Performance Evaluation of Two Daily Disposable Toric Lens Designs in Habitual Soft Contact Lens Wearers

Study Overview
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Brief Summary
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The objective of the study is to compare the clinical performance of two different daily disposable, SiHy toric contact lens types, Lens A and Lens B, in existing soft lens wearers when worn for one week each.

Detailed Description
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This study is a prospective, bilateral eye, double-masked, randomized, 1-week cross-over, daily-wear design involving two different daily disposable toric lens types. Each lens type will be worn for approximately one week, during which participants record their subjective lens-wear experience.

Official Title
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Performance Evaluation of Two Daily Disposable Toric Lens Designs in Habitual Soft Contact Lens Wearers

Conditions
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Astigmatism

Intervention / Treatment
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* Device: Lens A
* Device: Lens B


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 and signed an information consent letter; Self reports having a full eye examination in the previous two years; Anticipates being able to wear the study lenses for at least 12 hours a day, 7 days a week; Is willing and able to follow instructions and maintain the appointment schedule; Habitually wears toric soft contact lenses binocularly, of any replacement frequency, for the past 3 months minimum; Has refractive astigmatism at least -0.75DC in each eye, maximum -2.25DC; Has refractive cylinder axis either between 155 to 25 or between 65 and 115 degrees; Is myopic and requires a spectacle spherical component of -1.00D to -6.50D inclusively; Can be fit and achieve binocular distance vision of at least 20/30 Snellen with the available lens parameters Exclusion Criteria: Is participating in any concurrent clinical or research study; Habitually wears one of the study contact lenses; Has any known active ocular disease and/or infection that contraindicates contact lens wear; 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 contact lens wear or a study outcome variable; Has known sensitivity to the diagnostic sodium fluorescein used in the study; Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment; Has undergone refractive error surgery or intraocular surgery.

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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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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lens A<br>daily disposable soft contact lens - test lens Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week. | Device: Lens A<br>* daily disposable soft contact lens - test lens<br>Device: Lens B<br>* daily disposable soft contact lens - control lens<br>|
| Active Comparator: Lens B<br>daily disposable soft contact lens - control lens Subjects will be randomized to wear control lenses for one week and then cross-over to test lenses for one week. | Device: Lens A<br>* daily disposable soft contact lens - test lens<br>Device: Lens B<br>* daily disposable soft contact lens - control lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Ease of Lens Handling | Ease of overall lens handling for putting on eyes, removing from eyes, and opening packaging will be measured on a 0-10 integer scale (0=Very difficult, 10-Very easy) | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | Visual acuity will be measured using LogMAR scale in high room illumination high contrast: distance (≥4m) | Baseline - after lenses have settled for 10 minutes | 
| Visual Acuity | Visual acuity will be measured using LogMAR scale in high room illumination high contrast: distance (≥4m) | 1 week |