To Evaluate The Performance Of Two Monthly Replacement Silicone Hydrogel Contact Lenses After 1-month Of Wear

Study Overview
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Brief Summary
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To evaluate the performance of two monthly replacement silicone hydrogel contact lenses in habitual FRP CL wearers when worn for 1-month.

Detailed Description
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This study will be a prospective, randomized, double-masked, single-site, 1-month cross-over design involving bilateral eye daily wear of two different monthly replacement CL types. Each lens will be worn bilaterally for approximately one month.

Official Title
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To Evaluate The Performance Of Two Monthly Replacement Silicone Hydrogel Contact Lenses After 1-month Of Wear

Conditions
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Myopia

Intervention / Treatment
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* Device: Lens A (lehfilcon A lens)
* Device: Lens B (comfilcon A lens)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is at least 17 years of age and has full legal capacity to volunteer; Self-reports having had a full eye examination within the previous 2 years; Has read and signed an information consent letter; Is willing and able to follow instructions and maintain the appointment schedule; Is a habitual wearer of frequent replacement contact lenses; Anticipates no difficulty wearing the contact lenses for 6 days/week and 8 hours/day during the study; Has refractive astigmatism no higher than -0.75DC in each eye; Can be successfully fit with both study lens types; Achieves at least 0.4 logMAR VA monocularly and at least 0.2 logMAR VA binocularly with each study lens type. Exclusion Criteria: Is participating in any concurrent clinical research study; Has any known active ocular disease and/or infection; Has an unstable systemic condition that in the opinion of the investigator may affect vision or contact lens comfort across the 2-month study duration; Is using any systemic or topical medications in an irregular routine that in the opinion of the investigator may affect vision or contact lens comfort across the 2-month study duration; Has known sensitivity to the diagnostic sodium fluorescein to be used in the study; Is an employee of the Centre for Ocular Research & Education.

Ages Eligible for Study
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Minimum Age: 17 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, Then Lens B<br>Participants wore Lens A for one month and then crossed over to wear Lens B for one month. | Device: Lens A (lehfilcon A lens)<br>* Daily wear for 1 month.<br>Device: Lens B (comfilcon A lens)<br>* Daily wear for 1 month.<br>|
| Experimental: Lens B, Then Lens A<br>Participants wore Lens B for one month and then crossed over to wear Lens A for one month. | Device: Lens A (lehfilcon A lens)<br>* Daily wear for 1 month.<br>Device: Lens B (comfilcon A lens)<br>* Daily wear for 1 month.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Handling on Lens Removal | Lens handling on removal will be measured on a scale of 0-10, 0.5 steps (0=Completely dissatisfied,10=Completely satisfied) | 1 month |