Assessment of Comfort & Ocular Surface Parameters w Novel Designs of Daily Disposable Silicone Hydrogel Contact Lenses

Study Overview
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Brief Summary
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A comparison of two lens designs manufactured in the same material. The hypothesis is the subjectively rated performance of comfort, vision and lens handling will be better with the modified design compared to the initial design

Detailed Description
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The objectives of the study are to identify possible reasons for the different comfort and vision experience in Japanese CL wearers compared to Caucasian CL wearers and to assess whether the modification of lens thickness in the optical zone results in increased comfort and reduced visual acuity fluctuations in Caucasian eyes.

Official Title
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Assessment of Comfort and Ocular Surface Parameters With Novel Designs of Daily Disposable Silicone Hydrogel Contact Lenses (BASS)

Conditions
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Visual Acuity, Contact Lens Comfort

Intervention / Treatment
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* Device: Menicon Modified Lens Design


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; Is willing and able to follow instructions and maintain the appointment schedule; Is of Caucasian heritage; Habitually wears soft spherical daily disposable contact lenses with a power between -0.50 to -2.75D (inclusive); Demonstrates an acceptable fit with both study CL designs (initial & modified); Is correctable to a visual acuity of 0.20 LogMAR (approximately 20/30) or better (in each eye) with both study CL designs; Has a manifest cylindrical spectacle refraction that does not exceed -1.00DC in either eye; Should own a wearable pair of spectacles. - Exclusion Criteria: Is participating in any concurrent clinical or research study; Has any known active* ocular disease and/or infection; 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 known sensitivity to the diagnostic pharmaceuticals to be used in the study; Is pregnant, lactating or planning a pregnancy at the time of enrolment (by self-report); Is aphakic; Has undergone refractive error 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
Interventional Model Description: This will be a double-masked, cross-over, bilateral wear study design with five (5) study visits across three (3) study visit days. Participants will be dispensed and wear both the initial and modified lens design for a total of six (6) hours each on two (2) separate visit days, with the order of lens wear being randomized; participants will be allowed to leave the CCLR on their lens wearing days between dispense and follow-up visit.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Menicon DSRB Redesign<br>Menicon DSRB Modified Lens Design is a single use contact lens with revised thickness specifications worn for 6 hours or more. | Device: Menicon Modified Lens Design<br>* Randomized in a daily wear, single day (6 hours or more) evaluation<br>|
| Active Comparator: Menicon DSRB Original Design<br>Menicon DSRB Initial Lens Design is a single use contact lens with the original thickness specifications worn for 6 hours or more. | Device: Menicon Modified Lens Design<br>* Randomized in a daily wear, single day (6 hours or more) evaluation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant's subjective rating of comfort, Questionnaire | Participants rate their eye comfort by subjective questionnaire (non-annotated scale, 0-100, 0=painful, 100=can't feel the lenses) | 2 Days | 
| Participant's subjective rating of vision, Questionnaire | Participants rate their vision by subjective questionnaire (non-annotated scale, 0-100, 0=not at all sharp/clear, 100=sharp/clear | 2 Days | 
| Participant's subjective rating of lens handling, Questionnaire | Participants rate their ability to handle the contact lens by subjective questionnaire (non-annotated scale, 0-100, 0=very difficult, 100=very easy | 2 Days |