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Evaluating Soft Contact Lens Prototypes for Myopia Control

NCT03408444 · Status: COMPLETED · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2022-06-08

Study results available
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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

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.

Sponsors & Collaborators

  • Johnson & Johnson Vision Care, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-27
Primary Completion
2019-05-25
Completion
2019-05-25

Countries

  • China

Study Locations

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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 NCT03408444 on ClinicalTrials.gov