The Clinical Evaluation 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: omafilcon A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: They are of legal age (18 years) and capacity to volunteer. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent. They are willing and able to follow the protocol. They would be expected to attain at least 6.9 (20/30) in each eye with the study lenses. They are able to wear contact lenses which have a back vertex power of -1.00 to -6.00DS. They have a maximum of 1.00D of refractive astigmatism (i.e. < 1.00 DC). They have worn soft contact lenses within six months of starting the study. Exclusion Criteria: They have an ocular disorder which would normally contra-indicate contact lens wear. They have a systemic disorder which would normally contra-indicate contact lens wear. They are using any topical medication such as eye drops or ointment. They are aphakic. They have had corneal refractive surgery. They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus. They are pregnant or lactating. They have grade 2 or greater of any of the following ocular surface signs: corneal edema, corneal vascularization, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear. They have any infectious disease (e.g., hepatitis) or any immunosuppressive disease (e.g., HIV). They have diabetes. They are currently taking part in any other clinical study or research.

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: etafilcon A/etafilcon A<br>Period 1: etafilcon A, Period 2: etafilcon A | Device: etafilcon A<br>* contact lens<br>|
| Active Comparator: etafilcon A/omafilcon A<br>Period 1: etafilcon A, Period 2: omafilcon A | Device: etafilcon A<br>* contact lens<br>Device: omafilcon A<br>* contact lens<br>|
| Active Comparator: omafilcon A/etafilcon A<br>Period 1: omafilcon A, Period 2: etafilcon A | Device: etafilcon A<br>* contact lens<br>Device: omafilcon A<br>* contact lens<br>|
| Active Comparator: omafilcon A/omafilcon A<br>Period 1: omafilcon A, Period 2: omafilcon A | Device: omafilcon A<br>* contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance Visual Acuity | logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Comfort | A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control.>0 = comfortable, <0 = uncomfortable | 1 week |