Evaluation of Progression of Myopia in Children Treated With Vitamin B2 and Outdoor Sunlight Exposure

NCT03552016 | Suspended Phase 2 FDA Drug

• 1 other identifier: 2011340 HS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Axial Myopia; Refractive Errors

Keywords

Myopia; Axial Myopia; Children; Refractive Error; Riboflavin; Vitamin B2

Outcome Measures

Primary Outcomes (1)

• Change in cycloplegic refraction

  We will measure the average change in cycloplegic refraction over 3 years in each treatment/study group.

  3 years

Secondary Outcomes (3)

• Change in axial length

  3 years

• Change in keratometry values

  3 years

• Change in uncorrected best visual acuity

  3 years

Study Arms (3)

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.

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.

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.

Drug: Oral Riboflavin

Interventions

Oral Riboflavin DRUG

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

Also known as: Vitamin B2

0 mg Riboflavin (oral); 200 mg Riboflavin (oral); 400 mg Riboflavin (oral)

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Refractive Errors; Myopia

Interventions

Riboflavin

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Flavins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Coenzymes; Enzymes and Coenzymes; Pigments, Biological; Biological Factors

Study Officials

• Mohannad Al-Samarraie, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The researchers involved, the project investigator, and the patients will be blinded from knowing which patient will get which treatment by assigning a number to each patient and having that patient take that number to the pharmacy where they will pick up their riboflavin. The dosage of riboflavin given to the patient will be chosen by the "number" that the patient gives to the pharmacy. There will be no labels revealing the dose of riboflavin that the patient receives. There will be placebo dose which contains a small dose of riboflavin that has been shown to not reach therapeutic levels.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Ophthalmology

Model Details: 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.

Study Record Dates

• First Submitted: May 28, 2018
• First Posted: June 11, 2018
• Study Start: October 10, 2018
• Primary Completion (Estimated): October 10, 2029
• Study Completion (Estimated): October 10, 2030
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)