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

NCT02347631 | Completed Results FDA Device

• 1 other identifier: STU112014-068
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Desquamation Rate of Wearing Alcon DAILIES, Then AcuVue TruEye Contact Lenses

  Group 1: Rate of desquamation of corneal epithelial cells (cells/min) will be assessed for participants wearing Alcon DAILIES contacts lenses. 1. Initial 1 mo. washout period (baseline 1). 2. Participant wears the Alcon DAILIES contacts for 2 months after baseline 1. Group 2: Rate of desquamation of corneal epithelial cells (cells/min) will be assessed for participants wearing AcuVue TRUEYE contact lenses. 1. Second 1 mo. washout period (baseline 2). 2. Participant wears the Acuvue TRUEYE contacts for 2 months after baseline 2.

  Baseline + 3 months

• Desquamation Rate of Wearing Acuvue TruEye, Then Alcon DAILIES Contact Lenses

  Group 1: Rate of desquamation of corneal epithelial cells (cells/min) will be assessed for participants wearing Acuvue TRUEYE contacts lenses. 1. Initial 1 mo. washout period (baseline 1). 2. Participant wears the Acuvue TRUEYE contacts for 2 months after baseline 1. Group 2: Rate of desquamation of corneal epithelial cells (cells/min) will be assessed for participants wearing Alcon DAILIES contact lenses. 1. Second 1 mo. washout period (baseline 2). 2. Participant wears the Alcon DAILIES contacts for 2 months after baseline 2.

  Baseline + 3 months

Study Arms (2)

Alcon DAILIES TOTAL1, and ACUVUE TruEye

EXPERIMENTAL

Intervention: Soft Contact Lens - Daily Disposable Name - Alcon Dailies Total 1 Material - Delefilcon A Water Content - 33% Oxygen Permeability - 140 x10-11 (cm2/sec)(mL O2/mL mmHg) Oxygen Transmissibility - 156 x10-9 (cm/sec)(mL O2/mL mmHg) Base Curve - 8.5mm Manner of Wear - Daily Disposables Wearing Time - 2 months

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

ACUVUE TruEye and Alcon Dailies Total 1

ACTIVE COMPARATOR

Intervention: Soft Contact Lens - Daily Disposable Name - Acuvue TruEye Material - Narafilcon A Water Content - 46% Oxygen Permeability - 100 x10-11 (cm2/sec)(mL O2/mL mmHg) Oxygen Transmissibility - 118 x10-9 (cm/sec)(mL O2/mL mmHg) Base Curve - 8.5mm \& 9.0mm Manner of Wear - Daily Disposables Wearing Time - 2 months

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

Interventions

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

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.

Alcon DAILIES TOTAL1, and ACUVUE TruEye

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

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.

ACUVUE TruEye and Alcon Dailies Total 1

Eligibility Criteria

• Age: 21 Years - 38 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Aston Ambulatory Care Center

Dallas, Texas, 75390-8866, United States

Location

Related Publications (1)

• Zhou S, Robertson DM. Wide-Field In Vivo Confocal Microscopy of Meibomian Gland Acini and Rete Ridges in the Eyelid Margin. Invest Ophthalmol Vis Sci. 2018 Aug 1;59(10):4249-4257. doi: 10.1167/iovs.18-24497.

  PMID: 30128496 DERIVED

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Danielle Robertson
• Organization: UT Southwestern Medical Center

danielle.robertson@utsouthwestern.edu

214-648-3416

Study Officials

• Danielle M Robertson, O.D., PhD

  UTSW Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: O.D., Ph.D - Clinician Scientist

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: January 27, 2015
• Study Start: April 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: December 10, 2020
• Results First Posted: December 10, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)