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OpenTrials
Completed

NCT Number: NCT01446835

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.

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Key information

Conditions

Age range

18 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Singapore Polytechnic

Spoc, W115, 139651, Singapore

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nelfilcon A contact lens with print

Device

Investigational spherical contact lens

etafilcon A contact lens with print

Device

Commercially marketed (Singapore) spherical contact lens

Other names: 1-DAY ACUVUE DEFINE Vivid Style

Primary outcomes

  1. 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."

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

CIBA VISION

Industry

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 5, 2011
Registry last updated
Jun 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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