A Clinical Comparison of Two Daily Disposable Contact Lenses.

Study Overview
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Brief Summary
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The objective of this study is to evaluate the clinical performance of two daily disposable contact lenses.

Conditions
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Myopia

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18 years to 45 years Current daily soft contact lens as habitual optical correction: Refraction: Best sphere (corrected for back vertex distance) -1.00 to -6.00D Cylinder 0.00 to - 0.75D Best spectacle corrected visual acuity of 6/9 or better in each eye Willingness to adhere to the instructions set in the clinical protocol Signature of the subject on the informed consent form Exclusion Criteria: Systemic or ocular allergies which might interfere with contact lens wear Systemic disease which might interfere with contact lens wear Ocular disease which might interfere with contact lens wear (e.g. hypoesthesia, insufficient lacrimal secretion) Use of medication which might interfere with contact lens wear Active ocular infection Use of ocular medication Significant ocular anomaly Presence of two or more corneal scars in either eye Pregnancy or lactation Any medical condition that might be prejudicial to the study Participated in any other clinical studies in the past month Currently wears monovision

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: etafilcon A/nelfilcon A<br>etafilcon A contact lens worn first and nelfilcon A contact lens worn second | Device: etafilcon A<br>* Contact Lens<br>Device: nelfilcon A<br>* Contact Lens<br>|
| Active Comparator: nelfilcon A/etafilcon A<br>nelfilcon A contact lens worn first and etafilcon A contact lens second. | Device: etafilcon A<br>* Contact Lens<br>Device: nelfilcon A<br>* Contact Lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Comfort | Subjects rated study contact lens for overall comfort using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inferior Region Corneal Staining | The investigator assessed abrasion to the lower portion of the cornea using the following scale:0 = None 1 = Slight micropunctate (1-10 spots) 2 = Moderate micropunctate (11-20 spots) 3 = Severe micropunctate (>20 spots)4 = Slight macropunctate (1-5 spots) 5 = Moderate macropuntate (>5-10 spots) 6 = Severe macropunctate (>10 spots) 7 = Slight patch (1-2mm)8 = Moderate patch (>2-4mm) 9 = Severe patch (>4mm) | 1 week | 
| End of the Day Comfort | Subjects rated study contact lens comfort at the end of a day of lens wear using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor. | 1 week | 
| Initial Comfort | Subjects rated study contact lens for comfort immediately when they first put the lenses on using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor. | 1 Week | 
| Overall Lens Handling | Subjects rated study contact lens for overall ease of handling using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor. | 1 week |