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Comparative Study to Evaluate the Cosmetic Appearance of Two Brands (Coopervision (CVI) vs. Competitor)of Color Soft Contact Lenses
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - Verde (Competitor-control) vs. Green (CVI-test) | Other | Each subject was randomized to wear the test and control lenses contralaterally. |
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| Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test) | Other | Each subject was randomized to wear the test and control lenses contralaterally. |
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| Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test) | Other | Each subject was randomized to wear the test and control lenses contralaterally. |
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| Group 4 - Azul (Competitor-control) vs. Blue (CVI-test) | Other | Each subject was randomized to wear the test and control lenses contralaterally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verde (Competitor-control) | Device | contact lens |
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| 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 |
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Inclusion Criteria:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Ruben Velazquez Guerrero, MSc FIACLE | School of Optometry, National Autonomous University (UNAM), Mexico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Optometry Clinic, National Autonomous University | Mexico City | Mexico |
One participant was disqualified from the study due to not meeting inclusion criteria before lens dispensing.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 - Verde (Competitor-control) vs. Green (CVI-test) | Each subject was randomized to wear the test and control lenses contralaterally. |
| FG001 | Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Green (CVI-test) | Device | contact lens |
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| Cinza (Competitor-control) | Device | contact lens |
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| Grey (CVI-test) | Device | contact lens |
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| Esmeralda (Competitor-control) | Device | contact lens |
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| Jade (CVI-test) | Device | contact lens |
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| Azul (Competitor-control) | Device | contact lens |
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| Blue (CVI-test) | Device | contact lens |
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Each subject was randomized to wear the test and control lenses contralaterally.
| FG002 | Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test) | Each subject was randomized to wear the test and control lenses contralaterally. |
| FG003 | Group 4 - Azul (Competitor-control) vs. Blue (CVI-test) | Each subject was randomized to wear the test and control lenses contralaterally. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 - Verde (Competitor-control) vs. Green (CVI-test) | Each subject was randomized to wear the test and control lenses contralaterally. |
| BG001 | Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test) | Each subject was randomized to wear the test and control lenses contralaterally. |
| BG002 | Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test) | Each subject was randomized to wear the test and control lenses contralaterally. |
| BG003 | Group 4 - Azul (Competitor-control) vs. Blue (CVI-test) | Each subject was randomized to wear the test and control lenses contralaterally. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | participants | 20 minutes |
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| Primary | Comfort | Participant's subjective rating for comfort. (Scale 0-10, 0=poor, 10=excellent). | Posted | Mean | Standard Deviation | units on a scale | Baseline |
| |||||||||||||||||||||||||||||||||||||
| Primary | Comfort | Participant's subjective rating for comfort. (Scale 0-10, 0=poor, 10=excellent). | Posted | Mean | Standard Deviation | units on a scale | 20 minutes |
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| Primary | 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 | Posted | Number | participants | Baseline |
| ||||||||||||||||||||||||||||||||||||||
| Primary | 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 | Posted | Number | participants | 20 minutes |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Overall Participants | Each subject was randomized to wear the test and control lenses in a series of four short fitting comparisons (pair 1, pair 2, pair 3, and pair 4). | 0 | 40 | 0 | 40 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Manager Global Medical Scientific Affairs | CooperVision | (925) 621-3761 | javega@coopervision.com |
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Male |
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| CVI-test lens |
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| No preference |
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