Clinical Performance of a New Daily Disposable Contact Lens Worn in an Established Contact Lens Wearing Population

Study Overview
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Brief Summary
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This study seeks to evaluate the clinical and subjective performance of a new daily disposable soft contact lens.

Conditions
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Myopia, Refractive Error

Intervention / Treatment
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* Device: Habitual Silicone Hydrogel Contact Lens
* Device: narafilcon A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: They are of legal age (17 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: 17 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Habitual silicone hydrogel<br>Habitual contact lens wear. | Device: Habitual Silicone Hydrogel Contact Lens<br>* contact lens<br>|
| Experimental: narafilcon A<br>Silicone hydrogel daily disposable contact lens | Device: narafilcon A<br>* contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Limbal Hyperemia | Measures the redness of the limbal region of the eye on a scale of 0 to 100 grade with 0=none and 100=severe. The analysis is the average grade over all time frames. | At 2 weeks and 4 weeks | 
| Lens Comfort | Rating of lens comfort by rating agreement to the following statement: The lenses I am wearing are comfortable. Rating using the following scale: 1=strongly agree, 2=agree, 3=neutral, 4=disagree, 5=strongly disagree. The rating is averaged over all time frames. | At 3,7,10,13,17,21,24, and 27 days | 
| Upper Lid Margin Staining | Measures the trauma to tissue that lines the margin of the inside of the upper eyelid on a 0 to 3 scale, with 0=none to 3=severe. The analysis is the average grade over all time frames. | At 2 weeks and 4 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tarsal Roughness | Measures the amount of roughness to the tissue of the inside upper and lower eyelid on a scale of 0 to 100 with 0=none and 100=severe. The analysis is the average grade over all time frames. | At 2 weeks and 4 weeks | 
| Tarsal Hyperemia | Measures the amount of redness to the tissue of the inside upper and lower eyelid using a 0 to 100 scale with 0=none and 100=severe. | At 2 weeks and 4 weeks. | 
| Corneal Staining | A measure of corneal abrasion using a 0 to 100 scale with 0=none, 25=micropunctate, 50=macropunctate, 75=coalescence, 100=patch. The analysis is the average grade over all time frames. | At 2 weeks and 4 weeks. |