A Clinical Comparison of Three Soft Daily Disposable Contact Lenses

Study Overview
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Brief Summary
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This study aims to compare the clinical performance of the somfilcon A, nelfilcon A II 2 and omafilcon A II 2 daily disposable contact lenses.

Detailed Description
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This will be a randomised, subject-masked, crossover, bilateral study, controlled by cross comparison. Fifty subjects will use each lens type for a week in random sequence. Follow-up visits for each lens will be performed after one week of wear. Lenses will be worn on a daily wear, daily disposable wear schedule.

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

Conditions
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Myopia

Intervention / Treatment
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* Device: somofilcon A
* Device: nelfilcon A II 2
* Device: omafilcon A ll 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects will only be eligible for the study if: They are of legal age (18) and capacity to volunteer. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent. They are willing and able to follow the protocol. They agree not to participate in other clinical research for the duration of this study. They have a contact lens spherical prescription between -1.00 to - 6.00D (Diopters) (inclusive) They have a spectacle cylindrical correction of -0.75D or less in each eye. At dispensing, they can attain at least 0.10 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range. They currently use soft contact lenses or have done so in the previous six months. They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day). Exclusion Criteria: Subjects will not be eligible to take part in the study if: 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 have had cataract surgery. 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 breast-feeding. 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 other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: somofilcon A<br>Subjects are randomized to wear somofilcon A for one week during the cross over study. | Device: somofilcon A<br>* contact lens<br>|
| Active Comparator: nelfilcon A II 2<br>Subjects are randomized to wear nelfilcon A II 2 for one week during the cross over study. | Device: nelfilcon A II 2<br>* contact lens<br>|
| Active Comparator: omafilcon A ll 2<br>Subjects are randomized to wear omafilcon A ll 2 for one week during the cross over study. | Device: omafilcon A ll 2<br>* contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Physiology | Ocular physiology assessment of by biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe). | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Fit - Horizontal Centration | Horizontal centration will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal. | 1 week | 
| Lens Fit - Vertical Centration | Vertical centration will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal. | 1 week | 
| Lens Fit - Corneal Coverage | Corneal coverage will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal. | 1 week | 
| Lens Fit - Movement | Lens movement assessed using the following evaluations: extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive. | 1 week | 
| Lens Surface - Deposition | Lens surface will be assessed using Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe | 1 week | 
| Lens Surface - Wettability | Lens wettability will be assessed using Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe | 1 week | 
| Visual Acuity | Visual acuity will be assessed by LogMAR. | 1 week |