Cosmetic Appearance
Conditions
Brief summary
The purpose of this study is to compare the cosmetic appearance of two different contact lenses on Asian eyes.
Detailed description
Participants will be asked to evaluate the cosmetic appearance of two different contact lenses worn contralaterally for 20 minutes. No vision or comfort variables will be assessed in this cosmetic appearance and lens fit non-dispensing study.
Interventions
DEVICEnelfilcon A contact lens with print
Investigational spherical contact lens
DEVICEetafilcon A contact lens with print
Commercially marketed (Singapore) spherical contact lens
Sponsors
CIBA VISION
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 30 Years
Healthy volunteers
No
Inclusion criteria
* Female between 18 and 30 years of age (inclusive). * If under 21 years of age, subject must sign informed assent and have written consent of parent or guardian to participate. * Sign written Informed Consent. * Chinese, Japanese, or Korean descent. * Brown eye color. * Spherical equivalent refractive error of -0.50 diopter (D) and between (-1.50 to -2.50D), (-3.50 to -4.50D) and (-5.50 to -6.50D). * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Eye injury or surgery within twelve weeks prior to enrollment. * Pre-existing ocular irritation that would preclude contact lens fitting. * Currently enrolled in any clinical ophthalmic trial. * Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of accessory solutions as determined by the investigator. * Any use of medications for which contact lens wear could be contraindicated as determined by the investigator. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cosmetic Appearance Preference | After 20 minutes of wear | Participant will be asked on a questionnaire, Which lens do you prefer for looking more natural? Subject will record on the questionnaire, Left lens, Right lens, or No preference. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lens Centration | After insertion and before 20 minutes of wear | Investigator will assess lens centration using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens centration will be graded on a 5-point scale, with 0 being centered and 4 being severe decentration with corneal exposure. |
Countries
Singapore
Outcome results
None listed