Asian Clinical Evaluation of an Investigational Contact Lens for Cosmetic Effect
|ClinicalTrials.gov Identifier: NCT01446835|
Recruitment Status : Completed
First Posted : October 5, 2011
Last Update Posted : June 28, 2012
|Condition or disease||Intervention/treatment||Phase|
|Cosmetic Appearance||Device: nelfilcon A contact lens with print Device: etafilcon A contact lens with print||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||151 participants|
|Intervention Model:||Single Group Assignment|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
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 Name: 1-DAY ACUVUE DEFINE Vivid Style
- Cosmetic Appearance Preference [ Time Frame: 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."
- Lens Centration [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01446835
|Spoc, W115, Singapore, 139651|
|Principal Investigator:||Danny Sim Chek Hoo, B Optom (Hons)||Singapore Polytechnic|