Multi-center Clinical Evaluation of PC 1-Day vs 1-Day Acuvue Moist

Study Overview
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Brief Summary
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The objective of this study is to compare the clinical performance of ProClear 1-Day versus 1-Day Acuvue Moist each for one week of daily disposable wear.

Detailed Description
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The purpose of this cross-over study is to evaluate the clinical performance of the ProClear-1 Day in comparison with 1-Day Acuvue® Moist®. In particular, the study will focus on lens wearing comfort.

Official Title
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Multi-center Clinical Evaluation of PC 1-Day vs 1-Day Acuvue Moist

Conditions
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Myopia

Intervention / Treatment
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* Device: omafilcon A
* Device: etafilcon A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A person is eligible for inclusion in the study if he/she: Is between 18 and 40 years of age (inclusive) Have the use of a mobile phone to send and receive text messages throughout the day for the duration of the study. Has had a self-reported visual exam in the last two years Is an adapted soft CL (Contact Lens) wearer Must be able to wear their lenses at least 6 full days over the 7 days; 14 hours per day, assuming there are no contraindications for doing so Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive) Has less than 0.75D (Diopters) spectacle cylinder in each eye. Is correctable to a visual acuity of 20/25 or better in both eyes Has clear corneas and no active ocular disease Has read, understood and signed the information consent letter. Is willing to comply with the wear schedule (at least 40 hrs per week) Is willing to comply with the visit schedule Exclusion Criteria: A person will be excluded from the study if he/she: Has never worn contact lenses before. Currently wears rigid gas permeable contact lenses. Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day) Has a CL prescription outside the range of - 1.00 to -6.00D Has a spectacle cylinder greater than -0.50D of cylinder in either eye. Has best corrected spectacle distance vision worse then 20/25 in either eye. Has any systemic disease affecting ocular health. Is using any systemic or topical medications that will affect ocular health. Has any ocular pathology or severe insufficiency of lacrimal secretion Has persistent, clinically significant corneal or conjunctival staining Has active neovascularization or any central corneal scars. Is aphakic. Is presbyopic. Has undergone corneal refractive surgery. Is participating in any other type of eye related clinical or research study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| Active Comparator: omafilcon A<br>Study participants are randomized to wear omafilcon A lenses. | Device: omafilcon A<br>* contact lens<br>* Other names: Proclear 1 Day (omafilcon A);|
| Active Comparator: etafilcon A<br>Study participants are randomized to wear etafilcon A lenses. | Device: etafilcon A<br>* contact lens<br>* Other names: 1-Day Acuvue Moist (etafilcon A);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort (Subjective Assessment) | Subjective Assessment of comfort on insertion at baseline for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very uncomfortable, 10=cannot feel) | Baseline | 
| Comfort (Subjective Assessment) | Subjective Assessment: Insertion Comfort, Comfort During Day, Comfort Prior to Removal, Comfort Overall for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very uncomfortable, 10=cannot feel) | 1 Week | 
| Hydration (Subjective Assessment) | Subjective Assessment of hydration on insertion at baseline for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dehydrated, not hydrophilic, very dry, 10=very hydrated, ultra hydrophilic) | Baseline | 
| Hydration (Subjective Assessment) | Subjective Assessment: Initial Hydration, Hydration During Day, Hydration Prior to Removal for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dehydrated, not hydrophilic, very dry, 10=very hydrated, ultra hydrophilic) | 1 Week | 
| Vision Quality (Subjective Assessment) | Subjective Assessment: Visual quality on insertion at baseline for each pair using questionnaire and rated on subjective response scale (0-10; 0= clear vision, 10=perfectly sharp) | Baseline | 
| Vision Satisfaction (Subjective Assessment) | Subjective Assessment: Vision Satisfaction for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very unsatisfied, 10=very satisfied) | 1 Week | 
| Dryness (Subjective Assessment) | Subjective Assessment: Dryness During Day, Dryness Prior to Removal, Overall Dryness for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dry, 10=no dryness) | 1 Week | 
| Handling (Subjective Assessment) | Subjective Assessment: Handling on Insertion and Removal, Overall Handling for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very difficult, 10=very easy) | 1 Week | 
| Eye Whiteness/Redness (Subjective Assessment) | Subjective Assessment: Eye Whiteness/Redness for each pair using questionnaire and rated on subjective response scale. (0-10; 0= significant redness, 10=totally white) | 1 Week | 
| Overall Sensation of Smoothness (Subjective Assessment) | Subjective Assessment: Overall sensation of smoothness at 1 week wear for each pair when asked How would you rate the overall sensation of smoothness (deposit resistance) of the first study lenses, over the last week of wear? (Likert 1-5; 1=excellent, 2=good, 3=average, 4=below average, 5=poor) | 1 Week | 
| Overall Satisfaction for Lens | Subjective Assessment: Satisfaction overall at 1 Week wear for each pair when asked Overall, how satisfied was the subject with the study lenses, during the last week, with regards to: Overall? (Likert 1-4; 1=completely satisfied, 2=somewhat satisfied, 3=somewhat dissatisfied, 4=completely dissatisfied) | 1 Week |