Asian Clinical Evaluation of an Investigational Contact Lens for Cosmetic Effect

NCT ID: NCT01446835

Last Updated: 2012-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2011-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cosmetic Appearance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

nelfilcon A contact lens with print

Intervention Type DEVICE

Investigational spherical contact lens

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.

Group Type ACTIVE_COMPARATOR

etafilcon A contact lens with print

Intervention Type DEVICE

Commercially marketed (Singapore) spherical contact lens

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

nelfilcon A contact lens with print

Investigational spherical contact lens

Intervention Type DEVICE

etafilcon A contact lens with print

Commercially marketed (Singapore) spherical contact lens

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

1-DAY ACUVUE DEFINE Vivid Style

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

CIBA VISION

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Danny Sim Chek Hoo, B Optom (Hons)

Role: PRINCIPAL_INVESTIGATOR

Singapore Polytechnic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Singapore Polytechnic

Spoc, W115, Singapore

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Singapore

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P-418-C-003

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.