AzTrials
AzTrials

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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

Search all trials

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

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

Other trials in United States

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.

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 groups in NCT03552016
Study groupRoleWhat they receive
200 mg Riboflavin (oral)ExperimentalThese 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)ExperimentalThese 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 comparatorThese 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.

  1. 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)
  1. Change in axial length

    Change in axial length over 3 years in each treatment/study group.

    Measured: 3 years

  2. Change in keratometry values

    Change in keratometry values over 3 years in each study group.

    Measured: 3 years

  3. 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.

  1. First posted11 Jun 2018
  2. Study start10 Oct 2018
  3. Primary completion13 Dec 2021
  4. Study completion13 Dec 2021

Why it stopped: Lack of funds and move of all investigators to other institutions.

Resources

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)
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

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in