Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses

Study Overview
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Brief Summary
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The purpose of this crossover study was to evaluate the end-of-day comfort of two commercially available, daily disposable, silicone hydrogel contact lenses.

Official Title
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Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses

Conditions
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Myopia

Intervention / Treatment
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* Device: Delefilcon A contact lenses
* Device: Narafilcon A contact lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign written Informed Consent Document. Currently wearing soft contact lenses in both eyes and identified as symptomatic based on questionnaire responses. Currently wearing either daily disposable contact lenses or weekly/monthly replacement contact lenses. Able to achieve visual acuity of at least 6/7.5 in each eye with study lenses in the available parameters. Willing to wear study lenses for at least eight hours per day and at least five days per week. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Has not worn contact lenses before. Currently wearing DAILIES TOTAL1 or 1-DAY ACUVUE TRUEYE contact lenses. Any systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study. Ocular surgery/trauma within the last six months. Topical ocular or systemic use of antibiotics within seven days of enrollment. Pregnant or nursing women. 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: DAILIES TOTAL1, then TRUEYE<br>Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks. | Device: Delefilcon A contact lenses<br>* CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two<br>* Other names: DAILIES TOTAL1®;Device: Narafilcon A contact lenses<br>* CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two<br>* Other names: 1-DAY ACUVUE® TRUEYE™;|
| Other: TRUEYE, then DAILIES TOTAL1<br>Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks. | Device: Delefilcon A contact lenses<br>* CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two<br>* Other names: DAILIES TOTAL1®;Device: Narafilcon A contact lenses<br>* CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two<br>* Other names: 1-DAY ACUVUE® TRUEYE™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End-of-day Comfort | End-of-day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective measurement of two weeks of wear. Participants were asked, Please rate the study lenses you have been wearing the in the following area: End-of-day comfort and recorded their response on a continuous 1-10 Likert scale (1=poor and 10=excellent). | Week 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myopia, DAILIES TOTAL1, contact lenses