 4 weeks of their 12th birthday are not eligible.
- Refractive error meeting the following by cycloplegic autorefraction:
- Myopia of 0.75D to 6.00D SER and at least 0.75D in both principal meridians of each eye
- Astigmatism \<2.50D both eyes
- Anisometropia \<1.50D SER
- Investigator has confirmed the following regarding best-corrected distance visual acuity (VA) in habitual spectacles or trial frames using the investigator's preferred VA testing method:
- VA is age normal in both eyes1,2
- 5-6 years: approximately 20/32 or better, ≤ 0.24 logMAR, ≥ 73 letters
- 7-12 years: approximately 20/25 or better, ≤ 0.14 logMAR, ≥ 78 letters
- Interocular difference ≤2 logMAR lines (0.2 logMAR) or ≤ 10 letters
- Wearing spectacles by parent report ≥90% of waking hours ≥30 days duration before enrollment. For children who meet all other but whose single-vision spectacles are broken or lost within the last 90 days, enrollment can...
- Gestational age ≥ 32 weeks.
- Birth weight \>1500 g.
- Parent(s) and assenting child understand the study procedures and are willing to accept randomization to atropine 0.05%, HAL lenses, atropine combined with HAL lenses, or placebo (i.e., neither active treatment).
- Parent is willing to participate in a 2- to 4-week run-in phase using nightly artificial tear eyedrops in both eyes.
- Family can return in 2 to 4 weeks for possible randomization.
- Child is willing to refrain from contact lenses for the duration of the study.
- Parent has a phone (or access to a phone) and is willing to be contacted by the clinical site staff.
- Relocation outside of the area of an active PEDIG site within the next 32 months is not anticipated.
- Current or previous pharmacologic or light therapy used for myopia treatment.
- Current or prior contact lens wear more than 7 days in the past 12 months
- Current or previous use of bifocals, progressive-addition lenses, multi-focal contact lenses, or focus- or contrast-modifying spectacle lenses.
- Current or previous use of orthokeratology, rigid gas permeable, or other contact lenses used to slow myopia progression.
- Current or previous myopia control treatment or other uses of atropine, pirenzepine or other anti-muscarinic agents.
- Known atropine allergy
- Known allergy to shellfish
- Abnormality of the cornea, lens, central retina, iris, or ciliary body
- Current constant or intermittent strabismus (phorias are acceptable)
- Verified history of amblyopia or nystagmus.
- Prior strabismus, intraocular, or refractive surgery
- Down syndrome or cerebral palsy
- Diseases known to affect accommodation, vergence, or ocular motility (e.g., multiple sclerosis, Graves' disease, myasthenia gravis, diabetes mellitus)
- Any condition that, in the judgment of the investigator, could influence refractive error development.
- Existing conditions in the opinion of the investigator that may affect the long-term health of the eye or require regular pharmacologic treatment that may adversely interact with study medication (e.g., JIA, glaucoma...
- Inability to comprehend and/or perform any study-related procedures.
- Individuals who are pregnant, lactating, or intending to become pregnant within the next 30 months. a. A negative urine pregnancy test at randomization and the 6-, 12-, 18-, and 24-month follow-up visits will be...
- Immediate family member (spouse, biological or legal guardian, child, sibling, parent) who is investigative site personnel directly affiliated with this study or who is an employee of the Jaeb Center for Health Research.
- Sibling of, or living in the same household as, another child who is concurrently enrolled in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Tucson, Arizona, United States
- Fullerton, California, United States
- Palo Alto, California, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Grand Rapids, Michigan, United States
- Durham, North Carolina, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Norfolk, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 11 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Tucson, Arizona, United States; Fullerton, California, United States; Palo Alto, California, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.