Clinical Evaluation of DAILIES TOTAL 1® Performance in a Japanese Population

NCT ID: NCT02710292

Last Updated: 2018-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-25
• Study Completion Date: 2016-09-14

Brief Summary

The purpose of this study is to compare DAILIES TOTAL1® (DT1) to 1-DAY ACUVUE® TruEye® (TE) for Investigator-rated successful lens centration in Japanese population.

Conditions

Refractive Error

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

DT1, then TE

Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality.

Group Type: OTHER

Delefilcon A contact lenses

Intervention Type: DEVICE

Narafilcon A contact lenses

Intervention Type: DEVICE

TE, then DT1

Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality.

Group Type: OTHER

Delefilcon A contact lenses

Intervention Type: DEVICE

Narafilcon A contact lenses

Intervention Type: DEVICE

Interventions

Delefilcon A contact lenses

Intervention Type: DEVICE

Narafilcon A contact lenses

Intervention Type: DEVICE

Other Intervention Names

DAILIES TOTAL 1®; DT1; 1-DAY ACUVUE® TruEye®

Eligibility Criteria

Inclusion Criteria

• Must sign an informed consent form;
• Habitual current daily disposable soft contact lenses wearer;
• Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Questionnaire;
• Lenses within the power range specified in the protocol;
• Vision correctable to 20/25 or 0.1 logMAR (logarithmic minimum angle of resolution) or better in each eye at distance with pre-study contact lenses at Visit1;
• Acceptable lens fit with both study contact lenses;
• Willing to wear lenses every day or at least for a minimum of 10 days, 6 hours per day, every day if possible and attend all study visits;

Exclusion Criteria

• Currently wearing DT1 or TE sphere lenses;
• Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
• Use of systemic or ocular medications in which contact lens wear could be contraindicated as determined by the investigator;
• Eye injury or surgery within 12 weeks immediately prior to enrollment;
• History of herpetic keratitis, ocular surgery or irregular cornea;
• Prior refractive surgery;
• Monocular (only 1 eye with functional vision) or fit with only 1 lens;
• Participation in any clinical trial within 30 days of the enrollment visit;

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Manager, Clinical Development

Role: STUDY_DIRECTOR

Alcon Japan, Ltd.

Locations

Contact Alcon Japan, Ltd. for Trial Locations

Tokyo, , Japan

Countries

Japan

Other Identifiers

CLS104-P001

Identifier Type: -

Identifier Source: org_study_id