Caffeine in Amblyopia Study

NCT02594358 | Withdrawn Phase 1

• 1 other identifier: NA_00066787
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective data on the visual acuity response in children treated by patching concurrently treated with caffeine and estimate the magnitude of effect that might be seen in a randomized trial (if no improvement in acuity is seen, this would be sufficient evidence to decide not to conduct a randomized, double blind trial). Collect prospective data on the tolerability of caffeine in two dosages as an adjuvant treatment for amblyopia and provide limited data on its safety. Evaluate the potential for a dietary intervention to enhance the acceptance and tolerability of patching on the child and family. Demonstrate recruitment potential of subjects to participate in a dietary intervention study.

Conditions

Amblyopia

Keywords

Caffeine

Outcome Measures

Primary Outcomes (1)

• Visual acuity

  Quantitative improvement in high resolution visual acuity measured at 3 meters

  12 weeks

Secondary Outcomes (1)

• Questionnaire

  12 weeks

Study Arms (2)

Caffeine 20 mg

ACTIVE COMPARATOR

Patching plus once daily caffeine for 12 weeks

Drug: Caffeine

Caffeine 40 mg

ACTIVE COMPARATOR

Patching plus once daily caffeine for 12 weeks

Drug: Caffeine

Interventions

Caffeine DRUG

20 MG OR 40 MG ONCE DAILY ALONG WITH PATCHING

Caffeine 20 mg; Caffeine 40 mg

Eligibility Criteria

• Age: 7 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Amblyopia from strabismus and amblyopia

You may not qualify if:

• Known intolerance to caffeine
• Diagnosis and/or treatment of attention deficit/hyperactivity disorder
• Presence of an ocular cause for reduced visual acuity
• Myopia with a special equivalent -6.00 diopters
• Current vision therapy or orthoptics - any type
• Ocular cause for reduced visual acuity
• Prior intraocular or refractive surgery
• History of narrow-angle glaucoma
• Strabismus surgery planned within 16 weeks
• Nystagmus per se does not exclude the subject if the above visual acuity criteria are met
• Known skin reactions to patch or bandage adhesives
• Known allergy or intolerance to food dyes
• Current treatment with topical atropine eyedrops
• Menarche, pregnancy or lactation
• Use of any of the following medications which may affect caffeine metabolism: nafcillin, verapamil, fluvoxamine, ciprofloxacin and other fluoroquinolones, modafinil, nafcillin, and omeprazole

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Amblyopia

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Michael X Repka, MD, MBA

  Johns Hopkins University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Ophthalmology

Study Record Dates

• First Submitted: October 30, 2015
• First Posted: November 3, 2015
• Study Start: October 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: March 7, 2017

Record last verified: 2017-03

Locations

US (1)