NCT06029530

Delaying the Onset of Nearsightedness Until Treatment Study

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 6 Years – 11 Years
• Healthy volunteers: Accepted

Summary

Participants eligible for the study will be randomized to one of three concentrations of atropine and followed for a month.

Detailed description

Participants will be identified through screening that fit the criteria of a pre-myopic child, which will depend on age and the amount of refractive error at that time. These children will be randomized for a pilot study measuring compliance in nightly eye drop administration. The outcome will be thirty days after randomization, and will assess whether or not there is a difference in compliance between one of three dosages of atropine (0.01%, 0.03%, and 0.05%).

Conditions

• Myopia

Interventions

Type	Name	Description
DRUG	Atropine Ophthalmic	eye drops to be administered once daily

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2023-09-08
• Last updated: 2024-04-16

Regulatory

• FDA-regulated drug study