Clinical Performance Evaluation of Two Silicone Hydrogel Lenses

Study Overview
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Brief Summary
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This is a randomized, double-masked dispensing study where subjects will randomized into one of two lens sequences to wear each of two contact lens types for a 4-week period with each lens type.

Conditions
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Visual Acuity

Intervention / Treatment
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* Device: TEST Contact Lens
* Device: CONTROL Contact Lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. The subject must be between 18 and 40 years of age. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.50 Diopters (D) to -8.00 D in each eye. The subject's refractive cylinder must be no more than -1.00 D cylindrical correction in each eye after vertexing to the corneal plane. The subject must have best corrected visual acuity of 0.20 or better in each eye. The subject must be a current wearer of daily, spherical, soft contact lenses (no bifocal or multifocal contact lenses, no extended wear or monovision) for at least 5 days/week and at least 8 hours/day during the month prior to enrollment. The subject must be using digital devices (any combination of computers, tablets, smart phones etc.) for at least 8 hours over the course of a typical day. The subject should own a wearable pair of spectacles and wear them the day of the baseline visit. The subject must have normal eyes with no evidence of abnormality or disease that in the opinion of the investigator would contraindicate contact lens wear. The subject must meet normal eligibility conditions of binocular vision tests. The subject may not have any double vision at near with their habitual contact lens correction. Exclusion Criteria: Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued). Any ocular or systemic allergies or diseases that may interfere with contact lens wear (at the investigator's discretion). Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear (at the investigator's discretion). Use of any medication that causes side effects similar to side effects experienced when using digital devices, such as a subject reporting headaches associated with birth control pills (at the investigator's discretion). Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease. Any active ocular infection. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.). Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear. Any known hypersensitivity or allergic reaction to the study products. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment. History of binocular vision abnormality or strabismus. Employee of investigational clinic (e.g., Investigator, Coordinator, Technician).

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 (TEST / CONTROL wear sequence)<br>Subjects randomly assigned to the TEST Contact Lens or the CONTROL Contact Lens in the TEST / CONTROL wearing sequence will wear each of the study lenses for 4 weeks according to the manufacturer's guidelines. Subjects will be dispensed the other (second) lens type at the second dispense visit. | Device: TEST Contact Lens<br> <br> * Other names: senofilcon A;Device: CONTROL Contact Lens<br> <br> * Other names: samfilcon A;|
| Active Comparator: Group 2 (CONTROL / TEST wear sequence)<br>Subjects randomly assigned to the TEST Contact Lens or the CONTROL Contact Lens in the CONTROL / TEST wearing sequence will wear each of the study lenses for 4 weeks according to the manufacturer's guidelines. Subjects will be dispensed the other (second) lens type at the second dispense visit. | Device: TEST Contact Lens<br> <br> * Other names: senofilcon A;Device: CONTROL Contact Lens<br> <br> * Other names: samfilcon A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall CLUE Comfort | Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. | Up to 4-Week Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall CLUE Handling | Overall Handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. | Up to 4-Week Follow-up | 
| Time to Haze | Time to haze measure the maximum time a contact lens wearers can keep their eye open without their vision becoming hazy. It was a measure of how the drying of the contact lens surface with open eyes affects vision. | Up to 4-Week Follow-up | 
| Average Wear Time | Average lens wear time with the study lenses were recorded in hour at each follow-up visit. | Up to 4-Week Follow-up | 
| Average Comfortable Wear Time | Average comfortable lens wear time with the study lenses were recorded in hour at each follow-up visit. | Up to 4-Week Follow-up | 
| Difference in Total Device Use Time and Comfortable Wear Time During Device Use | Subjects reported the total duration of their digital device use and comfortable lens wear time during digital device use. | Up to 4-Week Follow-up | 
| Comfort at the End of the Day | Subjects graded the comfort level at the end of the day using 5- point scale (1=excellence, 2=very good, 3=good, 4=fair and 5=poor). The average end of day comfort grade was reported for each lens type. | Up to 4-Week Follow-up |