NCT02594358

Caffeine in Amblyopia Study

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 7 Years – 13 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Caffeine	20 MG OR 40 MG ONCE DAILY ALONG WITH PATCHING

Timeline

• Start date: 2014-10-01
• Primary completion: 2017-12-01
• Completion: 2018-12-01
• First posted: 2015-11-03
• Last updated: 2017-03-07

Locations

1 site across 1 country: United States