Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Lens Wearers

Study Overview
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Brief Summary
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The purpose of this trial is to evaluate the extent to which symptoms improve in symptomatic contact lens wearers when fit with one of 5 different daily disposable contact lenses.

Conditions
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Myopia

Intervention / Treatment
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* Device: Nelfilcon A contact lens
* Device: Narafilcon A contact lens
* Device: Etafilcon A contact lens
* Device: Omafilcon A contact lens
* Device: Hilafilcon B contact lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Currently wear spherical, soft contact lenses replaced at intervals of 2 weeks or monthly. Habitually wear lenses for at least 8 hours per day, 4 days per week, for at least the past 6 months. Report 2 or more qualifying symptoms with current contact lenses with a frequency of frequently or all the time Able to achieve VA of at least 20/40 in each eye with habitual correction and with study lenses at dispense. Other protocol inclusion/exclusion criteria may apply. Exclusion Criteria: Eye injury or surgery within twelve weeks immediately prior to enrollment. Currently enrolled in any clinical trial. Any use of medications for which contact lens wear could be contraindicated as determined by the investigator. History of corneal refractive surgery. Cylinder correction greater than 1.00 D. Current monovision contact lens wearers. Other protocol inclusion/exclusion criteria may apply.
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: Nelfilcon A<br>Nelfilcon A contact lens | Device: Nelfilcon A contact lens<br>* Daily disposable contact lens worn in a daily wear, daily disposable mode<br>|
| Active Comparator: Narafilcon A<br>Narafilcon A contact lens | Device: Narafilcon A contact lens<br>* Daily disposable contact lens worn in a daily wear, daily disposable mode<br>|
| Active Comparator: Etafilcon A<br>Etafilcon A contact lens | Device: Etafilcon A contact lens<br>* Daily disposable contact lens worn in a daily wear, daily disposable mode<br>|
| Active Comparator: Omafilcon A<br>Omafilcon A contact lens | Device: Omafilcon A contact lens<br>* Daily disposable contact lens worn in a daily wear, daily disposable mode<br>|
| Active Comparator: Hilafilcon B<br>Hilafilcon B contact lens | Device: Hilafilcon B contact lens<br>* Daily disposable contact lens worn in a daily wear, daily disposable mode<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Awareness | Lens awareness, as interpreted by the subject, was reported by the subject as a single, retrospective evaluation of 4 week's wear time. Frequency of lens awareness was measured on a 4-point scale, with 1 being never and 4 being all the time. Four-week ratings were compared to baseline ratings, and a negative difference (4-week minus baseline) represented an improvement. | 4 weeks of wear |