Refractive ErrorsBAMNCT03312257
Bifocal & Atropine in Myopia (BAM) Study
A study testing Multifocal D +2.50 add & 0.01% atropine in people with Refractive Errors, run by Jenny Jones.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Refractive Errors
- What is being tested?
- Multifocal D +2.50 add & 0.01% atropine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Myopia Control in Children With Low-dose Atropine and Soft Bifocal Contact Lenses
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.
Read the detailed description
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.
- Conditions
- Refractive Errors
- Being tested
- Multifocal D +2.50 add & 0.01% atropine
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifocal D +2.50 add & 0.01% atropineCombination product
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.
| Study group | Role | What they receive |
|---|---|---|
| Multifocal D +2.50 add & 0.01% atropine | Experimental | 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. Receives: Combination Product: Multifocal D +2.50 add & 0.01% atropine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (1)
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study startJul 2016
- Primary completionJun 2020
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Refractive ErrorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jenny Jones
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jenny Jones, Ohio State University
- Investigators
- Juan Huang, PhD, OD, Principal investigator, The Ohio State Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312257
- Sponsor's protocol ID
- K23EY025273
- Acronym
- BAM
- Status last verified
- Nov 2022
- First submitted
- 12 Oct 2017
- Last updated
- 9 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Jones JH, Mutti DO, Jones-Jordan LA, Walline JJ. Effect of Combining 0.01% Atropine with Soft Multifocal Contact Lenses on Myopia Progression in Children. Optom Vis Sci. 2022 May 1;99(5):434-442. doi: 10.1097/OPX.0000000000001884. Epub 2022 Feb 25.
PubMed 35511120Huang J, Mutti DO, Jones-Jordan LA, Walline JJ. Bifocal & Atropine in Myopia Study: Baseline Data and Methods. Optom Vis Sci. 2019 May;96(5):335-344. doi: 10.1097/OPX.0000000000001378.
PubMed 31046016
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myopia Control in Children With Low-dose Atropine and Soft Bifocal Contact Lenses
- ClinicalTrials.gov ID
- NCT03312257
- Acronym / sponsor ID
- BAM / K23EY025273
- Conditions
- Refractive Errors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Jenny JonesUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 17 Oct 2017 (actual)
- Results
- Posted 9 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multifocal D +2.50 add & 0.01% atropine | Experimental | Combination Product: Multifocal D +2.50 add & 0.01% atropineThe 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. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multifocal D +2.50 add & 0.01% atropineBiofinity 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. | Combination product | Multifocal D +2.50 add & 0.01% atropine |
Primary outcome
Refractive Error Progression
Time frame: 3 years
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.
1 secondary outcome
Axial Length Progression
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35511120Jones JH, Mutti DO, Jones-Jordan LA, Walline JJ. Effect of Combining 0.01% Atropine with Soft Multifocal Contact Lenses on Myopia Progression in Children. Optom Vis Sci. 2022 May 1;99(5):434-442. doi: 10.1097/OPX.0000000000001884. Epub 2022 Feb 25.
- Derived from this study: PubMed 31046016Huang J, Mutti DO, Jones-Jordan LA, Walline JJ. Bifocal & Atropine in Myopia Study: Baseline Data and Methods. Optom Vis Sci. 2019 May;96(5):335-344. doi: 10.1097/OPX.0000000000001378.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Huang, PhD, OD principal investigator
The Ohio State Univeristy
Questions about this trial
What is this clinical trial studying?
A study testing Multifocal D +2.50 add & 0.01% atropine in people with Refractive Errors, run by Jenny Jones.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Refractive Error Progression (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03312257, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2022.