NCT03408444

Evaluating Soft Contact Lens Prototypes for Myopia Control

• Status: Completed
• Phase: —
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Johnson & Johnson Vision Care, Inc. · Industry
• Sex: All
• Age: 7 Years – 12 Years
• Healthy volunteers: Accepted

Summary

This is a multi-site, prospective, randomized, controlled, double-masked, four-arm-parallel-group, dispensing study. Each subject will be bilaterally fitted with one of four types of test articles and wear contact lenses of the assigned lens type during the entire course of the study. Test articles will be worn a minimum 8 hours per day and 5 days per week (subjects will be encouraged to wear study contact lenses 10 hours or more per day and 7 days per week) in a daily disposable modality for a minimum of 6 months and up to 1 year for a total of 7 scheduled visits.

Conditions

• Visual Acuity

Interventions

Type	Name	Description
DEVICE	EMO-114	Subjects between the ages of 7 and 12 years old will be bilaterally fitted with one of the four types of test articles and wear lenses of the assigned lens type during the entire course of the study.
DEVICE	EMO-116	Subjects between the ages of 7 and 12 years old will be bilaterally fitted with one of the four types of test articles and wear lenses of the assigned lens type during the entire course of the study.
DEVICE	EMO-118	Subjects between the ages of 7 and 12 years old will be bilaterally fitted with one of the four types of test articles and wear lenses of the assigned lens type during the entire course of the study.
DEVICE	EMO-117	Subjects between the ages of 7 and 12 years old will be bilaterally fitted with one of the four types of test articles and wear lenses of the assigned lens type during the entire course of the study.

Timeline

• Start date: 2017-12-27
• Primary completion: 2019-05-25
• Completion: 2019-05-25
• First posted: 2018-01-24
• Last updated: 2022-06-08
• Results posted: 2022-06-08

Locations

1 site across 1 country: China