Comparative Study to Evaluate the Cosmetic Appearance of Two Brands (Coopervision (CVI) vs. Competitor) of Color Soft Contact Lenses.

Study Overview
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Brief Summary
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Comparative Study to Evaluate the Cosmetic Appearance of Two Brands (Coopervision (CVI) vs. Competitor)of Color Soft Contact Lenses

Detailed Description
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Each lens pair comparison will require two visits over two days, as follows: Visits: V1 (lens dispensing), V2 (20 minutes post lens settling). Each subject will be randomized to wear the test and control lenses in a series of four short fitting comparisons.

Official Title
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Comparative Study to Evaluate the Cosmetic Appearance of Two Brands (Coopervision (CVI) vs. Competitor) of Color Soft Contact Lenses.

Conditions
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Myopia

Intervention / Treatment
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* Device: Verde (Competitor-control)
* Device: Green (CVI-test)
* Device: Cinza (Competitor-control)
* Device: Grey (CVI-test)
* Device: Esmeralda (Competitor-control)
* Device: Jade (CVI-test)
* Device: Azul (Competitor-control)
* Device: Blue (CVI-test)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is between 18 and 40 years of age (inclusive). Has had a self-reported visual exam in the last two years. Is an adapted wearer of spherical soft contact lenses. Has a contact lens spherical prescription between - 1.00 and - 10.00 (inclusive). Has a spectacle cylinder up to 0.75 diopter (D) in each eye Can achieve best corrected spectacle distance visual acuity of 20/30 (0.18 logMAR) or better in each eye. Has clear corneas and no active ocular disease. Has read, understood and signed the information consent letter. Is willing to wear his/hers spectacles over the study contact lenses. Is willing to comply with the wear schedule. Is willing to comply with the visit schedule. Exclusion Criteria: Has never worn contact lenses before. Currently wears rigid gas permeable contact lenses. Has a history of not achieving comfortable contact lens wear (5 days per week; > 8 hours/day) Has a contact lens prescription outside the range of - 1.00 to -10.00D. Has a spectacle cylinder ≥1.00D of cylinder in either eye. Does not have a pair of corrective spectacles at the time of the visit. Cannot achieve best corrected spectacle distance visual acuity of 20/30 (0.18 logMAR) or better in each eye. Presence of clinically significant (grade > 2.0, scale 0-4) anterior segment abnormalities. Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear. Slit lamp findings that would contraindicate contact lens wear such as: Pathological dry eye or associated findings Pterygium, pinguecula, or corneal scars within the visual axis Neovascularization > 0.75 mm in from of the limbus Giant papillary conjunctivitis (GCP) worse than grade 1 Anterior uveitis or iritis (past or present) Seborrheic eczema, Seborrheic conjunctivitis History of corneal ulcers or fungal infections Poor personal hygiene Has a known history of corneal hypoesthesia (reduced corneal sensitivity) Has aphakia, keratoconus or a highly irregular cornea. Has Presbyopia or has dependence on spectacles for near work over the contact lenses. Has undergone corneal refractive surgery. Is participating in any other type of eye related clinical or research study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1 - Verde (Competitor-control) vs. Green (CVI-test)<br>Each subject was randomized to wear the test and control lenses contralaterally. | Device: Verde (Competitor-control)<br>* contact lens<br>* Other names: methafilcon A;Device: Green (CVI-test)<br>* contact lens<br>* Other names: methafilcon A;|
| Other: Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)<br>Each subject was randomized to wear the test and control lenses contralaterally. | Device: Cinza (Competitor-control)<br>* contact lens<br>* Other names: methafilcon A;Device: Grey (CVI-test)<br>* contact lens<br>* Other names: methafilcon A;|
| Other: Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)<br>Each subject was randomized to wear the test and control lenses contralaterally. | Device: Esmeralda (Competitor-control)<br>* contact lens<br>* Other names: methafilcon A;Device: Jade (CVI-test)<br>* contact lens<br>* Other names: methafilcon A;|
| Other: Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)<br>Each subject was randomized to wear the test and control lenses contralaterally. | Device: Azul (Competitor-control)<br>* contact lens<br>* Other names: methafilcon A;Device: Blue (CVI-test)<br>* contact lens<br>* Other names: methafilcon A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cosmetic Appearance Preference | Participant's subjective preference for cosmetic appearance. 3 point Likert Scale. 1=prefer CVI-test lens 2=prefer Competitor-control lens, 3=no preference | 20 minutes | 
| Comfort | Participant's subjective rating for comfort. (Scale 0-10, 0=poor, 10=excellent). | Baseline | 
| Comfort | Participant's subjective rating for comfort. (Scale 0-10, 0=poor, 10=excellent). | 20 minutes | 
| Comfort Preference | Participant's subjective preference for comfort on a 3 point Likert Scale. 1=prefer CVI-test lens, 2=prefer Competitor-control lens, 3=no preference | Baseline | 
| Comfort Preference | Participant's subjective preference for comfort on a 3 point Likert Scale. 1=prefer CVI-test lens, 2=prefer Competitor-control lens, 3=no preference | 20 minutes |