A 6-Hour Clinical Evaluation of New Daily-Wear Soft Contact Lenses

Study Overview
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Brief Summary
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The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 6 hours compared to nelfilcon A (control).

Detailed Description
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The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 6 hours compared to nelfilcon A (control). The primary outcomes of interest are lens fit and lens fit preference.

Official Title
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A 6-Hour Clinical Evaluation of New Daily-Wear Soft Contact Lenses

Conditions
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Myopia

Intervention / Treatment
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* Device: Test Lens
* Device: Control Lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is at least 18 years of age and has full legal capacity to volunteer Has read, fully understood and signed the information consent letter Currently wears or has previously worn soft contact lenses Has spectacle cylinder ≤1.00D in both eyes. Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes. Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye. Has clear corneas and no active ocular disease Is willing and able to follow product usage instructions and maintain the visit schedule. Exclusion Criteria: Has never worn contact lenses before Has a systemic condition that in the opinion of the investigator may affect a study outcome variable Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable Has any known active ocular disease and/or infection Has a monovision correction Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses Is aphakic Has undergone corneal refractive surgery Is pregnant or lactating, determined by self-report

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This will be a non-dispensing, double-masked, contralateral study comparing test contact lens against a nelfilcon A control lens. Subjects will be randomized to wear the test lens in one eye and the control lens in the other. It is anticipated that this study will involve up to 2 scheduled visits, at Baseline (BL) and 6 hours.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Test lens<br>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule (to determine which eye receives test/control lens). | Device: Test Lens<br>* Daily disposable contact lens<br>Device: Control Lens<br>* Focus Dailies All Day Comfort contact lens (nelfilcon A)<br>|
| Active Comparator: nelfilcon A lens (control)<br>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule (to determine which eye receives test/control lens). | Device: Test Lens<br>* Daily disposable contact lens<br>Device: Control Lens<br>* Focus Dailies All Day Comfort contact lens (nelfilcon A)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Horizontal Lens Centration Assessed in Primary Gaze | Horizontal Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-nasal decentration given +ve value, temporal decentration given -ve value) | Baseline | 
| Horizontal Lens Centration Assessed in Primary Gaze | Horizontal Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-nasal decentration given +ve value, temporal decentration given -ve value) | 6-hour | 
| Vertical Lens Centration Assessed in Primary Gaze | Vertical Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-superior decentration given +ve value, inferior decentration given -ve value) | Baseline | 
| Vertical Lens Centration Assessed in Primary Gaze | Vertical Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-superior decentration given +ve value, inferior decentration given -ve value) | 6-hours | 
| Lens Tightness Assessed by Push-up Test | Lens Tightness was assessed by Push-up test 1% steps: (0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement) | Baseline | 
| Lens Tightness Assessed by Push-up Test | Lens Tightness was assessed by Push-up test 1% steps: (0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement) | 6-hours | 
| Primary Gaze Lag Assessed Observing Lens Movement in Graticule | Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps) | Baseline | 
| Primary Gaze Lag Assessed Observing Lens Movement in Graticule | Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps) | 6 hours | 
| Horizontal Lens Lag Assessed Observing Lens Movement in Graticule | Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps) | Baseline | 
| Horizontal Lens Lag Assessed Observing Lens Movement in Graticule | Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps) | 6 hours | 
| Overall Lens Fit Acceptance | Overall lens fit acceptance based on lens fit alone (scale 0-4 in 0.25 steps: 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum) | Baseline | 
| Overall Lens Fit Acceptance | Overall lens fit acceptance based on lens fit alone (scale 0-4 in 0.25 steps: 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum) | 6 hours | 
| Up Gaze Lag Assessed Observing Lens Movement in Graticule | Up gaze lag was assessed observing lens movement in graticule (0.1mm steps) (The amount of lens drop in mm that occurs when the eye moves from primary gaze to up gaze). | Baseline | 
| Up Gaze Lag Assessed Observing Lens Movement in Graticule | Up gaze lag was assessed observing lens movement in graticule (0.1mm steps) (The amount of lens drop in mm that occurs when the eye moves from primary gaze to up gaze). | 6 hours | 
| Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink | Post-blink Movement was assessed by amount of movement (to the nearest 0.1mm) immediately after the blink | Baseline | 
| Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink | Post-blink Movement was assessed by amount of movement (to the nearest 0.1mm) immediately after the blink | 6 hours |