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Evaluation of Approved and Investigational Contact Lenses

NCT03228212 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2018-12-13

Study results available
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Summary

This study is a randomized, 5-visit, partial subject masked, 2x3 bilateral crossover, dispensing clinical trial. During the study, each test article will be worn in a daily wear modality for at least 6 hours per day and 5 days per week for approximately 2 weeks each. The subject will wear either the Test or Control article twice and the other study article once. The primary objective of this study is to demonstrate that the Test lens works as well, if not better compared to the Control lens with respect to CLUE (Contact Lens User Experience) comfort, Slit Lamp findings, and Distance Monocular logMAR Visual Acuity. This study will also aim to show acceptable lens fit for subjects wearing the Test lens.

Conditions

  • Visual Acuity

Interventions

DEVICE

CONTROL

ACUVUE OASYS

DEVICE

TEST

senofilcon A with new UV blocker

Sponsors & Collaborators

  • Johnson & Johnson Vision Care, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-14
Primary Completion
2017-09-18
Completion
2017-09-18
FDA Device
Yes

Countries

  • United States

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 NCT03228212 on ClinicalTrials.gov