Clinical Evaluation of 3 Contact Lens Materials With 3 Solution Types

Summary

This is a multi-site, randomized, double-masked, contralateral, 2 treatment x 2 period crossover, dispensing, five-visit study to gain clinical insights of the study lenses and solutions.

Conditions

• Visual Acuity, Slit Lamp Biomicroscopy (Corneal Staining Assessment)

Interventions

DEVICE

Opti-Free : RevitaLens / Clear Care : RevitaLens

Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.

DEVICE

Opti-Free : RevitaLens / RevitaLens : Clear Care

Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.

DEVICE

Clear Care : RevitaLens/ Opti-Free : RevitaLens

Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.

DEVICE

Clear Care : RevitaLens / RevitaLens : Opti-Free

Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.

DEVICE

RevitaLens : Clear Care/ Opti-Free : RevitaLens

Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.

DEVICE

RevitaLens : Clear Care / RevitaLens : Opti-Free

Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.

DEVICE

RevitaLens : Opti-Free / Clear Care : RevitaLens

Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.

DEVICE

RevitaLens : Opit-Free / RevitaLens : Clear Care

Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

69 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-02-07

Primary Completion

2018-06-19

Completion

2018-06-19

FDA Device

Yes

Countries

• United States

Study Locations