DAILIES TOTAL1 Versus ACUVUE TruEye - Effects on the Biology of the Ocular Surface and Lid Margin

Summary

This is a prospective, single center, randomized, bilateral crossover, dispensing clinical trial to evaluate the effects of the water gradient lens, DAILIES TOTAL1, on the biology of corneal epithelium over two months of daily wear compared to wear of a control high oxygen permeable silicone hydrogel daily disposable contact lens, the ACUVUE TruEye; and to correlate these changes with alterations in the lid wiper, tear film and cellular changes at the limbus. The total proposed duration of this study is 12 months to ensure enrollment of up to 94 established contact lens wearers, with anticipated completion of 84. Data will be collected at baseline and following 2 months of daily wear for each lens type. Based upon data from the investigators previous contact lens clinical trials, a 1 month washout period is required prior to initiating lens wear and also between lens wear periods for the two types of lenses in order to eliminate any potential residual solution or lens effects on the corneal epithelium and restore homeostasis. The study is scheduled to commence upon Institutional Review Board approval.

Conditions

• Soft Contact Lenses
• Myopia

Interventions

DEVICE

Soft Contact Lens - Daily Disposable Alcon Dailies Total 1 and ACUVUE TruEye

Soft contact lens - Daily wear disposable lens to correct myopia in subjects who are nearsighted. Comparison of Alcon Dailies Total 1 versus Acuvue TruEye when worn as daily disposables over a two month period. This is a cross-over study where both brands of lenses will be worn by each participant over the course of the trial. Participants will be randomized for the order in which the two brands of lenses will be worn. There is a washout period of one month in between each 2 month contact lens wearing period. In this experimental arm, Alcon Dailies Total 1 lenses will be worn first.

DEVICE

Soft Contact Lens - Acuvue TruEye and Alcon DAILIES TOTAL 1.

Soft contact lens - Daily wear disposable lens to correct myopia in subjects who are nearsighted. Comparison of Alcon Dailies Total 1 versus Acuvue TruEye when worn as daily disposables over a two month period. This is a cross-over study where both brands of lenses will be worn by each participant over the course of the study. Participants will be randomized for the order in which the two brands of lenses will be worn. There is a washout period of one month in between each 2 month contact lens wearing period. In this active comparator arm, Acuvue TruEye lenses will be worn first.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center

  lead OTHER

Principal Investigators

• Danielle M Robertson, O.D., PhD · UTSW Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

21 Years

Max Age

38 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-04-30

Primary Completion

2018-06-30

Completion

2018-06-30

FDA Device

Yes

Countries

• United States

Study Locations