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

Clinical Evaluation of DAILIES TOTAL 1® in Japanese Population - Comparison of Lens Centration Between DAILIES TOTAL 1® and 1-DAY ACUVUE® TruEye®

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.

Study Overview

• Status: Completed
• Conditions: Refractive Error
• Intervention / Treatment: Device: Delefilcon A contact lenses; Device: Narafilcon A contact lenses

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan, 107-0052
    • Contact Alcon Japan, Ltd. for Trial Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Device: Delefilcon A contact lenses; Other Names: DT1; DAILIES TOTAL 1®; Device: Narafilcon A contact lenses; Other Names: 1-DAY ACUVUE® TruEye®
Other: 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.	Device: Delefilcon A contact lenses; Other Names: DT1; DAILIES TOTAL 1®; Device: Narafilcon A contact lenses; Other Names: 1-DAY ACUVUE® TruEye®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With Investigator-rated Lens Centration of "Optimal" After 10 Days of Wear	Lens centration was assessed by the investigator on a 5-point scale, where 0=Optimal and 4=Severe decentration (with corneal exposure). Both eyes contributed to the analysis.	Day 10, each product

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Manager, Clinical Development, Alcon Japan, Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2016
• Primary Completion (Actual): September 14, 2016
• Study Completion (Actual): September 14, 2016

Study Registration Dates

• First Submitted: March 11, 2016
• First Submitted That Met QC Criteria: March 11, 2016
• First Posted (Estimate): March 16, 2016

Study Record Updates

• Last Update Posted (Actual): July 2, 2018
• Last Update Submitted That Met QC Criteria: May 31, 2018
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CLS104-P001

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No