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Clinical Evaluation of Multifocal Toric Contact Lenses

NCT03208088 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2020-09-10

Study results available
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Summary

This is a double-masked, bilateral, randomized, non-dispensing clinical trial. The study lenses will be worn in a bilateral and random fashion using a 5x5 crossover Williams design with 5 lens types and 5 periods. The subjects will wear each pair of lenses for approximately 15 minutes with a 15 minute wash-out between each pair. Two lens types will be fit at the first visit and three lens types will be fit at the second visit. Using a computer-generated randomization scheme, each subject will randomly be assigned to 1 of 10 unique sequences of the 5 lens types. Randomization will be stratified by site.

Conditions

  • Visual Acuity

Interventions

DEVICE

etafilcon A Investigational Toric Multifocal Contact Lens

Test Lens 1

DEVICE

etafilcon A Investigational Toric Multifocal Contact Lens

Test Lens 2

DEVICE

etafilcon A Investigational Toric Multifocal Contact Lens

Tes Lens 3

DEVICE

etafilcon A Investigational Toric Multifocal Contact Lens

Test Lens 4

DEVICE

etafilcon A Investigational Toric Multifocal Contact Lens

Control Lens

Sponsors & Collaborators

  • Johnson & Johnson Vision Care, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-12
Primary Completion
2017-07-21
Completion
2017-07-21
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 NCT03208088 on ClinicalTrials.gov