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

Completed · Not applicable

Conditions studied: Soft Contact Lenses, Myopia

In brief

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.

Key facts

Study ID

NCT02347631

Run by

University of Texas Southwestern Medical Center

People needed

118

Starts

2016-04-01

Expected to finish

2018-06-01

Last updated by the study team

2020-12-10

Who can join

Age: 21 and older, up to 38. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Aged 21-38 years
• Any sex, race or national origin accepted as with our past studies. Minority representation will be proactively encouraged
• Sign written informed consent
• A habitual contact lens wearer and only wear lenses for daily wear use (no overnight wear)
• Myopia range: -1.00 to -6.00 with regular astigmatism (≤1 Diopter, both eyes)
• Be willing to wear spectacles for two 1-month washout periods
• Have acceptable fit with test lenses and be willing to wear lenses for the duration of the study.
• Need correction in both eyes and be correctable to within 3 letters (high contrast Snellen VA) of their current contact lens prescription at baseline in each eye with the test lenses.
• No history of allergic eye disease either seasonal or associated with previous contact lens wear.
• A routine screening complete ocular examination (COE) with ocular findings considered to be within normal limits.
• Be willing and able to follow instructions regarding the wear of the daily disposable lenses and attend the scheduled follow-up visits.
• Must be able to arrange weekday appointments between 8:00 (morning) and 12:00 (noon).

You may not qualify if…

• Habitual lens wearers unable to wear lenses for a minimum of 8 hours per day.
• Use of concurrent ocular medication
• Habitual toric or bifocal contact lens wearers
• Any previous history of keratorefractive surgery or recent ocular injuries or ocular surgery within the prior 3 months
• Any preexisting ocular disease
• Monocular contact lens wear
• Any systemic disease or ocular abnormality that may impact optimal contact lens wear
• Use of systemic medications including but not limited to antihistamines, corticosteroids, anticholinergics or immunomodulatory agents
• Pregnancy or lactation
• Concurrent enrollment in another clinical trial

Where it is running

• Aston Ambulatory Care Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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