Influence of Lens Design on Particulate Exchange in the Post-lens Tear Film

Study Overview
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Brief Summary
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This is a 5-visit, controlled, bilateral, randomized, subject-masked, crossover (4 treatments x 4 period), non-dispensing study. Subjects will attend all study visits in their spectacle correction having not worn contact lenses on the day of the visit.

Official Title
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Influence of Lens Design on Particulate Exchange in the Post-lens Tear Film

Conditions
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Visual Acuity

Intervention / Treatment
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* Device: etafilcon a Test 1
* Device: etafilcon A Test 2
* Device: etafilcon A Test 3
* Other: Control


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, 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 (inclusive) years of age at the time of screening. The subject must own a wearable pair of spectacles and be willing to wear them to each study visit. The subject must be an adapted soft contact lens wearer in both eyes, having successfully worn contact lenses in the last six months by self-report. The subject must agree not to participate in other clinical research for the duration of this study. The subject's refractive cylinder must be <-1.25DC in each eye. The subject must have best corrected visual acuity of 0.20 logMAR or better in each eye. Exclusion Criteria: Potential subjects who meet any of the following criteria will be excluded from participating in the study: Currently pregnant or breast feeding (self-reported). Any systemic disease (e.g., Sjögren's Syndrome), 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 (at the Investigator's discretion). Use of topical medication such as eye drops or ointment within 24 hours prior to the study visit. Any history of anaphylaxis or severe allergy. Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.) Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician) They have any slit lamp findings of grade 3 or higher (e.g. corneal edema, corneal neovascularization, tarsal abnormalities, conjunctival injection) or findings of < Grade 3 which in the investigator's opinion would contraindicate contact lens wear.

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 |
| --- | --- |
| Experimental: Test1/Test2/Control/Test3<br>Subjects that are adapted soft contact lens wearers between the ages of 18-40 years of age will be randomly assigned to one of four sequences. Upon completion, each subject will have worn all three lens types and been assigned the bare eye condition in both eyes. | Device: etafilcon a Test 1<br>* 1-DAY ACUVUE® MOIST<br>Device: etafilcon A Test 2<br>* 1-DAY ACUVUE® MOIST for ASTIGMATISM<br>Device: etafilcon A Test 3<br>* 1-DAY ACUVUE® MOIST MULTIFOCAL<br>Other: Control<br>* Bare Eye<br>|
| Experimental: Test2/Test3/Test1/Control<br>Subjects that are adapted soft contact lens wearers between the ages of 18-40 years of age will be randomly assigned to one of four sequences. Upon completion, each subject will have worn all three lens types and been assigned the bare eye condition in both eyes. | Device: etafilcon a Test 1<br>* 1-DAY ACUVUE® MOIST<br>Device: etafilcon A Test 2<br>* 1-DAY ACUVUE® MOIST for ASTIGMATISM<br>Device: etafilcon A Test 3<br>* 1-DAY ACUVUE® MOIST MULTIFOCAL<br>Other: Control<br>* Bare Eye<br>|
| Experimental: Test3/Control/Test2/Test1<br>Subjects that are adapted soft contact lens wearers between the ages of 18-40 years of age will be randomly assigned to one of four sequences. Upon completion, each subject will have worn all three lens types and been assigned the bare eye condition in both eyes. | Device: etafilcon a Test 1<br>* 1-DAY ACUVUE® MOIST<br>Device: etafilcon A Test 2<br>* 1-DAY ACUVUE® MOIST for ASTIGMATISM<br>Device: etafilcon A Test 3<br>* 1-DAY ACUVUE® MOIST MULTIFOCAL<br>Other: Control<br>* Bare Eye<br>|
| Experimental: Control/Test1/Test3/Test2<br>Subjects that are adapted soft contact lens wearers between the ages of 18-40 years of age will be randomly assigned to one of four sequences. Upon completion, each subject will have worn all three lens types and been assigned the bare eye condition in both eyes. | Device: etafilcon a Test 1<br>* 1-DAY ACUVUE® MOIST<br>Device: etafilcon A Test 2<br>* 1-DAY ACUVUE® MOIST for ASTIGMATISM<br>Device: etafilcon A Test 3<br>* 1-DAY ACUVUE® MOIST MULTIFOCAL<br>Other: Control<br>* Bare Eye<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microsphere Clearance Rate | The rate of microsphere clearance from the post-lens tear film was assessed by the C30 image analysis metric. Where bare eye was assigned, a droplet of microsphere suspension was applied directly onto the superior temporal conjunctiva. Where lens wear was assigned, the microsphere suspension was dispensed onto the posterior concave contact lens surface immediately prior to lens application. A series of digital images were taken over a 30-minute period (every minute for the first 10 minutes and then every 5 minutes for the next 20 minutes). Data transformed from the images were calculated by the C30 image analysis metric. Higher numbers represented greater clearance. The right eye was used to evaluate microsphere clearance. | Post microsphere application over a 30 minute period | 
| Microsphere Uptake Rate | The rate of microsphere uptake into the post-lens tear film was assessed by the U5 image analysis metric. Where bare eye was assigned, a droplet of microsphere suspension was applied directly onto the superior temporal conjunctiva. Where a lens was assigned the lens was applied and after a 10-minute settling period, a droplet of microsphere suspension was applied directly to the superior temporal conjunctiva. A series of digital images were taken over a 10-minute period (every minute for 10 minutes). Data transformed from the images were calculated by the U5 image analysis metric. Higher numbers represented greater uptake rate. The left eye was used to evaluate microsphere uptake. | Post microsphere application over a 10 minute period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Movement | Lens movement was assessed for primary gaze, up-gaze, and push up by clinical grading. Primary gaze movement was evaluated by observing the vertical movement of the contact lens that occurs with a full blink without manipulating the subject's lids. Up-gaze movement was assessed by estimating the vertical lens movement observed when the subject looks up and blinks fully without manipulating the subject's lids. The push-up test consists of a gentle digital push of the lens upwards using the lower lid. The resistance of the lens to of the lens to upward movement is judged. Lens movement was graded according to the following scale: Excessive (+2), Moderate movement (+1), Optimal (0), Minimal (-1), and Insufficient (-2). All available data for lens movement in the safety population were reported. | Post microsphere application at 30-minute timepoint (OD); post microsphere application at 10-minute timepoint (OS) | 
| Corneal Curvature | Corneal curvature was assessed by Visante™ OCT. The following were measured: Sclera Angle-Temporal and Sclera Angle-Nasal. | Baseline | 
| Corneal Curvature | Corneal curvature was assessed by Visante™ OCT. Sagital Height was measured. | Baseline | 
| Blink Rate | Blinking characteristics were captured using an infra-red camera (FLIR Grasshopper 3 camera) and infra-red LED illumination (Thorlabs LIU780A). During video capture the subject was directed to view a wildlife video on an Ipad at a working distance of approximately 1 meter. The infrared video was captured for 3 minutes at 500 frames per second. Subsequent video analysis recorded the blink rate (blinks per minute) over the 3-minute period. Baseline values were reported across all subjects who were dispensed a study lens. Blink rate post microsphere application was reported by treatment. All available data for blink rate in the safety population were reported. | Baseline and the 30-minute post microsphere application time point in the right eye and at the 10-minute post microsphere application timepoint in the left eye. |