The Clinical Comparison of Somofilcon A 1 Day and Nelfilcon A Daily Disposable Contact Lenses

Study Overview
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Brief Summary
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This subject-masked, randomized, bilateral crossover study will compare the clinical performance and subjective acceptance of the somofilcon A 1 day soft contact lens with the nelfilcon A daily disposable lens when used on a daily wear, daily disposable basis.

Detailed Description
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This will be a randomized, subject-masked, crossover, bilateral study, controlled by cross-comparison. This will compare the clinical performance and subjective acceptance of the somofilcon A 1 day soft contact lens with the nelfilcon A daily disposable lens when used on a daily wear, daily disposable basis. 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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The Clinical Comparison of the Clariti 1 Day and DAILIES AquaComfort PLUS Daily Disposable Contact Lenses

Conditions
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Ametropia

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 (inclusive) They have a maximum of -1.00DC ocular astigmatism in each eye. They can be satisfactorily fitted with the study lens types. 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 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). They own a wearable pair of spectacles. 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 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. They currently wear either the clariti 1day or the DAILIES AquaComfort Plus lens.

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This is a bilateral crossover study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: somofilcon A, then nelfilcon A<br>Subjects will bilaterally wear the somofilcon A lenses, then crossover to nelfilcon A lenses after one week of wear. Both lenses will be worn on a daily wear basis for one week. | Device: somofilcon A<br>* Contact Lens<br>* Other names: clariti 1 day;Device: nelfilcon A<br>* Contact Lens<br>* Other names: DAILIES AquaComfort PLUS daily disposable;|
| Experimental: nelfilcon A, then somofilcon A<br>Subjects will bilaterally wear the nelfilcon A lenses, then crossover to somofilcon A lenses after one week of wear. Both lenses will be worn on a daily wear basis for one week. | Device: somofilcon A<br>* Contact Lens<br>* Other names: clariti 1 day;Device: nelfilcon A<br>* Contact Lens<br>* Other names: DAILIES AquaComfort PLUS daily disposable;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Comfort at Lens Dispensing | Subjective comfort at lens dispensing on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.). | Baseline (after 5 minutes of lens dispense) | 
| Subjective Comfort at Start of Day | Subjective comfort at start of day on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.). | 1 week | 
| Subjective Comfort at End of Day | Subjective comfort at end of day on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.). | 1 week | 
| Overall Subjective Comfort | Overall subjective comfort on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.). | Baseline (after 5 minutes of lens dispense) | 
| Overall Subjective Comfort | Overall subjective comfort on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.). | 1 week | 
| Subjective Vision | Subjective Vision rated on scale 0-100 (0=unacceptable, lens cannot be worn to 100=excellent, unaware of an visual loss.) | Baseline (after 5 minutes of lens dispense) | 
| Subjective Vision | Subjective Vision rated on scale 0-100 (0=unacceptable, lens cannot be worn to 100=excellent, unaware of an visual loss.) | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomicroscopy - Conjunctival Redness Score | Conjunctival redness - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). | One Week | 
| Biomicroscopy - Limbal Redness Score | Limbal redness - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). | One week | 
| Biomicroscopy - Corneal Staining Score | Corneal staining - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). | One week | 
| Biomicroscopy - Conjunctival Staining Score | Conjunctival staining - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). | One week | 
| Biomicroscopy - Papillary Conjunctivitis Score | Papillary conjunctivitis- slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). | One week | 
| Horizontal Centration - Lens Fit | Horizontal centration graded by -2 to 2 (-2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal). | Baseline (after 5 minutes of lens dispense) | 
| Horizontal Centration - Lens Fit | Horizontal centration graded by -2 to 2 (-2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal). | One Week | 
| Vertical Centration Grade - Lens Fit | Vertical centration graded by -2 to 2 (-2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior). | Baseline (after 5 minutes of lens dispense) | 
| Vertical Centration Grade - Lens Fit | Vertical centration graded by -2 to 2 (-2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior). | One week | 
| Corneal Coverage Grade | Corneal coverage graded by -2 to 2 (-2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive). | Baseline (after 5 minutes of lens dispense) | 
| Corneal Coverage Grade | Corneal coverage graded by -2 to 2 (-2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive). | One week | 
| Post-Blink Movement Grade | Post-blink movement graded by -2 to 2 (-2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive). | Baseline (after 5 minutes of lens dispense) | 
| Post-Blink Movement Grade | Post-blink movement graded by -2 to 2 (-2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive). | 1 week | 
| Ocular Redness Rating | Ocular redness rating rated on a scale 0-100 (0=extremely poor, intolerable levels of redness to 100 = excellent, no redness) | 1 week |