Asian Clinical Evaluation of an Investigational Contact Lens for Cosmetic Effect

NCT01446835 | Completed

• 1 other identifier: P-418-C-003
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cosmetic Appearance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Lens Centration

  After insertion and before 20 minutes of wear

Study Arms (2)

nelfilcon A

EXPERIMENTAL

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

etafilcon A

ACTIVE COMPARATOR

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

Interventions

nelfilcon A contact lens with print DEVICE

Investigational spherical contact lens

nelfilcon A

etafilcon A contact lens with print DEVICE

Commercially marketed (Singapore) spherical contact lens

Also known as: 1-DAY ACUVUE DEFINE Vivid Style

etafilcon A

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• CIBA VISION: lead

Study Sites (1)

Singapore Polytechnic

Spoc, W115, 139651, Singapore

Location

Study Officials

• Danny Sim Chek Hoo, B Optom (Hons)

  Singapore Polytechnic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2011
• First Posted: October 5, 2011
• Study Start: October 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: June 28, 2012

Record last verified: 2012-01

Locations

SG (1)