A Clinical Trial to Evaluate Investigational Silicone Hydrogel Contact Lenses Worn Continuously for One Week

Study Overview
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Brief Summary
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This study is a prospective, randomized, double-masked, bilateral, dispensing, parallel-group clinical trial design. All subjects will participate in a 2-week daily disposable contact lens adaptation period prior to being randomized into one of the four extended wear lenses. The study has a total of 9 scheduled study visits and a total duration of  197 days. The lenses will be replaced with a fresh pair after 6 nights / 7 days of wear.

Official Title
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Echo Ionic Silicone Hydrogel 6-Month Extended Wear Investigation

Conditions
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Visual Disorder

Intervention / Treatment
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* Device: Investigational Lens 1
* Device: Investigational Lens 2
* Device: Investigational Lens 3
* Device: etafilcon A (Reusable)
* Device: etafilcon A (1-Day)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject must read and understand English 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 at least 18 and no more than 39 years of age. The subject's spherical equivalent distance refraction must be in the range of -1.00 to -5.50 diopters in each eye. The subject's refractive cylinder must be less than 1.00 diopters in each eye. The subject must have best corrected visual acuity of 20/30 or better in each eye. The subject must be without history of contact lens use in the past 12 months. The subject must have normal eyes (i.e., no ocular medications or infections of any type). Exclusion Criteria: Any previous experience wearing contact lenses on an overnight or extended wear basis (at least 1 night per month) Currently pregnant or lactating (self reported) (subjects who become pregnant during the study will be discontinued). Currently a regular smoker (1 or more times per month). Current routine swimmer (1 or more times per month). Any ocular or systemic allergies or diseases that may interfere with contact lens wear. Any systemic disease (ex. Sjögren's Syndrome), autoimmune disease (ex. rheumatoid arthritis), or use of medication (ex. chronic steroid use), which may interfere with contact lens wear. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry. Any previous or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser in situ keratomileusis (LASIK), etc.). Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear. Any ocular infection. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. 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. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV) by self report). Employee of investigational clinic (e.g., Investigator, Coordinator, Technician).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: etafilcon A (1-Day) and etafilcon A (Reusable)<br>Prior to randomization, all subjects will participate in a 2-week contact lens adaptation period wearing etafilcon A (1-Day). Subjects will then be randomized to one of four experimental contact lenses to be worn continuously in 6 nights/7 days wear cycles for 6 months of total wear. | Device: etafilcon A (Reusable)<br>* One fresh pair of etafilcon A (Reusable) contact lenses worn continuously in 6nights/7 days wear cycles for 6 months of total wear.<br>Device: etafilcon A (1-Day)<br>* 2-week contact lens adaptation period wearing prior to randomization<br>|
| Experimental: etafilcon A (1-Day) and Investigational Lens 1<br>Prior to randomization, all subjects will participate in a 2-week contact lens adaptation period wearing etafilcon A (1-Day). Subjects will then be randomized to one of four experimental contact lenses to be worn continuously in 6 nights/7 days wear cycles for 6 months of total wear. | Device: Investigational Lens 1<br>* One fresh pair of Investigational Lens 1 contact lenses worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.<br>Device: etafilcon A (1-Day)<br>* 2-week contact lens adaptation period wearing prior to randomization<br>|
| Experimental: etafilcon A (1-Day) and Investigational Lens 2<br>Prior to randomization, all subjects will participate in a 2-week contact lens adaptation period wearing etafilcon A (1-Day). Subjects will then be randomized to one of four experimental contact lenses to be worn continuously in 6 nights/7 days wear cycles for 6 months of total wear. | Device: Investigational Lens 2<br>* One fresh pair of Investigational Lens 2 contact lenses worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.<br>Device: etafilcon A (1-Day)<br>* 2-week contact lens adaptation period wearing prior to randomization<br>|
| Experimental: etafilcon A (1-Day) and Investigational Lens 3<br>Prior to randomization, all subjects will participate in a 2-week contact lens adaptation period wearing etafilcon A (1-Day). Subjects will then be randomized to one of four experimental contact lenses to be worn continuously in 6 nights/7 days wear cycles for 6 months of total wear. | Device: Investigational Lens 3<br>* One fresh pair of Investigational Lens 3 contact lenses worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.<br>Device: etafilcon A (1-Day)<br>* 2-week contact lens adaptation period wearing prior to randomization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of First Occurred Serious and Significant Lens-related Corneal Infiltrative Event (CIE) | The number of first serious and significant corneal infiltrative adverse events deemed to be related to contact lens wear (possible, probable or very likely) during a 6-month period (contact lens extended wear period) was assessed via Biomicroscopy. A biomicroscope was used to detect the presence of a corneal infiltrate for each subject eye (Yes: corneal infiltrates detected, No: None present). The number of subjects with corneal infiltrative events was reported for each lens type. | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Comfort Score | Overall comfort was assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD). CLUE was collected at the 1-day, 5-day, 12-day, 26-day, 88-day and 180-day follow-up evaluation. | Time Frame Up to 6 months | 
| Overall Vision Score | Overall quality of vision score was assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD). CLUE was collected at the 1-day, 5-day, 12-day, 26-day, 88-day and 180-day follow-up evaluation. | Time Frame Up to 6 months |