Asian Clinical Evaluation of an Investigational Contact Lens for Cosmetic Effect

Ciba Vision

Status: Completed

Conditions: Cosmetic Appearance

Treatments: Device: etafilcon A contact lens with print; Device: nelfilcon A contact lens with print

Study type: Interventional

Funder types: Industry

Identifiers

NCT01446835

P-418-C-003

Details and patient eligibility

About

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

Full 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.

Enrollment: 151 patients

Sex: Female

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

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.

Trial design

151 participants in 2 patient groups

nelfilcon A

Experimental group

Description:

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.

Treatment:

Device: nelfilcon A contact lens with print

etafilcon A

Active Comparator group

Description:

Etafilcon A printed contact lens randomly assigned to one eye, with nelfilcon A printed contact lens assigned to the fellow eye for contralateral wear.

Treatment:

Device: etafilcon A contact lens with print