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

Recruiting at 1 trial location

Overseen By Ryan N Mercer, MD

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Missouri-Columbia

Disqualifiers: Allergy to riboflavin, Premature birth, Developmental delay, Major systemic health problems, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to prevent children from becoming more near-sighted by giving them a vitamin and encouraging outdoor play in sunlight. The combination of the vitamin and UV light may help stop the eye from growing too long, which causes near-sightedness.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is riboflavin safe for human use?

Riboflavin (Vitamin B2) is generally considered safe for human use, as studies have shown it can be used in treatments like corneal collagen crosslinking without damaging cells. However, riboflavin deficiency can lead to health issues, so maintaining adequate levels is important. ^{1 2 3 4 5}

How does the drug Riboflavin differ from other treatments for this condition?

Riboflavin (Vitamin B2) is unique because it can be used in combination with ultraviolet-A (UVA) light for collagen cross-linking, which helps strengthen the cornea in conditions like infectious keratitis. This method is different from standard treatments as it involves a photoactivated process that enhances the structural integrity of the cornea. ^{3 5 6 7 8}

Research Team

Mohannad Al-Samarraie, MD

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

Inclusion Criteria

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.

Children between the ages of 6 and 12 who have nearsightedness (need glasses to see far away) greater than 0.50 D and astigmatism (blurred vision due to an irregularly shaped cornea) no more than 1.5 D.

Exclusion Criteria

Significant anisometropia more than 1.5 Diopters

Birth history of premature birth

You are allergic to riboflavin.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 400 mg, 200 mg, or 0 mg (placebo) of oral riboflavin daily and are encouraged to play outside for 30 minutes each day for 6 months

6 months

Follow-up

Participants are monitored for changes in cycloplegic refraction, axial length, uncorrected best visual acuity, and keratometry values

3 years

Treatment Details

Interventions

• Riboflavin

Participant Groups

Group I: 400 mg Riboflavin (oral) Experimental Treatment 1 Intervention

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.

Group II: 200 mg Riboflavin (oral) Experimental Treatment 1 Intervention

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.

Group III: 0 mg Riboflavin (oral) Placebo Group 1 Intervention

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.

Riboflavin is already approved in United States, European Union for the following indications:

Approved in United States as Riboflavin ophthalmic solution for:

• Progressive keratoconus
• Corneal ectasia following refractive surgery

Approved in European Union as Riboflavin ophthalmic solution for:

• Progressive keratoconus
• Corneal ectasia following refractive surgery

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

Findings from Research

A study involving 100 eyes from 61 patients with progressive keratoconus found that both 0.1% riboflavin solutions used in corneal collagen crosslinking (CXL) were equally safe and effective, with no significant differences in visual and corneal measurements after 12 months.

No serious complications occurred in either group during or after the procedure, indicating that both riboflavin solutions can be safely used for treating keratoconus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective, Comparative, Clinical Study to Evaluate the Safety and Efficacy of Two Different 0.1% Riboflavin Solutions Used in Collagen Crosslinking Treatment for Patients with Keratoconus. Brar, S., Ganesh, S., Reddy, SS., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Novel Riboflavin Formulation for Corneal Delivery Without Damaging Epithelial Cells. [2023]

2. New Zealand pubmed.ncbi.nlm.nih.gov

A Prospective, Comparative, Clinical Study to Evaluate the Safety and Efficacy of Two Different 0.1% Riboflavin Solutions Used in Collagen Crosslinking Treatment for Patients with Keratoconus. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Riboflavin transport mediated by riboflavin transporters (RFVTs/SLC52A) at the rat outer blood-retinal barrier. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Riboflavin deficiency leads to irreversible cellular changes in the RPE and disrupts retinal function through alterations in cellular metabolic homeostasis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Analysis of Riboflavin Compounds in the Rabbit Cornea In Vivo. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Corneal distribution of riboflavin prior to collagen cross-linking. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Can Riboflavin Penetrate Stroma Without Disrupting Integrity of Corneal Epithelium in Rabbits? Iontophoresis and Ultraperformance Liquid Chromatography With Electrospray Ionization Tandem Mass Spectrometry. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Photoactivated riboflavin treatment of infectious keratitis using collagen cross-linking technology. [2022]