A Clinical Comparison of Two Daily Disposable Soft Contact Lenses

Study Overview
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Brief Summary
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This double-masked, randomized, bilateral, crossover, direct refit study compared the clinical performance of two daily disposable contact lenses (somofilcon A and stenfilcon A) when fitted to existing wearers of comfilcon A monthly lenses.

Detailed Description
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This double-masked (subject and investigator), randomized, bilateral, crossover, direct refit study compared the clinical performance of two daily disposable test contact lenses (somofilcon A and stenfilcon A) when fitted to existing wearers of comfilcon A monthly lenses. After a month of re-useable lens wear in the comfilcon A lenses, subjects were randomized to wear each daily disposable lens type for one week.

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

Conditions
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Myopia

Intervention / Treatment
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* Device: comfilcon A
* Device: somofilcon A
* Device: stenfilcon A


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 between 18 and 40 years of age (inclusive). 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 are an existing soft reusable spherical contact lens wearer in both eyes. They have a contact lens spherical prescription between -0.50 to -6.00D (inclusive) based on the ocular refraction. They have a cylindrical correction of -0.875DC or less in each eye based on the ocular refraction They own a wearable pair of spectacles and wear them on the day of the initial visit. They have distance high contrast logMAR visual acuity of 0.2 or better in each eye with their habitual spectacles. 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. 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 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
Maximum Age: 40 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: somofilcon A then stenfilcon A contact lens<br>Participants were fitted with comfilcon A lens on a daily wear, reusable basis for 1 month, then randomized to wear somofilcon A daily disposable test lens for 1 week of daily wear and stenfilcon A daily disposable test lens for 1 week of daily wear. | Device: comfilcon A<br>* Contact Lens<br>* Other names: Control Lens;Device: somofilcon A<br>* daily disposable contact lens<br>* Other names: Test lens 1;Device: stenfilcon A<br>* daily disposable contact lens<br>* Other names: Test lens 2;|
| Experimental: stenfilcon A then somofilcon A contact lens<br>Participants were fitted with comfilcon A lens on a daily wear, reusable basis for 1 month, then randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear and somofilcon A daily disposable test lens for 1 week of daily wear. | Device: comfilcon A<br>* Contact Lens<br>* Other names: Control Lens;Device: somofilcon A<br>* daily disposable contact lens<br>* Other names: Test lens 1;Device: stenfilcon A<br>* daily disposable contact lens<br>* Other names: Test lens 2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Scores of Comfort at Insertion After 4 Weeks of Comfilcon A Use | Subjective Scores of comfort at Insertion after 4 weeks of Comfilcon A use rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt). | 4 weeks | 
| Subjective Scores of Comfort on Insertion | Subjective Scores of Comfort on Insertion rated on a scale 0 -100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt). | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Scores on Overall Comfort After 4 Weeks of Comfilcon Use | Subjective scores on overall comfort after 4 weeks of comfilcon use rated on a scale 0 -100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt). | 4 weeks | 
| Subjective Scores on Overall Comfort | Subjective Scores on overall comfort rated on a scale 0 - 100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt). | 1 week | 
| Subjective Scores on Comfort Before Removal After 4 Weeks of Comfilcon Use | Subjective Scores on Comfort before removal after 4 weeks of comfilcon use rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt). | 4 weeks | 
| Subjective Scores on Comfort Before Removal | Subjective Scores on Comfort before removal rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt). | 1 week | 
| Number of Participants With Horizontal Lens Centration Grade | Number of Participants with Horizontal Lens centration graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal) | Baseline (after 5 minutes of lens dispense) | 
| Number of Participants With Horizontal Lens Centration Grade After 4 Weeks of Comfilcon A Wear | Number of Participants with Horizontal lens centration after 4 weeks of comfilcon A wear graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal) | 4 weeks | 
| Number of Participants With Horizontal Lens Centration Grade | Number of Participants with Horizontal Lens centration graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal) | 1 week | 
| Number of Participants With Vertical Lens Centration Grade | Number of Participants with Vertical lens centration graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior) | Baseline (After 5 minutes of lens dispense) | 
| Number of Participants With Vertical Lens Centration Grade After 4 Weeks of Comfilcon A Wear | Number of Participants with Vertical lens centration after 4 weeks of comfilcon A wear graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior) | 4 weeks | 
| Number of Participants With Vertical Lens Centration Grade | Number of Participants with Vertical lens centration graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior) | 1 week | 
| Number of Participants With Lens Corneal Coverage Grade | Number of Participants with Lens Corneal coverage graded on a scale -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) | 
| Number of Participants With Lens Corneal Coverage Grade After 4 Weeks of Comfilcon A Wear | Number of Participants with Lens Corneal coverage after 4 weeks of comfilcon A wear graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive) | 4 weeks | 
| Number of Participants With Lens Corneal Coverage Grade | Number of Participants with Lens Corneal coverage graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive) | 1 week | 
| Number of Participants With Post-Blink Movement Grade | Number of Participants with Post-blink movement graded on a scale of -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) | 
| Number of Participants With Post-Blink Movement Grade After 4 Weeks of Comfilcon A Wear | Number of Participants with Post-blink movement after 4 weeks of comfilcon A wear graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive) | 4 weeks | 
| Number of Participants With Post-Blink Movement Grade | Number of Participants with Post-blink movement graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive) | 1 week | 
| Investigator Lens Fit Acceptance | Lens fit acceptance investigator rating for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree) | Baseline (after 5 minutes of lens dispense) | 
| Investigator Lens Fit Acceptance for Comfilcon A After 4 Weeks of Use | Lens fit acceptance investigator rating for comfilcon A after 4 weeks of use for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree) | 4 weeks | 
| Investigator Lens Fit Acceptance | Lens fit acceptance investigator rating for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree) | 1 week |