Clinical Evaluation of a Daily Disposable Contact Lens in Symptomatic Weekly/Monthly Lens Wearers

Study Overview
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Brief Summary
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The purpose of this study was to evaluate the reduction of contact lens-related dryness symptoms when symptomatic weekly/monthly contact lens wearers were switched to DAILIES® AquaComfort Plus® lenses for a two-week period using composite scores on the Contact Lens Dry Eye Questionnaire (CLDEQ).

Official Title
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Clinical Evaluation of a Daily Disposable Contact Lens in Symptomatic Weekly/Monthly Lens Wearers

Conditions
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Myopia, Dry Eye Syndrome

Intervention / Treatment
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* Device: Nelfilcon A contact lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Currently wearing weekly/monthly, silicone hydrogel or traditional hydrogel soft contact lenses at least 8 hours per day and 5 days a week during the past 6 months. Identified as symptomatic using a baseline screening questionnaire. Requires vision correction in both eyes with a contact lens prescription as follows: sphere powers between -0.50 and -10.00 diopter (D) and cylinder powers </= 0.75D and no ADD correction. Able to achieve visual acuity (VA) of at least 6/7.5 in each eye with study lenses in the available parameters. Willing to wear study lenses for at least 8 hours/day and at least 5 days/week and discard the lenses at the end of the day and replace lenses every day with a new fresh pair. Willing and able to follow instructions and maintain the appointment schedule. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Neophytes and current wearers of daily disposable contact lenses. Requires monovision correction. Any systemic or ocular disease or disorder (refractive disorder allowed) complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study. A history of ocular surgery/trauma within the last 6 months. Unwilling to discontinue mechanical eyelid therapy or eyelid scrubs within 14 days of enrollment and continuing during the study. 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DAILIES® AquaComfort Plus®<br>Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks | Device: Nelfilcon A contact lenses<br>* Commercially marketed hydrogel contact lenses for daily wear, daily disposable use<br>* Other names: DAILIES® AquaComfort Plus®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Contact Lens-Related Dryness Symptoms at Week 1 and Week 2 | Contact lens symptoms were evaluated using the Contact Lens Dry Eye Questionnaire (CLDEQ). Subjects rated 8 common contact lens-related ocular surface dryness symptoms at Baseline, Week 1, and Week 2 using a 5-point scale (1=never or not at all intense, 5=constantly or very intense). A scoring algorithm was used to calculate a composite score for each visit for all symptoms (-6.5 to 10). A higher composite score would indicate more contact lens related dry eye and a lower score, less contact lens related dry eye. | Baseline, Week 1, Week 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contact lens, dry eye syndrome, symptomatic, daily disposable, myopia