Comparison of Lens Fit and Lens Power of a New Contact Lens to Two Marketed Contact Lenses in a Population of Soft Contact Lens Wearers

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the comparability of lens fit and lens power of a new contact lens to the lens fit and lens power of two marketed lenses.

Conditions
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Myopia

Intervention / Treatment
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* Device: galy A Plus
* Device: seno A
* Device: galy A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be at least 18 years of age and no more than 55 years of age. Must sign written informed consent. Optimal spherical equivalent distance correction must be between -1.00 and -6.00 diopters. Have spectacle astigmatism ≤ -0.75 diopter cylinder in both eyes. Must have visual acuity best correctable to 20/25+3 or better for each eye. Must appear able and willing to adhere to the instructions set forth in this clinical protocol. Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: No evidence of lid abnormality or infection; No conjunctival abnormality or infection; No clinical significant slit lamp findings, (i.e., oedema, staining, scarring, vascularization, infiltrates or abnormal opacities); No other active ocular disease. The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of daily wear for a minimum of 1 month prior to the study) and willing to wear the study lenses on a daily wear basis (defined as a minimum of 6 hours of wear per day at least five days of the week) for the duration of the study. Exclusion Criteria: Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear. Any previous eye surgery involving the anterior segment. Pre-existing ocular disease that would preclude contact lens fitting. Abnormal lacrimal secretions. Keratoconus or other corneal irregularity. Pregnancy, lactating or planning a pregnancy at the time of enrollment. Participation in any concurrent clinical trial. Subject's habitual contact lens type is toric or multifocal. Require any concurrent ocular medication.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: galy A Plus/ galy A / seno A<br>Pair 1: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 2: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 3: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8). | Device: galy A Plus<br>* galyfilcon A Plus, BC: 8.3 or 8.7<br>Device: seno A<br>* senofilcon A, BC:8.4 or 8.8<br>Device: galy A<br>* galyfilcon A , BC: 8.3 or 8.7<br>|
| Other: galy A Plus / seno A / galy A<br>Pair 1: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 2: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8). Pair 3: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). | Device: galy A Plus<br>* galyfilcon A Plus, BC: 8.3 or 8.7<br>Device: seno A<br>* senofilcon A, BC:8.4 or 8.8<br>Device: galy A<br>* galyfilcon A , BC: 8.3 or 8.7<br>|
| Other: galy A / galy A Plus / seno A<br>Pair 1: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 2: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 3: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8). | Device: galy A Plus<br>* galyfilcon A Plus, BC: 8.3 or 8.7<br>Device: seno A<br>* senofilcon A, BC:8.4 or 8.8<br>Device: galy A<br>* galyfilcon A , BC: 8.3 or 8.7<br>|
| Other: galy A / seno A / galy A Plus<br>Pair 1: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 2: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8). Pair 3: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). | Device: galy A Plus<br>* galyfilcon A Plus, BC: 8.3 or 8.7<br>Device: seno A<br>* senofilcon A, BC:8.4 or 8.8<br>Device: galy A<br>* galyfilcon A , BC: 8.3 or 8.7<br>|
| Other: seno A / galy A / glay A Plus<br>Pair 1: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8). Pair 2: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 3: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). | Device: galy A Plus<br>* galyfilcon A Plus, BC: 8.3 or 8.7<br>Device: seno A<br>* senofilcon A, BC:8.4 or 8.8<br>Device: galy A<br>* galyfilcon A , BC: 8.3 or 8.7<br>|
| Other: seno A / galy A Plus / galy A<br>Pair 1: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8). Pair 2: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 3: galy A -subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). | Device: galy A Plus<br>* galyfilcon A Plus, BC: 8.3 or 8.7<br>Device: seno A<br>* senofilcon A, BC:8.4 or 8.8<br>Device: galy A<br>* galyfilcon A , BC: 8.3 or 8.7<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Centration Acceptance | Investigator evaluated as acceptable (centered/slightly decentered) or unacceptable (substantially decentered). Number of eyes in each category will be reported by lens. This is an aggregate reporting of the lenses, combining the different base curves into a category by lens type. This is done per protocol, due to this primary outcome not being stratified by base curve. | after 15 minutes of contact lens wear | 
| Primary Gaze Lens Movement | Investigator evaluated as acceptable (minimal or moderate movement) or unacceptable (insufficient or excessive movement). Percent of eyes in each category will be evaluated. | after 15 minutes of contact lens wear | 
| Fit Acceptability | Investigator evaluated lens fit using a six point scale: 5-optimal...3-borderline acceptable...2-unacceptable. Percent of eyes in each category will be evaluated. | after 15 minutes of contact lens wear | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New Lens Power Fit Match to Control Lenses | The lens power fit of test lenses will be compared to control lenses to determine if the power matches. Percent of eyes with exact power fit will be evaluated. | after 15 minutes of contact lens wear |