Bifocal & Atropine in Myopia (BAM) Study

Study Overview
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Brief Summary
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This study will test whether the combined treatment of 0.01% atropine and soft bifocal contact lens wear produces slower myopia progression and axial elongation compared to soft bifocal contact lenses alone in children ages 7 to 11 years old.

Detailed Description
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Both atropine and soft bifocal contact lenses have been shown to slow myopia progression, and both can cause changes in choroidal thickness. But the relationship between these mechanisms is unclear. The central hypothesis to be tested in the BAM Study is that atropine and soft bifocal contact lenses each exert their anti-progression actions through a common pathway that involves the choroid. If this is correct, then adding atropine treatment to soft bifocal contact lens wear will lead to a more effective slowing of myopia progression than prescribing soft bifocal contact lenses alone due to the additive effects in the common pathway. The BAM Study is an ancillary study of an NIH sponsored multi-center, randomized clinical trial, the Bifocal Lenses In Nearsighted Kids (BLINK) Study (NIH: U10EY023208; NCT: NCT02255474). The BLINK Study compares myopia progression between subjects who wear single vision contact lenses and those wearing soft bifocal contact lenses. The BAM Study enrolls an additional 49 subjects that are age-matched with the participants who are wearing +2.50D add soft bifocal contact lenses in the BLINK Study. The subjects in the BAM Study wear +2.50D add soft bifocal contact lenses in combination with daily administration of one drop of 0.01% atropine in each eye for three years. The rates of myopia progression and axial elongation will be compared to the rates in participants who are receiving treatment with +2.50D add soft bifocal contact lenses alone in the BLINK Study. Two specific aims will be addressed: Aim 1: To test whether the combined treatment of 0.01% atropine and soft bifocal contact lens wear produces slower myopia progression and axial elongation compared to soft bifocal contact lenses alone over 3 years. Aim 2: To test whether early changes in choroidal thickness can be used as predictors of long-term myopia progression / axial elongation. The results of this study will have significant implications for future studies to develop and test new therapeutic regimes that optimize the effect of myopia control through combined pharmacological and optical interventions. The outcomes will also aid in understanding the potential role of short-term changes of choroidal thickness in long- term regulation of myopia progression and ocular growth.

Official Title
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Myopia Control in Children With Low-dose Atropine and Soft Bifocal Contact Lenses

Conditions
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Refractive Errors

Intervention / Treatment
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* Combination Product: Multifocal D +2.50 add & 0.01% atropine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 7 to 11 years, inclusive, at baseline examination -0.75 to -5.00 D, inclusive, spherical component, cycloplegic autorefraction ≤1.00 DC, cycloplegic autorefraction ≤ 2.00 D difference between the sphere components of the two eyes (anisometropia), cycloplegic autorefraction 0.1 logMAR or better best-corrected visual acuity in each eye 0.1 logMAR or better visual acuity OU distance and near with a +2.50 D add contact lens +2.50 D add lens provides adequate fit with respect to movement and centration Finish at least 71% of 0.01% atropine during the run-in period Exclusion Criteria: Eye disease or binocular vision problems (e.g., strabismus, amblyopia, oculomotor nerve palsies, corneal disease, etc.) Previous intraocular or corneal surgery Systemic disease that may affect vision, vision development, or contact lens wear (eg, diabetes, Down syndrome, etc.) Previous gas permeable, soft bifocal, or orthokeratology contact lens wear or bifocal/PAL spectacle wear (longer than 1 month of wear) Previous or current participation in myopia control studies Chronic use of medications that may affect immunity, such as oral or ophthalmic corticosteroids for ocular or systemic diseases Issues that may interfere with the ability to participate over the next 3 years

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multifocal D +2.50 add & 0.01% atropine<br>The Biofinity Multifocal D with a +2.50 add is a soft bifocal contact lens that has a strong reading power; the 0.01% atropine is a low-dose atropine. | Combination Product: Multifocal D +2.50 add & 0.01% atropine<br>* Biofinity Multifocal D +2.50 add is a monthly disposable contact lens commercially available from CooperVision; 0.01% atropine is low-dose atropine compounded by local pharmacy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Refractive Error Progression | Refractive error, as measured by cycloplegic autorefraction in both eyes, will be measured yearly to assess the difference in progression between the combination treatment (+2.50 D add soft bifocal lens and 0.01% atropine) group and the historical control group (+2.50 D add soft bifocal lens only) in the BLINK Study. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial Length Progression | Axial length progression, as measured by Lenstar in both eyes, will be measured yearly to assess the difference in progression between the combination treatment (+2.50 D add soft bifocal lens and 0.01% atropine) group and the historical control group (+2.50 D add soft bifocal lens only) in the BLINK Study. | 3 years |