Asian Clinical Evaluation of an Investigational Contact Lens for Cosmetic Effect

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

Study Overview

• Status: Completed
• Conditions: Cosmetic Appearance
• Intervention / Treatment: Device: nelfilcon A contact lens with print; Device: etafilcon A contact lens with print

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 Type: Interventional
• Enrollment (Actual): 151
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • W115
    • Spoc, W115, Singapore, 139651
      • Singapore Polytechnic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nelfilcon A; 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.	Device: nelfilcon A contact lens with print; Investigational spherical contact lens
Active Comparator: etafilcon A; Etafilcon A printed contact lens randomly assigned to one eye, with nelfilcon A printed contact lens assigned to the fellow eye for contralateral wear.	Device: etafilcon A contact lens with print; Commercially marketed (Singapore) spherical contact lens; Other Names: 1-DAY ACUVUE DEFINE Vivid Style

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cosmetic Appearance Preference	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."	After 20 minutes of wear

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens Centration	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.	After insertion and before 20 minutes of wear

Collaborators and Investigators

• Sponsor: CIBA VISION
• Investigators: Principal Investigator: Danny Sim Chek Hoo, B Optom (Hons), Singapore Polytechnic

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: October 3, 2011
• First Submitted That Met QC Criteria: October 3, 2011
• First Posted (Estimate): October 5, 2011

Study Record Updates

• Last Update Posted (Estimate): June 28, 2012
• Last Update Submitted That Met QC Criteria: June 26, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: P-418-C-003