drugset / Trial / NCT02594358

Caffeine in Amblyopia Study

NCT02594358

Phase 1/2 Withdrawn Johns Hopkins University
RandomizedSingle-groupSingle-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Caffeine Small molecule 20 mg
Comparator Caffeine Small molecule 40 mg

Indications