Short-Term Clinical Comparison of Two Silicone Hydrogel Daily Disposable Contact Lenses

Study Overview
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Brief Summary
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This will be a 2 period one-day, double-masked, randomized, repeated measures, non-dispensing, cross-over study where the main purpose of this study is to compare the performance of a new daily disposable silicone hydrogel lens with that of an existing similar lens.

Official Title
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Short-Term Clinical Comparison of Two Silicone Hydrogel Daily Disposable Contact Lenses

Conditions
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Visual Acuity

Intervention / Treatment
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* Device: Test 8.5BC
* Device: Test 9.0BC
* Device: Control 8.5BC
* Device: Control 9.0BC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Potential subjects must satisfy all of the following criteria to be enrolled in the study: The subject must read and sign the Informed Consent form. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. Healthy adult males or females aged 18-55 years. The subject's spherical contact lens requirement in the range +2.00 D to +4.00 D or -1.00 D to -6.00 D. The subject's refractive cylinder must be ≤1.00 D in each eye. The subject must have visual acuity best correctable to 6/9 (20/30) or better for each eye. The subject is a current soft contact lens wearer (defined as a minimum of 6 hours of DW per day, at least 5 days per week, for a minimum of 1 month prior to the study). The subject must have normal eyes (i.e., no ocular medications or infections of any type). Exclusion Criteria: Potential subjects who meet any of the following criteria will be excluded from participating in the study: Currently pregnant or lactating Any systemic disease (e.g., Sjögren's Syndrome),allergies, infectious disease (e.g., hepatitis,tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study. Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear. Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion. Extended wear contact lens correction. Any current use of ocular medication. Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.) Any greater than Grade 2 slit lamp findings (e.g., oedema, corneal neovascularisation, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale or any other ocular abnormality that may contraindicate contact lens wear. Any contact lens-related history or signs of a corneal inflammatory event, or any other ocular abnormality that would contraindicate contact lens wear. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrolment. Employee, relative or friends of employees of any ophthalmic company, or investigational clinic (e.g., Investigator, Coordinator, Technician).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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
Interventional Model Description: Contra-lateral Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C 8.5\C 9.0\T 8.5\T 9.0<br>Subjects randomized to this sequence received Control lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the first period and then received Test lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the second period. | Device: Test 8.5BC<br>* senofilcon A contact lenses with 8.5 base curve<br>Device: Test 9.0BC<br>* senofilcon A contact lenses with 9.0 base curve<br>Device: Control 8.5BC<br>* narafilcon A contact lenses with 8.5 base curve<br>Device: Control 9.0BC<br>* narafilcon A contact lenses with 9.0 base curve<br>|
| Experimental: C 9.0\C 8.5\T 9.0\T 8.5<br>Subjects randomized to this sequence received Control lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the first period and then received Test lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the second period. | Device: Test 8.5BC<br>* senofilcon A contact lenses with 8.5 base curve<br>Device: Test 9.0BC<br>* senofilcon A contact lenses with 9.0 base curve<br>Device: Control 8.5BC<br>* narafilcon A contact lenses with 8.5 base curve<br>Device: Control 9.0BC<br>* narafilcon A contact lenses with 9.0 base curve<br>|
| Experimental: T 8.5\T 9.0\C 8.5\C 9.0<br>Subjects randomized to this sequence received Test lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the first period and then received Control lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the second period. | Device: Test 8.5BC<br>* senofilcon A contact lenses with 8.5 base curve<br>Device: Test 9.0BC<br>* senofilcon A contact lenses with 9.0 base curve<br>Device: Control 8.5BC<br>* narafilcon A contact lenses with 8.5 base curve<br>Device: Control 9.0BC<br>* narafilcon A contact lenses with 9.0 base curve<br>|
| Experimental: T 9.0\T 8.5\C 9.0\C 8.5<br>Subjects randomized to this sequence received Test lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the first period and then received Control lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the second period. | Device: Test 8.5BC<br>* senofilcon A contact lenses with 8.5 base curve<br>Device: Test 9.0BC<br>* senofilcon A contact lenses with 9.0 base curve<br>Device: Control 8.5BC<br>* narafilcon A contact lenses with 8.5 base curve<br>Device: Control 9.0BC<br>* narafilcon A contact lenses with 9.0 base curve<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Fit Acceptance | Overall lens fit acceptance was assessed by the investigator based on lens fitting characteristics and graded on a scale of 0 to 5, where 0=should not be worn and 5=perfect fit. The score ranges from 0 to 5, where higher scores indicate better fitting. The number of eye for each Grade was reported. | 30-45 minutes after lens settling | 
| Lens Power Requirement | The lens power requirements (aka sphere requirements) for each lens type was calculated by summing the lens power and the spherical over-refraction. Then the difference of lens power requirement between the Test and Control lenses was calculated (Test-Control). | 30-45 minutes after lens settling | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Comfort at Lens Insertion | Subjective comfort on insertion was assessed by the subject on an 11-point scale (0 to 10) where 0=painful and 10=can't be felt. The score ranges from 0 to 10, where higher scores indicate better comfort. The average comfort score for each lens was reported. | Immediately upon lens insertion | 
| Subjective Comfort After Lens Settling | Subjective comfort on setting was assessed by the subject on an 11-point scale (0 to 10) where 0=painful and 10=can't be felt. The score ranges from 0 to 10, where higher scores indicate better comfort. The average comfort score for each lens was reported. | 30-45 minutes after lens settling | 
| Subjective Vision Quality | Subjective vision quality was assessed by the subject on an 11-point scale (0 to 10) where 0=extremely blurred and 10=perfect. The score ranges from 0 to 10, where higher scores indicate better vision quality. The average vision quality score for each lens was reported. | 30-45 minutes after lens settling | 
| Subjective Handling | Subjective handling was assessed by the subject on an 11-point scale (0 to 10) where 0=extremely difficult and 10=very easy. The score ranges from 0 to 10, where higher scores indicate better handling. The average handling score for each lens was reported. | Immediately upon lens insertion | 
| Monocular High Contrast Visual Acuity (VA) | Monocular high contrast distance VA with the study lenses was collected to the nearest letter using computer generated logMAR charts. 0.02 logMAR is equivalent to 1 letter. Negative logMAR values indicate better lens performance. The average visual acuity was reported for each lens type. | 30-45 minutes after lens settling |