A Prospective Study of Two Daily Disposable Contact Lenses

Study Overview
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Brief Summary
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The purpose of this study was to evaluate the performance of a novel silicone hydrogel contact lens, DAILIES TOTAL1® (DT1) compared to the standard hydrogel material in 1-DAY ACUVUE® MOIST® (1DAVM) contact lens in contact lens wearers identified as having contact lens-related dryness symptoms.

Detailed Description
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Three study visits occurred over the course of 28 ± 3 days.

Official Title
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Impact of a Novel Silicone Hydrogel in Reducing Contact Lens-Related Dryness Symptoms in Existing Contact Lens Wearers

Conditions
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Myopia

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


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 and HIPAA form. Currently wearing soft contact lenses and identified as having contact lens-related dryness symptoms based upon responses to the Contact Lens Dry Eye Questionnaire. Wearing either daily disposable contact lenses or bi-weekly/monthly replacement contact lenses, daily wear use only (no extended wear use). Able to achieve distance visual acuity of at least 20/25 in each eye with study lenses in the available parameters, -0.50D to -6.00D. Willing to wear study lenses for at least 8 hours/day and at least 5 days/week. Willing and able to follow instructions and maintain the appointment schedule. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Neophyte or current wearer of DAILIES TOTAL1® or 1-DAY ACUVUE® MOIST™ contact lenses. Requires monovision or presbyopic correction. Any systemic or ocular disease or disorder complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study. Recent (within 7 days of enrollment) or current ocular infection, active ocular inflammation, glaucoma or preauricular lymphadenopathy. Clinically significant lash or lid abnormality. Systemic disease that, in the investigator's best judgment, would prohibit or confound safe contact lens wear. History of ocular surgery/trauma within the last 6 months. Topical or systemic antibiotics use within 7 days of enrollment. Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 43 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DT1<br>Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks | Device: Delefilcon A contact lenses<br>* Silicone hydrogel contact lenses for daily wear, daily disposable use<br>* Other names: DAILIES TOTAL1®;|
| Active Comparator: 1DAVM<br>Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks | Device: Etafilcon A contact lenses<br>* Hydrogel contact lenses for daily wear, daily disposable use<br>* Other names: 1-DAY ACUVUE® MOIST™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ | Contact lens symptoms were evaluated using the Contact Lens and Dry Eye Questionnaire (CLDEQ). The participant indicated the frequency with which 9 common contact lens-related ocular surface dryness symptoms were experienced over the previous week. Each symptom was rated on a 5-point scale (1=never, 5=constantly). Both eyes contributed to the mean. A more negative change number indicates a greater perceived improvement, namely, lessening of the symptom. | Day 0, Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myopia, contact lenses, dry eyes, comfort, replacement