A comparison of the effects of Alcon DAILIES TOTAL1 and a control high oxygen permeable silicone hydrogel daily disposable contact lens, the ACUVUE TruEye, on the biology of the ocular surface and lid margin

Study ID
STU 112014-068

Cancer Related
No

Healthy Volunteers
Yes

Study Sites

  • UT Southwestern Ambulatory Services

Contact
Manali Shah
214/645-2015
Manali.Shah@UTSouthwestern.edu

Principal Investigator
Danielle Robertson, O.D., Ph.D.

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 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 125 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 our previous contact lens clinical trials, a 1 month washout period is required prior to initiating lens wear to eliminate any potential residual solution or lens effects on the corneal epithelium and restore homeostasis.

Participant Eligibility


* Aged 18-38 years

* Any sex, race or national origin accepted as with our past studies.

* Sign written informed consent

* A habitual contact lens wearer and only wear lenses for daily wear use (no overnight wear) or non contact lens wearers wanting to try contact lenses

* Myopia range: -1.00 to -6.00 with regular astigmatism (<=1.00D, 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 AM and 12:00 PM.