Axial MyopiaPhase 2NCT03552016
Evaluation of Progression of Myopia in Children Treated With Vitamin B2 and Outdoor Sunlight Exposure
A Phase 2 study testing Oral Riboflavin in people with Axial Myopia and Refractive Errors, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
The investigators plan on using riboflavin (a Vitamin that can easily be taken orally each day) and having the children involved in the study play outside (where there is UV light created by the sun) in order to prevent the eye from becoming progressively more near-sighted. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Axial Myopia, Refractive Errors
- What is being tested?
- Oral Riboflavin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2018to 13 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children ages 6-12 years old with myopia more than 0.50 D and astigmatism no more than 1.5 D.
- Caretakers who choose to enroll their child in the study must agree to participate in the study on their own will after knowledge of potential alternatives (spectacle correction, orthokeratology, atropine eye drops, etc.) are explained to the patient's caretaker.
Who cannot join
- Known allergy to riboflavin
- Birth history of premature birth
- Developmental delay or other neurological or mental conditions
- Major systemic health problems
- Significant anisometropia more than 1.5 Diopters
- Any other eye condition which may complicate interpretation of data including: congenital glaucoma, congenital cataract, ectatic corneal condition, amblyopia or strabismus.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
The investigators plan on using riboflavin (a Vitamin that can easily be taken orally each day) and having the children involved in the study play outside (where there is UV light created by the sun) in order to prevent the eye from becoming progressively more near-sighted.
Read the detailed description
Myopia is equivalent to the colloquial term known as near-sightedness. This, in short, means that the image of one's environment is projected in front of the retina (rather than directly on the retina, which is ideal). Of course, glasses can be used to correct the image disparity that is created by being near-sighted (that is why a lot of people need glasses for blurry vision). However, glasses and spectacles and contacts do not correct the underlying problem. Most near-sightedness is due to the eye being "too long" and therefore the image projects in front of the retina. Ideally, if we could prevent the eye from becoming abnormally "long", then we could prevent the progression of near-sightedness. Indeed, a child may only be slightly near-sighted early in life, but as he/she continues to perform activities within an arms length of their environment, they can become progressively near-sighted. Besides spectacle correction, people have tried topical atropine drops (medicated eye drops) and rigid contact lenses (orthokeratology) to attempt to correct near-sightedness. Atropine drops take a lot of cooperation from parent and child. Orthokeratology also requires a lot of cooperation, but also, does not permanently stall myopic progression. The investigators suggest a different means of potentially preventing near-sightedness from getting worse (and thus prevent the eye from getting "too long"). The investigators plan on using riboflavin (a Vitamin that can easily be taken orally each day) and having the children involved in the study play outside (where there is UV light created by the sun) in order to prevent the eye from becoming progressively more near-sighted.
- Conditions
- Axial Myopia, Refractive Errors
- Being tested
- Oral Riboflavin
- Keywords
- Myopia, Axial Myopia, Children, Refractive Error, Riboflavin, Vitamin B2
- Medical subject headings
- Refractive Errors, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral RiboflavinDrug
Also called Vitamin B2
The intervention doses will be 200 mg oral riboflavin and 400 mg oral riboflavin doses; the placebo dose will be 0 mg of oral riboflavin
| Study group | Role | What they receive |
|---|---|---|
| 200 mg Riboflavin (oral) | Experimental | These patients (approximately 1/3rd of all patients enrolled in the study) will be given 200 mg oral riboflavin each day for 6 months and be encouraged to play outside for 30 minutes a day every day. Receives: Drug: Oral Riboflavin |
| 400 mg Riboflavin (oral) | Experimental | These patients (approximately 1/3rd of all patients enrolled in the study) will be given 400 mg oral riboflavin each day for 6 months and be encouraged to play outside for 30 minutes a day every day. Receives: Drug: Oral Riboflavin |
| 0 mg Riboflavin (oral) | Placebo comparator | These patients (approximately 1/3rd of all patients enrolled in the study) will be given 0 mg oral riboflavin (placebo) each day for 6 months and be encouraged to play outside for 30 minutes a day every day. Receives: Drug: Oral Riboflavin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cycloplegic refraction
We will measure the average change in cycloplegic refraction over 3 years in each treatment/study group.
Measured: 3 years
Secondary outcomes (3)
Change in axial length
Change in axial length over 3 years in each treatment/study group.
Measured: 3 years
Change in keratometry values
Change in keratometry values over 3 years in each study group.
Measured: 3 years
Change in uncorrected best visual acuity
Change in uncorrected best visual acuity over 3 years in each study group.
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 posted11 Jun 2018
- Study start10 Oct 2018
- Primary completion13 Dec 2021
- Study completion13 Dec 2021
Why it stopped: Lack of funds and move of all investigators to other institutions.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axial MyopiaStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- This is a 1:1:1 double-blinded randomized study for children ages 6-12 year old with axial myopia who will be treated with one of three different doses of oral riboflavin. Expected number of participants is 100.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohannad Al-Samarraie, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03552016
- Sponsor's protocol ID
- 2011340 HS
- Status last verified
- Aug 2026
- First submitted
- 28 May 2018
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Progression of Myopia in Children Treated With Vitamin B2 and Outdoor Sunlight Exposure
- ClinicalTrials.gov ID
- NCT03552016
- Acronym / sponsor ID
- 2011340 HS
- Conditions
- Axial Myopia, Refractive Errors
- Keywords
- Myopia, Axial Myopia, Children, Refractive Error, Riboflavin, Vitamin B2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funds and move of all investigators to other institutions.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 13 Dec 2021 (actual)
- First posted
- 11 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators plan on using riboflavin (a Vitamin that can easily be taken orally each day) and having the children involved in the study play outside (where there is UV light created by the sun) in order to prevent the eye from becoming progressively more near-sighted.
Detailed description
Myopia is equivalent to the colloquial term known as near-sightedness. This, in short, means that the image of one's environment is projected in front of the retina (rather than directly on the retina, which is ideal). Of course, glasses can be used to correct the image disparity that is created by being near-sighted (that is why a lot of people need glasses for blurry vision). However, glasses and spectacles and contacts do not correct the underlying problem. Most near-sightedness is due to the eye being "too long" and therefore the image projects in front of the retina. Ideally, if we could prevent the eye from becoming abnormally "long", then we could prevent the progression of near-sightedness. Indeed, a child may only be slightly near-sighted early in life, but as he/she continues to perform activities within an arms length of their environment, they can become progressively near-sighted. Besides spectacle correction, people have tried topical atropine drops (medicated eye drops) and rigid contact lenses (orthokeratology) to attempt to correct near-sightedness. Atropine drops take a lot of cooperation from parent and child. Orthokeratology also requires a lot of cooperation, but also, does not permanently stall myopic progression. The investigators suggest a different means of potentially preventing near-sightedness from getting worse (and thus prevent the eye from getting "too long"). The investigators plan on using riboflavin (a Vitamin that can easily be taken orally each day) and having the children involved in the study play outside (where there is UV light created by the sun) in order to prevent the eye from becoming progressively more near-sighted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- This is a 1:1:1 double-blinded randomized study for children ages 6-12 year old with axial myopia who will be treated with one of three different doses of oral riboflavin. Expected number of participants is 100.
| Arm | Type | Receives |
|---|---|---|
| 200 mg Riboflavin (oral) | Experimental | Drug: Oral RiboflavinThese patients (approximately 1/3rd of all patients enrolled in the study) will be given 200 mg oral riboflavin each day for 6 months and be encouraged to play outside for 30 minutes a day every day. |
| 400 mg Riboflavin (oral) | Experimental | Drug: Oral RiboflavinThese patients (approximately 1/3rd of all patients enrolled in the study) will be given 400 mg oral riboflavin each day for 6 months and be encouraged to play outside for 30 minutes a day every day. |
| 0 mg Riboflavin (oral) | Placebo comparator | Drug: Oral RiboflavinThese patients (approximately 1/3rd of all patients enrolled in the study) will be given 0 mg oral riboflavin (placebo) each day for 6 months and be encouraged to play outside for 30 minutes a day every day. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Healthy children ages 6-12 years old with myopia more than 0.50 D and astigmatism no more than 1.5 D.
- Caretakers who choose to enroll their child in the study must agree to participate in the study on their own will after knowledge of potential alternatives (spectacle correction, orthokeratology, atropine eye drops, etc.) are explained to the patient's caretaker.
Key exclusion criteria (6 listed)
- Known allergy to riboflavin
- Birth history of premature birth
- Developmental delay or other neurological or mental conditions
- Major systemic health problems
- Significant anisometropia more than 1.5 Diopters
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 |
|---|---|---|
| Oral RiboflavinAlso: Vitamin B2The intervention doses will be 200 mg oral riboflavin and 400 mg oral riboflavin doses; the placebo dose will be 0 mg of oral riboflavin | Drug | 0 mg Riboflavin (oral), 200 mg Riboflavin (oral), 400 mg Riboflavin (oral) |
Primary outcome
Change in cycloplegic refraction
Time frame: 3 years
We will measure the average change in cycloplegic refraction over 3 years in each treatment/study group.
3 secondary outcomes
Change in axial length
Time frame: 3 years
Change in keratometry values
Time frame: 3 years
Change in uncorrected best visual acuity
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Axial Myopia
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SmoothCore Orthokeratology Plus M.O.V.E. Lenses vs. M.O.V.E. Lenses Alone for Myopia Control in Children With High Myopia
High Myopia
Not yet recruiting
Comparing Myopia Control Spectacle Lenses and Standard Single Vision Spectacle Lenses in Children With Myopia
Myopia, Myopia Progression
Recruiting
Targeted Lens Intervention for Myopic Anisometropia in Children
Anisometropia, Myopia
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Effect of a Myopia Control Lens on the Astigmatism in Children
Astigmatism, Myopia
Active, not recruitingPhase 3
MAD Trial: Myopia Atropine Dose
Progressive Myopia
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.
Mohannad Al-Samarraie, MD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral Riboflavin in people with Axial Myopia and Refractive Errors, run by University of Missouri-Columbia at 1 site in United States.
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 2 inclusion and 6 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: withdrawn, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in cycloplegic refraction (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2026.