Clinical Performance of a New Daily Disposable Contact Lens Worn in a Neophyte Population.

Study Overview
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Brief Summary
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This study seeks to evaluate the impact of wearing a new daily disposable soft contact lens on the neophyte population.

Official Title
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Clinical Performance of a New Daily Disposable Contact Lens Worn in a Neophyte Population.

Conditions
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Myopia, Refractive Error

Intervention / Treatment
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* Device: spectacles
* Device: narafilcon A soft contact lenses


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: 39 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 |
| --- | --- |
| Other: spectacles<br>habitual spectacles worn daily for 12 months | Device: spectacles<br>* habitual spectacles<br>|
| Experimental: narafilcon A soft contact lenses<br>narafilcon A soft contact lenses worn as daily disposable for 12 months | Device: narafilcon A soft contact lenses<br>* narafilcon A daily disposable contact lenses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Papillary Conjunctivitis | Papillary conjunctivitis which is collected as part of the biomicroscopy data and is identified from a slit lamp examination. Grade 0 to Grade 4 with grade 0 implying no health concerns. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomicroscopy Findings After 12 Months of Daily Wear From Slit Lamp Analysis. | Comprised of 8 categories (conjunctival hyperemia, limbal hyperemia, corneal vascularization, microcysts, Oedema, corneal staining, conjunctival staining and papillary conjunctivitis) each scored on a scale of 0 to 4 where 0=none, and 4=maximum score for each category. | at 12 months | 
| Visual Acuity After 12 Months of Wear | Visual acuity is measured at high and low contrasts, via the Snellen scale which is then mathematically converted to logMar units. High contrast refers to a darker print on the Snellen chart and is an easier testing environment compared to the low contrast which has a grayer print. | at 12 months | 
| Subjective Overall Comfort After 12 Months of Daily Wear | subject response using a scale of 0 to 100, where 0 = poor comfort, 100 = excellent comfort | at 12 months | 
| Subjective Overall Vision After 12 Months of Daily Wear | subject response using a scale of 0 to 100, where 0 = poor vision, 100 = excellent vision | at 12 months |