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 fitting performance of a new daily disposable contact lens to an existing daily disposable contact lens.

Official Title
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An Evaluation of the Lens Fit of Narafilcon A Soft Contact Lenses

Conditions
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Refractive Error, Myopia

Intervention / Treatment
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* Device: etafilcon A
* Device: narafilcon 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
Maximum Age: 60 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: narafilcon A / etafilcon A - etafilcon A - narafilcon A<br>First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A contact lenses worn in both eyes. | Device: etafilcon A<br>* contact lens<br>* Other names: 1-Day Acuvue Moist;Device: narafilcon A<br>* contact lens<br>* Other names: TruEye;|
| Experimental: narafilcon A / etafilcon A - narafilcon A - etafilcon A<br>First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, narafilcon A contact lenses worn in both eyes. Third, etafilcon A contact lenses worn in both eyes. | Device: etafilcon A<br>* contact lens<br>* Other names: 1-Day Acuvue Moist;Device: narafilcon A<br>* contact lens<br>* Other names: TruEye;|
| Experimental: narafilcon A - etafilcon A - narafilcon A / etafilcon A<br>First, narafilcon A contact lenses worn in both eyes. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally. | Device: etafilcon A<br>* contact lens<br>* Other names: 1-Day Acuvue Moist;Device: narafilcon A<br>* contact lens<br>* Other names: TruEye;|
| Experimental: etafilcon A - narafilcon A - narafilcon A / etafilcon A<br>First, etafilcon A contact lenses worn in both eyes. Second, narafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally. | Device: etafilcon A<br>* contact lens<br>* Other names: 1-Day Acuvue Moist;Device: narafilcon A<br>* contact lens<br>* Other names: TruEye;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Eyes Successfully Fit | Overall lens fit acceptance was assessed by the Investigator based on lens fit alone in a 6-level scale; 0=should not be worn, 1=should not be dispensed although no immediate danger, 2=borderline but unacceptable, 3=minimal acceptable, early review, 4=not perfect but OK to dispense and 5=perfect. Lens fitting responses >2 were considered 'successful fit' while the rest of responses were considered 'unsuccessful fit'. | Within 20 minutes of lens insertion | 
| Lens Fit Decentration | Lens centration was assessed in primary gaze, diffuse white light, low-medium magnification, with graticule. Lens fit decentration with respect to visible cornea was measured to nearest 0.1mm. | Within 20 minutes of lens insertion | 
| Lens Tightness on Cornea With Manual Digit Push Up | Lens tightness on push-up assessed by digital push-up test (gentle push of the lens upward using the lower lid) with eye in primary gaze position and observing ease of push-up and speed of return to original position. Tightness is measured on a 0%-100% continuous scale where 0%=falls from cornea without lid support, 50%=optimum and 100%=no movement. | Within 20 minutes of lens insertion |