Cosmetic Effect
Conditions
Brief summary
The study is designed to test five new soft contact lens color pattern variants to determine whether the test lens makes the wearers eyes look bigger, more defined or enhances their overall appearance.
Interventions
DEVICEetafilcon test contact lens Variant AP
Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
DEVICEetafilcon test contact lens Variant JG
Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
DEVICEetafilcon test contact lens Variant CS
Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
DEVICEetafilcon test contact lens Variant VC
Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
DEVICEetafilcon test contact lens Variant LA
Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
1. The subject must be at least 18 years of age and no more than 39 years of age (inclusive) 2. Subjects must be Asian female 3. Subjects must be able to read Chinese 4. Subjects' monthly household income must be above HKD$ 10,000 5. Subjects must be habitual soft contact lens wearer or habitual limbal lens wearer or have a history of previous habitual lens wear. 6. Subjects' current/previous habitual lens must be in the disposable soft lens modality (ranging from daily to monthly) 7. Subjects must have dark colored iris (black, brown, or brown hazel) 8. Subjects must be concept acceptors. Concept acceptors are subjects that are willing to try new circle contact lenses. 9. Subjects must be classified as either 'Classic' or 'Vogue' on a Pattern Evaluation Screening Questionnaire. 10. Subjects must have acceptable near vision (without vision correction) and be able to see the test article lenses in the mirror 30 cm or closer. 11. Subjects must have best corrected visual acuity of 20/40 (Snellen or equivalent) or better in each eye. 12. Subjects must possess a functional/usable pair of spectacles and bring them to the visit (only if applicable-to the investigators discretion) 13. Subjects must read, understand, and sign the Statement of Informed Consent 14. Subjects must appear able and willing to adhere to the instructions set forth in this clinical protocol
Exclusion criteria
1. Subjects, or subjects' family member within the same household, that work for the following entities/companies: Government, advertising, marketing research or consultancy, media or public relations, companies that make, distribute or sell eyewear or contact lenses, eyecare practice (optometrist, ophthalmologist, optician) or the research center conducting the study 2. Habitual wearers of rigid gas permeable lenses within the last 3 months 3. Habitual soft conventional contact lens wearers (conventional lenses defined as replacement modality of greater than 1 month) 4. Any color deficiencies, by self report 5. Currently pregnant or breast-feeding a baby 6. Diabetes 7. Any ocular or systemic allergies or diseases which may interfere with contact lens wear 8. Any systemic disease, autoimmune disease, or use of medication which may interfere with contact lens wear, at the investigator's discretion 9. Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self report 10. Any grade 3 or greater Biomicroscopy findings (this includes, corneal edema, corneal staining, corneal vascularization, conjunctival injection, tarsal abnormalities, bulbar injection) on the FDA classification scale 11. Any active ocular abnormalities/conditions that may interfere with contact lens wear (this includes, but not limited to, chalazia, recurrent styes, pterygium, infection, etc.) 12. Any corneal distortion or moderate or above corneal distortion by self report 13. History of any corneal refractive surgery 14. Habitual contact lens is multifocal, monovision or worn as extended wear
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subject in Agreement (Bigger Eyes) | 15-20 Minutes Post Lens Insertion | Subjects' responses to the question Make my eye look bigger were categorized into a binary variable. If a subject responded Agrees Somewhat or Agrees Strongly then response=1. If a subject responds Neither Agrees nor Disagrees, Disagrees Somewhat Disagrees Strongly then response=0. The number of subjects with response=1 was reported for each lens. |
| Number of Subject in Agreement (Defines Eyes) | 15-20 Minutes Post Lens Insertion | Subjects' responses to the question Define my eye were categorized into a binary variable. If a subject responded Agrees Somewhat or Agrees Strongly then response=1. If a subject responds Neither Agrees nor Disagrees, Disagrees Somewhat Disagrees Strongly then response=0. The number of subjects with response=1 was reported for each lens. |
| Number of Subject in Agreement (Enhance Eyes) | 15-20 Minutes Post Lens Insertion | Subjects' responses to the question Enhance my overall appearance were categorized into a binary variable. If a subject responded Agrees Somewhat or Agrees Strongly then response=1. If a subject responds Neither Agrees nor Disagrees, Disagrees Somewhat Disagrees Strongly then response=0. The number of subjects with response=1 was reported for each lens. |
Countries
Hong Kong
Participant flow
Pre-assignment details
A total of 257 subjects were enrolled into this study. Of the enrolled subjects, 240 subjects were dispensed at least 1 study lenses, while 17 subjects failed to meet the eligibility criteria. No subjects were discontinued during the course of this study.
Participants by arm
| Arm | Count |
|---|---|
| AP-CS-LA-JG-VC All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 12 |
| AP-JG-CS-VC-LA All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 12 |
| AP-LA-VC-CS-JG All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 12 |
| AP-VC-JG-LA-CS All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 12 |
| CS-AP-VC-JG-LA All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 12 |
| CS-JG-AP-LA-VC All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 12 |
| CS-VC-LA-AP-JG All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 12 |
| CS-LA-JG-VC-AP All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 12 |
| JG-AP-LA-VC-CS All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 12 |
| JG-CS-VC-LA-AP All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 12 |
| JG-LA-CS-AP-VC All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 12 |
| JG-VC-AP-CS-LA All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 12 |
| LA-AP-JG-CS-VC All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 12 |
| LA-CS-AP-VC-JG All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 12 |
| LA-JG-VC-AP-CS All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 12 |
| LA-VC-CS-JG-AP All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 12 |
| VC-AP-CS-LA-JG All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 12 |
| VC-CS-JG-AP-LA All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 12 |
| VC-JG-LA-CS-AP All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 12 |
| VC-LA-AP-JG-CS All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | 12 |
| Total | 240 |
Baseline characteristics
| Characteristic | JG-LA-CS-AP-VC | AP-JG-CS-VC-LA | AP-LA-VC-CS-JG | AP-VC-JG-LA-CS | CS-AP-VC-JG-LA | CS-JG-AP-LA-VC | CS-VC-LA-AP-JG | CS-LA-JG-VC-AP | JG-AP-LA-VC-CS | JG-CS-VC-LA-AP | JG-VC-AP-CS-LA | LA-AP-JG-CS-VC | LA-CS-AP-VC-JG | LA-JG-VC-AP-CS | LA-VC-CS-JG-AP | VC-AP-CS-LA-JG | VC-CS-JG-AP-LA | VC-JG-LA-CS-AP | VC-LA-AP-JG-CS | Total | AP-CS-LA-JG-VC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 27.5 Years STANDARD_DEVIATION 5.04 | 26.9 Years STANDARD_DEVIATION 5.78 | 27.9 Years STANDARD_DEVIATION 4.96 | 28.0 Years STANDARD_DEVIATION 5.8 | 30.3 Years STANDARD_DEVIATION 6.06 | 27.5 Years STANDARD_DEVIATION 4.93 | 28.2 Years STANDARD_DEVIATION 6.99 | 26.8 Years STANDARD_DEVIATION 6.58 | 28.9 Years STANDARD_DEVIATION 5.62 | 26.6 Years STANDARD_DEVIATION 4.27 | 27.3 Years STANDARD_DEVIATION 5.88 | 29.1 Years STANDARD_DEVIATION 5.37 | 26.8 Years STANDARD_DEVIATION 4.37 | 27.85 Years STANDARD_DEVIATION 5.5 | 26.3 Years STANDARD_DEVIATION 5.8 | 27.8 Years STANDARD_DEVIATION 6.29 | 29.9 Years STANDARD_DEVIATION 6.53 | 27.6 Years STANDARD_DEVIATION 2.97 | 30.1 Years STANDARD_DEVIATION 5.11 | 28.0 Years STANDARD_DEVIATION 5.46 | 29.1 Years STANDARD_DEVIATION 5.84 |
| Race/Ethnicity, Customized Chinese | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 240 Participants | 12 Participants |
| Region of Enrollment China | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 240 Participants | 12 Participants |
| Sex: Female, Male Female | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 240 Participants | 12 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 |
Outcome results
Primary
Number of Subject in Agreement (Bigger Eyes)
Subjects' responses to the question Make my eye look bigger were categorized into a binary variable. If a subject responded Agrees Somewhat or Agrees Strongly then response=1. If a subject responds Neither Agrees nor Disagrees, Disagrees Somewhat Disagrees Strongly then response=0. The number of subjects with response=1 was reported for each lens.
Time frame: 15-20 Minutes Post Lens Insertion
Population: Subjects that completed all study visits without a major protocol deviation impacting any of the primary endpoints
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AP- Etafilcon A | Number of Subject in Agreement (Bigger Eyes) | 187 Participants |
| CS- Etafilcon A | Number of Subject in Agreement (Bigger Eyes) | 213 Participants |
| JG-etafilcon A | Number of Subject in Agreement (Bigger Eyes) | 206 Participants |
| LA-etafilcon A | Number of Subject in Agreement (Bigger Eyes) | 209 Participants |
| VC- Etafilcon A | Number of Subject in Agreement (Bigger Eyes) | 208 Participants |
Primary
Number of Subject in Agreement (Defines Eyes)
Subjects' responses to the question Define my eye were categorized into a binary variable. If a subject responded Agrees Somewhat or Agrees Strongly then response=1. If a subject responds Neither Agrees nor Disagrees, Disagrees Somewhat Disagrees Strongly then response=0. The number of subjects with response=1 was reported for each lens.
Time frame: 15-20 Minutes Post Lens Insertion
Population: Subjects that completed all study visits without a major protocol deviation impacting any of the primary endpoints
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AP- Etafilcon A | Number of Subject in Agreement (Defines Eyes) | 175 Participants |
| CS- Etafilcon A | Number of Subject in Agreement (Defines Eyes) | 189 Participants |
| JG-etafilcon A | Number of Subject in Agreement (Defines Eyes) | 180 Participants |
| LA-etafilcon A | Number of Subject in Agreement (Defines Eyes) | 188 Participants |
| VC- Etafilcon A | Number of Subject in Agreement (Defines Eyes) | 192 Participants |
Primary
Number of Subject in Agreement (Enhance Eyes)
Subjects' responses to the question Enhance my overall appearance were categorized into a binary variable. If a subject responded Agrees Somewhat or Agrees Strongly then response=1. If a subject responds Neither Agrees nor Disagrees, Disagrees Somewhat Disagrees Strongly then response=0. The number of subjects with response=1 was reported for each lens.
Time frame: 15-20 Minutes Post Lens Insertion
Population: Subjects that completed all study visits without a major protocol deviation impacting any of the primary endpoints
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AP- Etafilcon A | Number of Subject in Agreement (Enhance Eyes) | 167 Participants |
| CS- Etafilcon A | Number of Subject in Agreement (Enhance Eyes) | 180 Participants |
| JG-etafilcon A | Number of Subject in Agreement (Enhance Eyes) | 177 Participants |
| LA-etafilcon A | Number of Subject in Agreement (Enhance Eyes) | 170 Participants |
| VC- Etafilcon A | Number of Subject in Agreement (Enhance Eyes) | 185 Participants |