Comparison of Two Daily Disposable Soft Contact Lenses

Study Overview
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Brief Summary
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The aim of this study was to investigate the short-term clinical performance and subjective acceptance of the two study lenses.

Detailed Description
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This study was a randomised, double-masked, crossover, bilateral dispensing study, controlled by cross-comparison. Fifty-five subjects will wear each lens brand for approximately one week in random order. Lenses were worn on a daily wear, daily disposable basis.

Official Title
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A Clinical Comparison of Two Daily Disposable Soft Contact Lenses

Conditions
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Astigmatism Bilateral

Intervention / Treatment
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* Device: midafilcon A
* Device: somofilcon A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: They are between 18 and 40 years of age (inclusive). 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 are an existing silicone hydrogel reusable spherical contact lens wearer in both eyes. They have a contact lens spherical prescription between -0.25D and -6.00D (inclusive) based on ocular refraction. They own a wearable pair of spectacles and wear them on the day of the initial visit. At dispensing, they can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range. They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day). They agree not to participate in other clinical research for the duration of 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, or use any rewetting/lubricating drops whilst on this study. They are aphakic. They have had corneal refractive surgery. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. They are pregnant or breastfeeding. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction. They have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Active Comparator: midafilcon A<br>Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study. | Device: midafilcon A<br>* midafilcon A 1 day daily disposable contact lens<br>|
| Active Comparator: somofilcon A<br>Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study. | Device: somofilcon A<br>* somofilcon A 1 day daily disposable contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Fit - Horizontal Centration | Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal) | Baseline | 
| Lens Fit - Horizontal Centration | Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal) | One Week | 
| Lens Fit - Vertical Centration | Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior) | Baseline | 
| Lens Fit - Vertical Centration | Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior) | One Week | 
| Lens Fit - Corneal Coverage | Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive) | Baseline | 
| Lens Fit - Corneal Coverage | Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive) | One Week | 
| Lens Fit - Lens Movement | Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive) | Baseline | 
| Lens Fit - Lens Movement | Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive) | One Week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Score for Vision | Subjects will score on visual analogue scale for vision (0 -100) (0 - Unacceptable, 20 - Very poor, 40 - Poor, 60 - Good, 80 - Very Good, 100 - Excellent) | Baseline | 
| Subjective Score for Vision | Subjects will score on visual analogue scale for Vision (0 -100) (0 - Unacceptable, 20 - Very poor, 40 - Poor, 60 - Good, 80 - Very Good, 100 - Excellent) | One week |