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

Alcon

Status: Completed

Conditions: Refractive Error

Treatments: Device: Delefilcon A contact lenses; Device: Narafilcon A contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT02710292

CLS104-P001

Details and patient eligibility

About

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.

Enrollment: 104 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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;
• Other protocol-specified inclusion criteria may apply.

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;
• Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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104 participants in 2 patient groups

DT1, then TE

Other group

Description:

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.

Treatment:

Device: Narafilcon A contact lenses

Device: Delefilcon A contact lenses

TE, then DT1

Other group

Description:

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.

Treatment:

Device: Narafilcon A contact lenses

Device: Delefilcon A contact lenses