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Caffeine in Amblyopia Study

NCT02594358 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2017-03-07

No results posted yet for this study

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

Interventions

DRUG

Caffeine

20 MG OR 40 MG ONCE DAILY ALONG WITH PATCHING

Sponsors & Collaborators

Principal Investigators

  • Michael X Repka, MD, MBA · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2017-12-31
Completion
2018-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02594358 on ClinicalTrials.gov