Asian Clinical Evaluation of an Investigational Contact Lens for Cosmetic Effect

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01446835
First received: October 3, 2011
Last updated: June 26, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention
Cosmetic Appearance
Device: nelfilcon A contact lens with print
Device: etafilcon A contact lens with print

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Cosmetic Appearance Preference [ Time Frame: After 20 minutes of wear ] [ Designated as safety issue: No ]
    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:
  • Lens Centration [ Time Frame: After insertion and before 20 minutes of wear ] [ Designated as safety issue: No ]
    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.


Enrollment: 151
Study Start Date: October 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01446835

Locations
Singapore
Singapore Polytechnic
Spoc, W115, Singapore, 139651
Sponsors and Collaborators
CIBA VISION
Investigators
Principal Investigator: Danny Sim Chek Hoo, B Optom (Hons) Singapore Polytechnic
  More Information

No publications provided

Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT01446835     History of Changes
Other Study ID Numbers: P-418-C-003
Study First Received: October 3, 2011
Last Updated: June 26, 2012
Health Authority: Singapore: Domain Specific Review Boards

ClinicalTrials.gov processed this record on September 16, 2014