Myopia
Conditions
Brief summary
Comparative Study to Evaluate the Cosmetic Appearance of Two Brands (Coopervision (CVI) vs. Competitor)of Color Soft Contact Lenses
Detailed description
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.
Interventions
DEVICEVerde (Competitor-control)
contact lens
DEVICEGreen (CVI-test)
contact lens
DEVICECinza (Competitor-control)
contact lens
DEVICEGrey (CVI-test)
contact lens
DEVICEEsmeralda (Competitor-control)
contact lens
DEVICEJade (CVI-test)
contact lens
DEVICEAzul (Competitor-control)
contact lens
DEVICEBlue (CVI-test)
contact lens
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cosmetic Appearance Preference | 20 minutes | Participant's subjective preference for cosmetic appearance. 3 point Likert Scale. 1=prefer CVI-test lens 2=prefer Competitor-control lens, 3=no preference |
| Comfort | Baseline | Participant's subjective rating for comfort. (Scale 0-10, 0=poor, 10=excellent). |
| Comfort Preference | Baseline | 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 |
Countries
Mexico
Participant flow
Pre-assignment details
One participant was disqualified from the study due to not meeting inclusion criteria before lens dispensing.
Participants by arm
| Arm | Count |
|---|---|
| Group 1 - Verde (Competitor-control) vs. Green (CVI-test) Each subject was randomized to wear the test and control lenses contralaterally. | 10 |
| Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test) Each subject was randomized to wear the test and control lenses contralaterally. | 10 |
| Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test) Each subject was randomized to wear the test and control lenses contralaterally. | 10 |
| Group 4 - Azul (Competitor-control) vs. Blue (CVI-test) Each subject was randomized to wear the test and control lenses contralaterally. | 10 |
| Total | 40 |
Baseline characteristics
| Characteristic | Group 1 - Verde (Competitor-control) vs. Green (CVI-test) | Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test) | Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test) | Group 4 - Azul (Competitor-control) vs. Blue (CVI-test) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 21.5 years STANDARD_DEVIATION 2.3 | 21.8 years STANDARD_DEVIATION 2.3 | 20.7 years STANDARD_DEVIATION 2.4 | 20.9 years STANDARD_DEVIATION 1.9 | 21.2 years STANDARD_DEVIATION 2.1 |
| Sex: Female, Male Female | 9 Participants | 5 Participants | 10 Participants | 9 Participants | 33 Participants |
| Sex: Female, Male Male | 1 Participants | 5 Participants | 0 Participants | 1 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
Comfort
Participant's subjective rating for comfort. (Scale 0-10, 0=poor, 10=excellent).
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 - Verde (Competitor-control) vs. Green (CVI-test) | Comfort | Competitor-control lens | 8.6 units on a scale | Standard Deviation 2.2 |
| Group 1 - Verde (Competitor-control) vs. Green (CVI-test) | Comfort | CVI-test lens | 7.3 units on a scale | Standard Deviation 1.7 |
| Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test) | Comfort | CVI-test lens | 8.2 units on a scale | Standard Deviation 1.9 |
| Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test) | Comfort | Competitor-control lens | 7.1 units on a scale | Standard Deviation 2.3 |
| Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test) | Comfort | Competitor-control lens | 8.2 units on a scale | Standard Deviation 1.7 |
| Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test) | Comfort | CVI-test lens | 7.0 units on a scale | Standard Deviation 2.9 |
| Group 4 - Azul (Competitor-control) vs. Blue (CVI-test) | Comfort | Competitor-control lens | 7.1 units on a scale | Standard Deviation 2.2 |
| Group 4 - Azul (Competitor-control) vs. Blue (CVI-test) | Comfort | CVI-test lens | 8.0 units on a scale | Standard Deviation 2.1 |
Primary
Comfort
Participant's subjective rating for comfort. (Scale 0-10, 0=poor, 10=excellent).
Time frame: 20 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 - Verde (Competitor-control) vs. Green (CVI-test) | Comfort | Competitor control lens | 9.3 units on a scale | Standard Deviation 0.8 |
| Group 1 - Verde (Competitor-control) vs. Green (CVI-test) | Comfort | CVI-test lens | 7.5 units on a scale | Standard Deviation 1.7 |
| Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test) | Comfort | CVI-test lens | 8.0 units on a scale | Standard Deviation 1.9 |
| Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test) | Comfort | Competitor control lens | 8.3 units on a scale | Standard Deviation 1.2 |
| Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test) | Comfort | Competitor control lens | 8.6 units on a scale | Standard Deviation 1 |
| Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test) | Comfort | CVI-test lens | 7.3 units on a scale | Standard Deviation 2 |
| Group 4 - Azul (Competitor-control) vs. Blue (CVI-test) | Comfort | Competitor control lens | 8.1 units on a scale | Standard Deviation 1.8 |
| Group 4 - Azul (Competitor-control) vs. Blue (CVI-test) | Comfort | CVI-test lens | 8.8 units on a scale | Standard Deviation 1.4 |
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
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 - Verde (Competitor-control) vs. Green (CVI-test) | Comfort Preference | Competitor-control lens | 9 participants |
| Group 1 - Verde (Competitor-control) vs. Green (CVI-test) | Comfort Preference | No preference | 0 participants |
| Group 1 - Verde (Competitor-control) vs. Green (CVI-test) | Comfort Preference | CVI-test lens | 1 participants |
| Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test) | Comfort Preference | Competitor-control lens | 4 participants |
| Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test) | Comfort Preference | No preference | 2 participants |
| Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test) | Comfort Preference | CVI-test lens | 4 participants |
| Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test) | Comfort Preference | CVI-test lens | 5 participants |
| Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test) | Comfort Preference | Competitor-control lens | 3 participants |
| Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test) | Comfort Preference | No preference | 2 participants |
| Group 4 - Azul (Competitor-control) vs. Blue (CVI-test) | Comfort Preference | Competitor-control lens | 3 participants |
| Group 4 - Azul (Competitor-control) vs. Blue (CVI-test) | Comfort Preference | No preference | 1 participants |
| Group 4 - Azul (Competitor-control) vs. Blue (CVI-test) | Comfort Preference | CVI-test lens | 6 participants |
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
Time frame: 20 minutes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 - Verde (Competitor-control) vs. Green (CVI-test) | Comfort Preference | Competitor-control lens | 8 participants |
| Group 1 - Verde (Competitor-control) vs. Green (CVI-test) | Comfort Preference | No preference | 0 participants |
| Group 1 - Verde (Competitor-control) vs. Green (CVI-test) | Comfort Preference | CVI-test lens | 2 participants |
| Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test) | Comfort Preference | Competitor-control lens | 4 participants |
| Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test) | Comfort Preference | No preference | 0 participants |
| Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test) | Comfort Preference | CVI-test lens | 6 participants |
| Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test) | Comfort Preference | CVI-test lens | 5 participants |
| Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test) | Comfort Preference | Competitor-control lens | 4 participants |
| Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test) | Comfort Preference | No preference | 1 participants |
| Group 4 - Azul (Competitor-control) vs. Blue (CVI-test) | Comfort Preference | Competitor-control lens | 4 participants |
| Group 4 - Azul (Competitor-control) vs. Blue (CVI-test) | Comfort Preference | No preference | 2 participants |
| Group 4 - Azul (Competitor-control) vs. Blue (CVI-test) | Comfort Preference | CVI-test lens | 4 participants |
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
Time frame: 20 minutes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 - Verde (Competitor-control) vs. Green (CVI-test) | Cosmetic Appearance Preference | Competitor-control lens | 8 participants |
| Group 1 - Verde (Competitor-control) vs. Green (CVI-test) | Cosmetic Appearance Preference | No preference | 0 participants |
| Group 1 - Verde (Competitor-control) vs. Green (CVI-test) | Cosmetic Appearance Preference | CVI-test lens | 2 participants |
| Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test) | Cosmetic Appearance Preference | Competitor-control lens | 9 participants |
| Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test) | Cosmetic Appearance Preference | No preference | 0 participants |
| Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test) | Cosmetic Appearance Preference | CVI-test lens | 1 participants |
| Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test) | Cosmetic Appearance Preference | CVI-test lens | 5 participants |
| Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test) | Cosmetic Appearance Preference | Competitor-control lens | 4 participants |
| Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test) | Cosmetic Appearance Preference | No preference | 1 participants |
| Group 4 - Azul (Competitor-control) vs. Blue (CVI-test) | Cosmetic Appearance Preference | Competitor-control lens | 5 participants |
| Group 4 - Azul (Competitor-control) vs. Blue (CVI-test) | Cosmetic Appearance Preference | No preference | 1 participants |
| Group 4 - Azul (Competitor-control) vs. Blue (CVI-test) | Cosmetic Appearance Preference | CVI-test lens | 4 participants |