A Comparison of Two Daily Disposable Contact Lenses

Study Overview
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Brief Summary
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This study seeks to evaluate the clinical performance of a recently improved daily disposable contact lens to an established daily disposable contact lens that contains a wetting agent.

Official Title
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The Comparative Clinical Performance of the Etafilcon A Lens and the DAILIES AquaComfort Plus Lens

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: 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 with 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 successfully worn 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 oedema, corneal vascularisation, 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 have taken part in any other clinical trial or research, within two weeks prior to starting this study.

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 |
| --- | --- |
| Other: etafilcon A first nelfilcon A second<br>etafilcon A worn daily during week 1, nelfilcon A worn daily for week 2 | Device: etafilcon A<br>* contact lens worn daily for one week (first or second week depending on arm)<br>* Other names: 1-DAY ACUVUE MOIST;Device: nelfilcon A<br>* Contact lens worn daily for one week (first or second week depending on arm)<br>* Other names: DAILIES AquaComfort Plus;|
| Other: nelfilcon A first, etafilcon A second<br>nelfilcon A worn daily during week 1, etafilcon A worn daily for week 2 | Device: etafilcon A<br>* contact lens worn daily for one week (first or second week depending on arm)<br>* Other names: 1-DAY ACUVUE MOIST;Device: nelfilcon A<br>* Contact lens worn daily for one week (first or second week depending on arm)<br>* Other names: DAILIES AquaComfort Plus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | Measured using high contrast and low contrast vision charts without the use of spectacles (glasses) or refraction equipment (for contact lens wearers). Values are on the logMar scale where lower values (< 0) refer to 'better' values of sight. These scores are converted from a Snellen eye chart examination. | 2-week | 
| Subjective Lens Comfort | Subjects were asked to rate lens performance on a scale of 0 to 100 point scale (0= Extremely poor or Cannot use lenses and 100= Excellent or Highly impressed with these lenses overall). The average score is reported. A factor analysis was used to identify the questions pertaining to product performance, a factor loading of 0.4 or greater was used. | 2-week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject-reported Overall Product Performance | Subjects were asked to rate lens performance on a scale of 0 to 100 point scale (0= Extremely poor or Cannot use lenses and 100= Excellent or Highly impressed with these lenses overall). The average score is reported. A factor analysis was used to identify the questions pertaining to product performance, a factor loading of 0.4 or greater was used. | 2-week | 
| Optimum Lens Fit | Number of subjects that measured as an optimum fit. Lens fit will be assessed using the following evaluations: horizontal and vertical centration, corneal coverage and movement. Normally, for an acceptable fit, centration and movement will fall within currently accepted clinical criteria [between -1 and +1 on a -2 to +2 grading scale. | Baseline, 1-week, 2-week |