Asian Clinical Evaluation of an Investigational Contact Lens for Cosmetic Effect

NCT01446835 — Not applicable, Completed, 151 participants, CIBA VISION

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Registry	NCT01446835
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, single group, masking: single
Enrollment	151 (Actual)
Sponsor	CIBA VISION (Industry)
Conditions	Cosmetic Appearance
Interventions	nelfilcon A contact lens with print, etafilcon A contact lens with print (Device)
Dates	start 2011-10-01, primary completion 2011-11-01, completion 2011-11-01, first posted 2011-10-05, last updated 2012-06-28
Locations	1 site in Singapore

-Summary

The purpose of this study is to compare the cosmetic appearance of two different contact lenses on Asian eyes.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
nelfilcon A	Experimental	Device: nelfilcon A contact lens with print	Nelfilcon A printed contact lens randomly assigned to one eye, with etafilcon A printed contact lens assigned to the fellow eye for contralateral wear. Lenses will be worn for 20 minutes.
etafilcon A	Active comparator	Device: etafilcon A contact lens with print	Etafilcon A printed contact lens randomly assigned to one eye, with nelfilcon A printed contact lens assigned to the fellow eye for contralateral wear.

nelfilcon A contact lens with print (Device): Investigational spherical contact lens
etafilcon A contact lens with print (Device), also known as 1-DAY ACUVUE DEFINE Vivid Style: Commercially marketed (Singapore) spherical contact lens

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: Female, ages: 18 Years to 30 Years

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 exclusion criteria may apply.

+Locations (1)

Facility	City	Country	Status
Singapore Polytechnic	Spoc, W115	Singapore

+Investigators

Danny Sim Chek Hoo, B Optom (Hons), Principal investigator, Singapore Polytechnic