Asian Clinical Evaluation of an Investigational Contact Lens for Cosmetic Effect

Not Applicable

Completed

• Conditions: Cosmetic Appearance
• Interventions: Device: nelfilcon A contact lens with print; Device: etafilcon A contact lens with print

• Registration Number: NCT01446835
• Lead Sponsor: CIBA VISION

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.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-03
• Study First Submitted QC: 2011-10-03
• Study First Posted: 2011-10-05
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2012-01
• Last Update Submitted: 2012-06-26
• Last Update Posted: 2012-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 151

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
nelfilcon A	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	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Singapore Polytechnic; 🇸🇬 Spoc, W115, Singapore