Pre-Lens Tear Film Performance of Silicone Hydrogel Daily Disposable Contact Lenses

Study Overview
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Brief Summary
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The purpose of this study was to compare the pre-lens tear film stability of DAILIES TOTAL1® silicone hydrogel daily disposable contact lenses with that of two other silicone hydrogel daily disposable contact lenses.

Official Title
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Randomized Cross-Over Evaluation of Silicone Hydrogel Daily Disposable Soft Contact Lenses

Conditions
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Myopia

Intervention / Treatment
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* Device: Delefilcon A contact lens
* Device: Narafilcon A contact lens
* Device: Filcon II 3 contact lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be of legal age of consent and sign written Informed Consent document, or if under legal age, have written consent of parent or guardian to participate. Require vision correction in both eyes. Wear either daily disposable contact lenses or weekly/monthly replacement contact lenses in powers between -0.50 and -10.00 diopters, cylinder ≤0.75 diopter, no ADD correction. Wear habitual contact lenses an average of 12-14 hours per day, at least 5 days per week. Willing and able to wear study contact lenses 16 hours per day. Able to achieve visual acuity of at least 6/7.5 in each eye with study lenses. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Currently wearing DAILIES TOTAL1®, 1-DAY ACUVUE® TRUEYE™, or Clariti™ 1day contact lenses. Require monovision correction. Any systemic or ocular disease or disorder (refractive disorder allowed and dry eye permitted), complicating factors, or structural abnormality that would negatively affect the conduct or outcome of the study. Ocular surgery/trauma within the last 6 months. Topical or systemic antibiotic use within 7 days of enrollment. Topical ocular or systemic corticosteroid use within 14 days of enrollment. Pregnant and nursing women. Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment. Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dailies Total 1<br>Delefilcon A, followed by narafilcon A and filcon II 3 in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner. | Device: Delefilcon A contact lens<br>* Silicone hydrogel contact lens for single use, daily disposable wear.<br>* Other names: DAILIES® TOTAL1™;Device: Narafilcon A contact lens<br>* Silicone hydrogel contact lens for single use, daily disposable wear.<br>* Other names: 1-DAY ACUVUE® TRUEYE™;Device: Filcon II 3 contact lens<br>* Silicone hydrogel contact lens for single use, daily disposable wear<br>* Other names: Clariti™ 1-day;|
| Active Comparator: TruEye<br>Narafilcon A, followed by delefilcon A and filcon II 3 in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner. | Device: Delefilcon A contact lens<br>* Silicone hydrogel contact lens for single use, daily disposable wear.<br>* Other names: DAILIES® TOTAL1™;Device: Narafilcon A contact lens<br>* Silicone hydrogel contact lens for single use, daily disposable wear.<br>* Other names: 1-DAY ACUVUE® TRUEYE™;Device: Filcon II 3 contact lens<br>* Silicone hydrogel contact lens for single use, daily disposable wear<br>* Other names: Clariti™ 1-day;|
| Active Comparator: Clariti<br>Filcon II 3, followed by narafilcon A and delefilcon A in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner. | Device: Delefilcon A contact lens<br>* Silicone hydrogel contact lens for single use, daily disposable wear.<br>* Other names: DAILIES® TOTAL1™;Device: Narafilcon A contact lens<br>* Silicone hydrogel contact lens for single use, daily disposable wear.<br>* Other names: 1-DAY ACUVUE® TRUEYE™;Device: Filcon II 3 contact lens<br>* Silicone hydrogel contact lens for single use, daily disposable wear<br>* Other names: Clariti™ 1-day;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-Lens Non-Invasive Tear Break-Up Time (PL-NITBUT) | The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the corneal surface using a CA-1000 topographer, and the tear film reflection was observed on a 30-inch flat panel monitor. PL-NITBUT was recorded at the first sign of image distortion. Three measurements were taken and averaged together. A higher number represents a longer tear film break up time. | Day 7, 16 hours after lens insertion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myopia, Contact Lenses