Evaluating Soft Contact Lens Prototypes for Myopia Control

Johnson & Johnson Vision Care, Inc.1 site in 1 country240 target enrollmentDecember 27, 2017

ConditionsVisual Acuity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.
Enrollment: 240
Locations: 1
Primary Endpoint: Axial Length
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 27, 2017

End Date

May 25, 2019

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Johnson & Johnson Vision Care, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Potential subjects must satisfy all of the following criteria to be enrolled in the study:
•The subject must read (or be read to), understand, and sign the Statement of Information and Assent and receive a fully executed copy of the form.
•The subject's parent(s) or legal guardian(s) must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form.
•Appear able and willing to adhere to the instructions set forth in this clinical protocol.
•Between 7 and 12 years of age (inclusive).
•Have normal eyes (i.e., no ocular medications or infections of any type).
•Distance subjective best-sphere refraction must be between -0.75D and -4.50D (inclusive) in each eye.
•Cylindrical refraction must be 1.00D or less in each eye, by subjective sphero-cylindrical refraction.
•Have sphero-cylindrical best-corrected visual acuity of 20/25 (ie, 0.8 in decimal convention or 0.10 logMAR) or better in each eye.
•Cycloplegic objective sphero-cylindrical refraction (by auto refraction) must be between -0.75D and -4.50D in sphere and is 1.00D or less in cylinder in each eye (based on the average of 5 repeated sphero-cylindrical refraction measures).

Exclusion Criteria

•Potential subjects who meet any of the following criteria will be excluded from participating in the study:
•Currently pregnant or lactating.
•Any systemic allergies, infectious disease (e.g., hepatitis, tuberculosis), autoimmune disease (e.g., rheumatoid arthritis), or other systemic diseases (e.g., diabetes), by the parent or legal guardian's report, which are known to interfere with contact lens wear and/or participation in the study.
•Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear.
•Any current use of ocular topical medication.
•Any previous or planned ocular or intraocular surgery, including refractive surgery.
•Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
•Participation in any prior myopia control clinical study in the test group.
•Current or recent (within 30 days from enrollment) rigid lens wearers.
•History of orthokeratology treatment or use of other ophthalmic devices (e.g., bifocal, multifocal contact or spectacle lenses) or drugs (e.g., atropine or pirenzepine) for the purpose of controlling myopia progression.