Asian Clinical Evaluation of an Investigational Contact Lens for Cosmetic Effect

Cosmetic Appearance Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01446835
• Other study ID #: P-418-C-003
• Status: Completed
• Phase: N/A
• First received: October 3, 2011
• Last updated: June 26, 2012
• Start date: October 2011
• Est. completion date: November 2011

Study information

• Verified date: January 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Cosmetic Appearance

Intervention

Device:
• nelfilcon A contact lens with print
Investigational spherical contact lens
• etafilcon A contact lens with print
Commercially marketed (Singapore) spherical contact lens

Locations

Country	Name	City	State
Singapore	Singapore Polytechnic	Spoc	W115

Sponsors (1)

Lead Sponsor	Collaborator
CIBA VISION

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No