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 new CE marked daily disposable contact lens that contains a wetting agent to a recently improved daily disposable contact lens.

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

Conditions
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Refractive Error, Myopia

Intervention / Treatment
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* Device: nelfilcon 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: nefilcon A<br>Subjects randomized to this arm received the nelfilcon A lens throughout the entire duration of the study. | Device: nelfilcon A<br>* contact lens<br>* Other names: FOCUS DAILIES AquaComfort Plus;|
| Experimental: narafilcon A<br>Subjects randomized to this arm received the narafilcon A lens throughout the entire duration of the study. | Device: narafilcon A<br>* contact lens<br>* Other names: Experimental Contact Lens;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort at the End of the Day | Comfort at the end of the day was assessed by the individual questionnaire item Comfort at the end of the day with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. EOD Comfort was also assessed by the individual item How comfortable did your eyes feel at the end of the day when wearing the contact lenses you were provided? with the respopnse categories of 1=Extremely Uncomfortable, 2=Very Uncomfortable, 3=Slightly Uncomfortable, 4=Comfortable and 5= Very Comfortable. The number of participants that responsed in each cateogry for each item was reported. | 1-Week Follow-up | 
| Limbal Hyperaemia | Limbal Hyperaemia was measured using Efron Grading Scale ranges from 0 to 4 with 0.5 units increments (0 = Normal, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe). | 1-Week Follow-up | 
| Comfort Immediately When You First Put Them on | Comfort immediately when you first put them on was assessed by the individual questionnaire item Comfort immediately when you first put them on with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported. | 1-Week Follow-up | 
| Comfort Throughout the Day | Comfort throughout the day was assessed by the individual questionnaire item Comfort throughout the day with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported. | 1-Week Follow-up | 
| Lack of Dryness at the End of the Day | Lack of dryness at the end of the day was assessed by the individual questionnaire item Not making your eyes feel dry even at the end of the day with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported. | 1-Week Follow-up | 
| Overall Opinion | Overall opinion was assessed by the individual questionnaire item Considering your experience with the contact lenses you were provided, which statement best describes your overall opinion of these contact lenses?  with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported. | 1-Week Follow-up | 
| Overall Comfort | Overall comfort was assessed by the individual questionnaire item Overall Comfort with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported. | 1-Week Follow-up | 
| My Lenses Stayed Moist | My Lenses Stayed Moist was assessed by the individual questionnaire item They stayed moist and smooth, even after long hours at the computer with the response cateogries 1=Disagree Strongly, 2=Disagree Somewhat, 3=Neither Agree Nor Disagree, 4=Very Somewhat and 5=Agree Strongly. The number of participants that responsed in each cateogry was reported. | 1-Week Follow-up | 
| I Forgot i Was Wearing Lenses Was | I forgot i was wearing lenses was assessed by the individual questionnaire item They made me forget that I was wearing contact lenses with the response cateogries 1=Disagree Strongly, 2=Disagree Somewhat, 3=Neither Agree Nor Disagree, 4=Very Somewhat and 5=Agree Strongly. The number of participants that responsed in each cateogry was reported. | 1-Week Follow-up | 
| Mainted Natural Moisture | Mainted natural moisture was assessed by the individual questionnaire item They maintained my eyes' own natural moisture with the response cateogries 1=Disagree Strongly, 2=Disagree Somewhat, 3=Neither Agree Nor Disagree, 4=Very Somewhat and 5=Agree Strongly. The number of participants that responsed in each cateogry was reported. | 1-Week Follow-up | 
| Comfort While Wearing Lenses in Heat/Air Conditioned Environments | Comfort while wearing lenses in heat/air conditioned environments was assessed by the individual questionnaire item How often are you comfortable while sitting under or near an air conditioning vent or heating vent  with the response cateogries 0=Not Applicable, 1=Always, 2=Frequently, 3=Occasionally, 4=Rarely and 5=never. The number of participants that responsed in each cateogry was reported. | 1-Week Follow-up | 
| Dryness at the End of the Day | Dryness at the end of the day was assessed by the individual questionnaire item How dry did your eyes feel at the end of the day when wearing the contact lenses you were provided with the response cateogries 1=Extremely Dry, 2=Very Dry, 3=Moderately Dry, 4=Slightly Dry and 5=Not Dry at All. The number of participants that responsed in each cateogry was reported. | 1-Week Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Handling | Handling was assessed through opinion of handling in the final questionnaire. There were 5 categories Excellent (5), Very Good (4), Good (3), Fair (2) and Poor (1). | 1-Week Follow-up |